812.219 — IvDO
English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.
of 4 May 2022 (Status as of 1 January 2025)
The Swiss Federal Council,
based on the Therapeutic Products Act of 15 December 2000 1 (TPA),
Article 21 number 2 of the Electricity Act of 24 June 1902 2 ,
Article 5 of the Metrology Act of 17 June 2011 3 ,
Article 4 paragraph 1 of the Federal Act of 12 June 2009 4 on Product Safety,
Article 37 paragraph 1 of the Radiological Protection Act of 22 March 1991 5 and
in implementation of the Federal Act of 6 October 1995 6 on Technical Barriers to Trade,
ordains:
This Ordinance applies to in vitro diagnostic medical devices and accessories as defined in Article 3 (Devices).
For devices which, when placed on the market or put into service, incorporate as an integral part a medical device in accordance with Article 3 paragraphs 1 and 2 of the Medical Devices Ordinance of 1 July 2020 7 (MedDO), this Ordinance applies only to the in vitro diagnostic medical device part.
This Ordinance does not apply to: a. products for general laboratory use or research-use only products, unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination; b. invasive sampling products or products which are directly applied to the human body for the purpose of obtaining a specimen; c. internationally certified reference materials; d. materials used for external quality assessment schemes; e. devices intended exclusively for veterinary diagnostic purposes.
An in vitro diagnostic medical devicemeans any medical device in accordance with Article 3 paragraphs 1 and 2 MedDO8 which:
Specimen receptacles shall also be deemed to be in vitro diagnostic medical devices.
Accessory for an in vitro diagnostic medical device means an article which, whilst not being itself an in vitro diagnostic medical device, is intended by its manufacturer to be used together with one or more particular in vitro diagnostic medical device(s), to: specifically enable the in vitro diagnostic medical device(s) to be used in accordance with its/their intended purpose(s); or to specifically and directly assist the medical functionality of the in vitro diagnostic medical device or in vitro diagnostic medical devices in terms of its/their intended purpose(s).
In this Ordinance:
The definitions set out in Article 2 points 3, 5–19, 24, 30–41, 44–45, 49–56, 60–72 and 74 EU-IVDR also apply.
The equivalent terms specified in Annex 1 and as used in EU-IVDR 11 and this Ordinance shall apply.
Where this Ordinance makes reference to provisions of EU-IVDR which, in turn, refer to other provisions of EU-IVDR or other EU legislative acts, those provisions shall also apply. The version in the footnote to Article 4 paragraph 1 letter e is authoritative for references to EU-IVDR, while the versions of the relevant EU acts set out in Annex 2 point 1 apply to references to other EU acts. This provision excludes onward references to the EU acts listed in Annex 2 number 2; here the Swiss provisions listed in the Annex shall apply.
A device may be placed on the market or put into service only if it complies with this Ordinance when duly supplied and properly installed, maintained and used in accordance with its intended purpose.
Devices shall meet the general safety and performance requirements set out in Annex I to EU-IVDR 12 , taking into account its intended purpose.
If the device complies with the applicable technical standards or common specifications designated by the Swiss Agency for Therapeutic Products (Swissmedic), or relevant sections thereof, or with pharmacopoeial requirements in accordance with the Pharmacopoeia Ordinance of 17 October 2001 13 , then the device shall be presumed to comply with those requirements of this Ordinance covered by the applicable designated technical standards or common specifications, or relevant sections thereof, or by the pharmacopoeial requirements.
The presumption in paragraph 3 also applies to compliance with the system or process requirements to be fulfilled in accordance with this Ordinance by economic operators, including requirements relating to quality management systems, risk management, post-market surveillance systems, performance studies, clinical evidence or post-market performance follow-up.
Compliance with the common specifications in paragraph 3 is required unless the manufacturer can duly justify that the adopted solutions ensure an equivalent level of safety and performance.
Devices offered in Switzerland by means of information society services – specifically an online service – that fulfil the conditions set out in paragraph 5 must comply with this Ordinance.
Devices offered to users in Switzerland online or via some other form of distance sales are considered to have been made available on the market.
Similarly, devices although not placed on the market, but used in the context of a commercial activity, whether in return for payment or free of charge, for the provision of a diagnostic or therapeutic service offered by means of information society services or by other means of communication shall also comply with this Ordinance.
Upon request by the Swiss Agency for Therapeutic Products (Swissmedic), any natural or legal person offering diagnostic or therapeutic services in accordance with paragraph 1 shall make available a copy of the declaration of conformity.
A device is deemed to be supplied via an information society service if that service:
Devices that are also machines within the meaning of Article 1 of the Machine Ordinance of 2 April 2008 14 must satisfy the relevant general safety and health protection requirements of the Machine Ordinance where these requirements are more specific than those of Chapter II of Annex I to EU-IVDR 15 .
Devices manufactured and used solely within healthcare institutions, with the exception of devices for performance studies, are deemed to have been put into service. Such devices are subject to the pertinent general safety and performance requirements of Annex I EU-IVDR 16 , but not to any of the other requirements set out in this Ordinance, provided the requirements of Article 5 paragraph 5 letters a–i EU-IVDR are fulfilled.
The documentation specified in Article 5 paragraph 5 letter g EU-IVDR is required for devices of all classes in accordance with Article 14.
Paragraphs 1 and 2 do not apply to devices manufactured on an industrial scale.
Healthcare institutions that manufacture and use devices as specified in Article 9 shall provide the following information to Swissmedic prior to putting the devices into service:
Any other relevant information about these devices must be submitted to Swissmedic upon request.
Changes to the information required in paragraph 1 must be reported to Swissmedic within 30 days.
Depending on the risk inherent to a device and its use, Swissmedic may exempt devices manufactured and used in accordance with Article 9 from the reporting obligation.
Any natural or legal person who makes available on the market an item intended to replace an identical or similar integral part or component of a device that is defective or worn in order to maintain or restore the function of the device without changing its performance or safety characteristics or its intended purpose, shall ensure that the item does not adversely affect the safety and performance of the device. Supporting evidence must be kept available for the competent authority.
An item that is intended to replace a part or component of a device and that significantly changes the performance or safety characteristics or the intended purpose of the device shall be considered to be a device and shall meet the requirements laid down in this Ordinance.
Devices placed on the market in Switzerland or made available on the Swiss market must bear a conformity marking in accordance with Annex 4. The conformity marking presented in Annex V to EU-IVDR 17 is also a permissible conformity marking.
The following must not bear a conformity marking:
Where the conformity of a device has to be assessed by a conformity assessment body that is designated in accordance with this Ordinance or recognised in connection with an international agreement (designated body), the identification number of this body must be affixed to the conformity marking.
The conformity marking and, where necessary, the associated identification number shall be affixed to the device itself or its sterile packaging.
Where this is not possible or practicable owing to the nature of the device, the conformity marking and, where necessary, the associated identification number must be displayed on the packaging.
The conformity marking shall also appear on the instructions for use and on the sales packaging.
The requirements of Article 18 paragraphs 3–6 EU-IVDR 19 and the general principles stated in Article 30 of Regulation (EC) No. 765/2008 20 must also be observed when affixing the conformity marking.
Devices shall be divided into classes A, B, C and D, taking into account the intended purpose of the devices and their inherent risks. This classification must comply with the provisions of Annex VIII to EU-IVDR 21 .
Product information comprises the labelling and instructions for use. It is governed by Chapter III of Annex I to EU-IVDR 22 .
It must be written in all three official languages of Switzerland. Symbols established by means of technical standards may be used to replace written statements.
The product information may be provided in fewer than the three official languages of Switzerland or in English, provided that:
If requested, additional information must be provided to users in one of the official languages of Switzerland.
If a product cannot be, or cannot yet be, placed on the market as an in vitro diagnostic medical device, but may be confused with such a device, the claims relating to the said product must indicate clearly and legibly that it is not an in vitro diagnostic medical device and is not suitable for medical purposes.
Devices intended solely for demonstration and presentation purposes must be specifically labelled as such. The information must be clearly visible and comprehensible.
Misleading or contradictory information on a device's intended purpose, safety and performance is forbidden.
For devices for self-testing or for near-patient testing, the information stated in Chapter III of Annex I EU-IVDR should be easily understandable and written in the three official languages.
For devices not intended for self-testing and not placed on the market in accordance with Articles 81 and 82, the details of the authorised representative as specified in Chapter III section 20.2 letter d of Annex I EU-IVDR may be provided in a document accompanying the device. 23
The manufacturer shall assign to the device and all superordinate packaging layers a unique device identifier (UDI 24 ) prior to placing it on the market.
The manufacturer must state the UDI on the labelling of the device and all higher levels of packaging. Shipping containers are not considered as a higher level of packaging. .
The manufacturer shall maintain a list of all the UDIs he has assigned. This list is part of the technical documentation specified in Annex II to EU-IVDR 25 . It must be kept up-to-date at all times.
The obligations and modalities associated with device identification and registration are governed by Articles 24 and 26 and Annex VI to EU--IVDR, taking account of the amendments to this Annex adopted by the European Commission by means of delegated acts 26 .
… 27
Any natural or legal person who is domiciled in Switzerland and makes devices available on the market in Switzerland or in a contracting state must, upon request, provide the authorities which are responsible for controls in the field of market surveillance, with the declaration of conformity.
The demonstration of conformity with the general safety and performance requirements shall also include a performance evaluation in accordance with Article 56 EU-IVDR 28 .
On a duly justified request, Swissmedic may authorise the placing on the market and putting into service of a specific device the use of which is in the interest of public health, patient safety or health even though:
Individual devices, apart from devices for self-testing, that have not undergone the relevant conformity assessment procedure may be placed on the market and used
without authorisation from Swissmedic provided:
For devices placed on the market exclusively within the armed forces or within the framework of their specific tasks, the Federal Department of Home Affairs (FDHA) may, in agreement with the Federal Department of Defence, Civil Protection and Sports, grant exemptions.
The conformity assessment procedure is governed by Article 48 and by Annexes IX–XI to EU-IVDR 29 .
When a designated body is involved, all the information necessary for the conformity assessment must be made available to it.
Manufacturers must not simultaneously apply to more than one designated body in Switzerland or a contracting state to carry out a conformity assessment procedure for the same device.
Any natural or legal person who applies to a designated body must declare whether an application to a different designated body in Switzerland or a contracting state has been withdrawn before a decision was issued or rejected by a different designated body in Switzerland or a contracting state.
If a manufacturer withdraws its application to have a conformity assessment procedure carried out before the designated body has issued its decision on the assessment, the designated body in question shall notify Swissmedic and the other designated bodies.
Where a manufacturer voluntarily changes the designated body, it must comply with the requirements of Article 53 EU-IVDR 30 .
The designated bodies issue certificates of conformity in accordance with Annexes IX–XI to EU-IVDR 31 (Certificates).
The certificates must be issued in one of the three official languages of Switzerland or in English.
They must, as a minimum, include the information required in Annex XII to EU-IVDR, taking account of the amendments to this Annex adopted by the European Commission by means of delegated acts 32 .
Certificates issued by bodies designated under EU law and domiciled in a state of the EU or European Economic Area (EEA) but not recognised by an international agreement are deemed equivalent to certificates issued by Swiss bodies if it can be credibly demonstrated that:
Certificates are valid for a maximum of five years. The expiry date must be indicated on the certificate.
At the manufacturer's request, the validity of the certificate may be extended by a maximum of five years following a re- assessment carried out in accordance with the applicable conformity assessment procedure. Certificates may be extended more than once.
Any supplement to a certificate is valid for the same period as the certificate to which it belongs.
If a designated body finds that a manufacturer no longer fulfils the requirements of this Ordinance, it shall impose on that manufacturer a suitable deadline for restoring compliance.
If this deadline passes without the manufacturer taking suitable corrective action, the designated body shall suspend, revoke or restrict the certificate in question.
A certificate that has been amended, suspended or revoked by a designated body must no longer be used in its original form.
The designated body shall provide Swissmedic and the other designated bodies with:
Notifications of certificates for Class D devices, with the exception of applications to supplement or renew existing certificates, must include the documents specified in Article 50 paragraph 1 EU-IVDR 33 .
If the applicable conformity assessment procedure has demonstrated that the requirements of this Ordinance have been fulfilled, the manufacturer of devices, apart from devices used for performance studies, issues a declaration of conformity. The manufacturer shall continuously update this declaration.
The declaration of conformity shall include the information required in Annex IV to EU-IVDR 34 , taking account of the amendments to this Annex adopted by the European Commission by means of delegated acts 35 . It must be written in one of the three official languages of Switzerland or English or translated into one of these languages.
If a device also requires a manufacturer's declaration of conformity for aspects not covered by this Ordinance but nevertheless required by other legislation in order to demonstrate compliance with that legislation, a single declaration of conformity shall be drawn up.
By drawing up the declaration of conformity, the manufacturer assumes responsibility for compliance with the requirements of this Ordinance and all other legislation applicable to the device.
Swissmedic shall only designate conformity assessment bodies which are domiciled in Switzerland, have completed an assessment procedure in accordance with Article 27 and which comply with the requirements set out in Annex VII to EU-IVDR 36 .
Applications for designation must be submitted to Swissmedic. They must in particular include:
Swissmedic shall, within thirty days, check that the application for designation is complete, and shall request the applicant to provide any missing information.
It shall review the application and accompanying documents and draw up a preliminary assessment report.
Swissmedic shall conduct an on-site assessment of the conformity assessment body and, if relevant, of all sub-contractors and subsidiaries.
If Swissmedic identifies non-compliances in the course of its assessment, it shall draw up a list of non-compliances for the applicant. Swissmedic shall set a deadline for the conformity assessment body by which the latter shall submit to Swissmedic a corrective action plan to address the non-compliances and a preventive action plan.
The plans shall indicate the root cause of the identified non-compliances and shall include a timeframe for implementation of the actions therein.
Swissmedic shall decide whether the proposed action is suitable and whether the timeframe for implementation is appropriate.
If Swissmedic approves the plans required under Article 27 paragraph 2, it shall prepare an assessment report.
This shall comprise the following:
Swissmedic shall issue the designation if the conformity assessment body meets the requirements.
The extension of designations is subject to the requirements and procedures laid out in Articles 26–28.
Designated bodies that delegate part of the work to sub-contractors or to subsidiaries bear full responsibility for the work carried out on their behalf by sub-contractors or by the subsidiaries.
They shall verify that the sub-contractor or the subsidiary meets the applicable requirements of Annex VII to EU-IVDR 37 .
They must notify Swissmedic if they delegate work under the terms of paragraph 1. They must be able to demonstrate to Swissmedic that the sub-contractor or the subsidiary is capable of carrying out the tasks assigned to it.
Conformity assessment activities may only be delegated if the designated body has informed the legal or natural person that applied for conformity assessment accordingly.
The designated bodies shall make publicly available a list of their subsidiaries.
The designated bodies, including their subsidiaries and sub-contractors, are required to keep available for Swissmedic at all times all data that is necessary for assessment, designation, monitoring and re-assessment, including the documents required to assess the qualifications of sub-contractors or subsidiaries. The data must be kept up-to-date at all times.
The designated bodies shall notify Swissmedic within 15 days of any change which may affect their compliance with the requirements of Annex VII to EU-IVDR 38 or their ability to conduct conformity assessments.
The designated bodies shall issue lists of the standard fees charged for their activities and make these lists publicly available.
If a designated body ceases to carry out its conformity assessment activities, it shall inform Swissmedic and the manufacturers concerned as soon as possible. In the case of a planned cessation of activities, notice must be given one year before the activities cease. Swissmedic shall revoke the designation at the time of cessation of activities.
The certificates remain valid for a maximum of nine months following the cessation of activities, provided another designated body assumes responsibility for the devices covered by those certificates and confirms this in writing.
The designated body assuming responsibility in accordance with paragraph 2 shall conduct a full assessment of the devices concerned before the nine-month period expires and before issuing new certificates for those devices.
Designation shall be suspended, restricted or revoked if the designated body:
Suspensions shall be imposed for a maximum of twelve months. They may be extended by a maximum of a further twelve months.
If its designation is suspended, restricted or revoked, the designated body must inform the manufacturers concerned within ten days.
In the event of its designation being restricted, suspended or revoked, the designated body shall suspend or revoke any certificates which were unduly issued.
If the designated body fails to fulfil this requirement, Swissmedic shall instruct it to suspend or revoke the certificates and set an appropriate deadline for doing so.
If Swissmedic suspends or restricts the designation of a designated body, the certificates concerned remain valid provided Swissmedic:
The certificates also remain valid if Swissmedic:
The designated body shall inform the manufacturers concerned or the persons or entities placing the devices concerned on the market.
Should Swissmedic ascertain that the designated body does not have the capability to support existing certificates issued, these certificates retain their validity if the manufacturer of the device in question confirms to Swissmedic or, if it is domiciled in a contracting state, to the competent authority there, in writing and within three months of designation being suspended or restricted that: another qualified designated body is temporarily assuming the monitoring functions; and that this designated body is responsible for the certificates during the period of suspension or restriction.
If Swissmedic revokes the designation of a designated body, the certificates affected remain valid for nine months provided:
Swissmedic may, within the limits of its competence, extend the provisional validity of the certificates for further periods of three months, which altogether must not exceed twelve months.
Swissmedic shall monitor the designated bodies and their subsidiaries and sub-contractors and carry out re-assessments. In the course of monitoring and re-assessing designated bodies and reviewing their assessments, Swissmedic shall take account of the requirements and procedures set out in Articles 40 and 41 EU-IVDR 39 .
It shall verify whether designated bodies still satisfy the requirements of Article 32 paragraph 1 and Annex VII to EU-IVDR three years after designation, and then every four years, in the course of a full re-assessment. This provision is subject to changes in assessment intervals resulting from delegated acts 40 issued by the European Commission.
Swissmedic shall carry out an on-site audit at least once a year to ascertain whether the designated bodies and, where necessary, their subsidiaries and sub-contractors fulfil the requirements and obligations of Annex VII to EU-IVDR.
For this purpose, it may at any time:
Manufacturers guarantee that their devices have been designed and manufactured in accordance with the requirements of this Ordinance when placing them on the market or putting them into service.
They must affix the conformity marking to their devices.
They must conduct a performance evaluation in accordance with Article 56 and Annex XIII to EU-IVDR 41 . They must update this performance evaluation based on the results of the post-market performance follow-up.
Manufacturers must specify in the technical documentation the information required in Annexes II and III to EU-IVDR 42 , taking account of the amendments to these Annexes made by the European Commission by means of delegated acts 43 .
Manufacturers must submit either the complete technical documentation or a summary thereof when requested to do so by the competent authority.
Manufacturers must ensure that the following documents are available to the competent authority for at least ten years after the last device covered by the declaration of conformity has been placed on the market: the complete technical documentation; the declaration of conformity; a copy of the certificates issued, including any amendments and supplements.
Manufacturers must have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of in vitro diagnostic medical devices.
Proof of the requisite expertise the person responsible for regulatory compliance possesses, the responsibilities of this person, exceptions and further modalities are governed by Article 15 EU-IVDR 44 .
The person responsible for regulatory compliance must have a deputy. If a number of persons are jointly responsible for regulatory compliance, their respective areas of responsibility shall be stipulated in writing.
The person responsible for regulatory compliance must suffer no disadvantage within the manufacturer's organisation in relation to the proper fulfilment of his or her duties, regardless of whether or not they are employees of the organisation.
The further obligations incumbent on manufacturers, particularly the requirements regarding their quality and risk management systems, are governed by Article 10 EU-IVDR 45 .
Where the manufacturer of a device is not domiciled in Switzerland, the device may only be placed on the market if the manufacturer designates an authorised representative domiciled in Switzerland by means of a written mandate.
The authorised representative is responsible for the formal and safety-related aspects of placing the device on the market.
The authorised representative’s rights and obligations and the scope of its mandate are governed by Article 11 EU-IVDR 46 .
The manufacturer and authorised representative may contractually agree that, instead of the authorised representative keeping available a copy of the technical documentation, the manufacturer shall, on request, submit the documentation straight to Swissmedic. The authorised representative must ensure that the documentation is submitted within seven days.
Changes in authorised representative are governed by Article 12 EU-IVDR.
Authorised representatives shall have permanently and continuously at their disposal at least one person who possesses the requisite expertise as regards the requirements for in vitro diagnostic medical devices under this Ordinance and who is responsible for regulatory compliance.
In other respects, Article 42 paragraphs 2–4 shall apply mutatis mutandis.
Importers may only place on the market devices that comply with this Ordinance. Before placing devices on the market, they shall verify that:
Importers shall indicate on the device or on its packaging or in a document accompanying the device, their name, place of business and the address where they can be contacted.
Where an importer considers or has reason to believe that a device is not in conformity with the requirements of this Ordinance, it must not place the device on the market until it has been brought into conformity.
The further obligations of importers prior to and after placing a device on the market are governed by Articles 13 and 16 paragraphs 3 and 4 EU-IVDR47. In particular, importers must comply with the following obligations:
When making a device available on the market, distributors must, in the context of their activities, act with due care in relation to the requirements applicable. Before making a device available on the market, distributors must verify that:
With the exception of paragraph 1 letter d, a sampling method may be used for the purposes of verification.
Where a distributor considers or has reason to believe that a device is not in conformity with the requirements of this Ordinance, it must not make the device available on the market until it has been brought into conformity.
The further obligations of distributors prior to and after making a device available on the market are governed by Articles 14 and 16 paragraphs 3 and 4 EU-IVDR48. In particular, distributors must fulfil the following obligations:
Manufacturers or their authorised representatives and importers must register the information required by Part A, Section 1, of Annex VI to EU-IVDR 49 with Swissmedic within three months of placing a device on the market for the first time.
The economic operator in question must report any changes to the information provided to Swissmedic within one week.
Further obligations and registration modalities are governed by Article 27 paragraph 3 and Article 28 EU-IVDR.
Swissmedic shall verify the information provided by the economic operators and assign them a Swiss single registration number (CHRN).
For each device, manufacturers must plan, establish, document, implement, maintain and update a post-market surveillance system in a manner that is proportionate to the risk class and appropriate for the type of device. That system shall be an integral part of the manufacturer's quality management system.
The system must be suited to actively and systematically gathering, recording and analysing relevant data on the quality, performance and safety of a device throughout its entire lifetime, and to drawing the necessary conclusions and to determining, implementing and monitoring any preventive and corrective actions.
The modalities of the system, particularly the resulting actions, updates and amendments to technical documentation, are governed by Article 78 paragraph 3 EU-IVDR 50 .
Should it become evident in the course of post-market surveillance that preventive and/or corrective actions are necessary, the manufacturer shall implement the appropriate measures and inform the competent authorities and, if applicable, the designated body.
If a manufacturer becomes aware of a serious incident in connection with a device that has been made available on the market, or takes action to prevent or minimise the risk of such an incident for medical or technical reasons (field safety corrective actions), it must report the fact in accordance with Article 59.
The post-market surveillance plan must satisfy the requirements of Section 1 of Annex III to EU-IVDR 51 . The plan shall be part of the technical documentation referred to in Annex II to EU-IVDR.
Manufacturers of class A and B devices must draw up a post-market surveillance report.
This report must contain:
The report is part of the post-market surveillance technical documentation specified in Annex III to EU-IVDR 52 .
The manufacturer must update the report when necessary and make it available to the designated body and the competent authority upon request.
Manufacturers of class C and D devices shall prepare a safety report for each device and, where relevant, for each category or group of devices.
Manufacturers of class C and D devices shall update the safety report when necessary, but at least annually.
The safety report must contain:
Throughout the lifetime of the device concerned, the safety report must set out:
The safety report forms part of the technical documentation specified in Annexes II and III to EU-IVDR 53 .
Manufacturers shall make their safety reports available to the designated body involved in the conformity assessment.
The designated body shall review the safety report for class D devices and record the outcome of its review with details of any action taken.
Manufacturers or their authorised representatives shall, upon request, make the safety report and the outcome of the designated body’s review, with details of any action taken, available to the competent authority.
For class C and D devices, other than devices for performance studies, the manufacturer must draw up a summary of safety and performance.
This summary shall be written in a way that is clear to the intended user and, if relevant, to the patient.
The minimum content of the summary is governed by Article 29 paragraph 2 EU-IVDR 54 .
The draft of the summary, together with the documentation, must be submitted to the designated body involved in the conformity assessment for validation by that body.
The manufacturer shall publish the summary after it has been validated.
The manufacturer must mention on the label or instructions for use where the summary is available.
Distributors and importers shall co-operate with manufacturers or authorised representatives to achieve an appropriate level of traceability of devices.
The duty of disclosure under Article 47c TPA applies for at least 10 years from the date on which the device was acquired or delivered.
Economic operators and healthcare institutions shall store and keep, preferably by electronic means, the UDI of devices which they have supplied or with which they have been supplied. The list of these devices, device categories or device groups is specified in implementing acts 55 of the EU Commission in accordance with Article 24 paragraph 11 letter a EU-IVDR 56 .
Manufacturers of devices made available on the market in Switzerland must report to Swissmedic:
Exemptions from this reporting obligation, modalities, periodic summary reports, trend reporting and analyses of serious incidents and field safety corrective actions are governed by Article 24 paragraph 5 and Articles 82–84 EU-IVDR 57 .
Where an authorised representative is required pursuant to Article 44, this representative is responsible for the reporting obligation in paragraph 1. Furthermore, the authorised representative shall submit the trend reports pursuant to paragraph 2 on incidents in Switzerland and abroad to Swissmedic without being requested to do so. Final reports prepared in accordance with Article 84 paragraph 5 EU-IVDR should be submitted to Swissmedic. The transfer of these obligations from the manufacturer to the authorised representative must be agreed in writing in the mandate.
Any professional who becomes aware of a serious incident when using devices must report this to the supplier and Swissmedic. The report may be submitted by a professional association. The timelines for doing so are as set out in Article 82 EU-IVDR.
Reports must be submitted to Swissmedic electronically and in machine-readable format. Swissmedic publishes information on electronic submission and the forms to be used with content specifications.
Hospitals must set up an internal reporting system within the framework of an established quality management system for the purpose of reporting under Article 59 paragraph 4.
They must designate a suitable competent person (vigilance contact person) with a medical or technical qualification to assume responsibility for reporting to Swissmedic. They must supply this person’s contact details to Swissmedic.
Records and all documents created under the vigilance quality management system must be retained for at least 15 years.
Devices are supplied in accordance with their intended purpose and the information provided by the manufacturer.
Devices for self-testing may be supplied only if the dispensing point can guarantee that professional advice is available and that the operational requirements are satisfied. Article 13 of the Federal Act of 15 June 2018 58 on Human Genetic Testing also applies. 59
Dispensing devices for the diagnosis of human communicable diseases to the general public is prohibited. Swissmedic may approve exceptions in the interests of public health.
Claims for devices must only contain statements that correspond to the product information.
Misleading statements, particularly concerning the intended purpose, safety and performance of a device, are prohibited.
Devices intended solely for use by healthcare professionals must not be advertised to the public.
Any professional who uses a device from a foreign country directly without placing it on the market is responsible for the conformity of that device.
Any professional using devices must ensure that the devices are maintained and tested in accordance with the regulations.
Maintenance must be carried out in accordance with the principles of a quality management system, is to be organised appropriately, and must be guided in particular by:
For devices with a measurement function, test procedures may be required in accordance with the Measuring Instruments Ordinance of 15 February 2006 60 .
Swissmedic may issue and publish requirements for maintenance measures. These requirements shall be deemed to constitute the current scientific and technological standards.
Healthcare institutions must put in place all technical and organisational resources required by the state of the art to ensure that network-compatible devices are protected against electronic attack and unauthorised access.
Hospitals must identify, evaluate and document the measures taken under paragraph 1 in accordance with the principles of a risk management system. This system forms an integral part of the hospitals’ quality management system.
Inspections under the auspices of market surveillance shall cover devices made available on the market, conformity assessment procedures, device surveillance, device handling and economic operators’ fulfilment of their obligations. They shall also cover devices made available in contracting states by natural or legal persons domiciled in Switzerland, the conformity assessment procedures and surveillance activities for such devices and the natural or legal persons’ fulfilment of their obligations.
The market surveillance activities undertaken by Swissmedic and the Cantons are governed by Article 66 TPA and Articles 88–90, 92 and 93 EU-IVDR 61 . Article 92 paragraph 3 and Article 93 paragraphs 3 and 4 EU-IVDR are excluded.
The Cantons shall draw up annual plans for their market surveillance activities under paragraph 2. They shall provide Swissmedic with an annual summary of the results of their surveillance activities. Swissmedic may determine both the content of the summary and the form in which it is made available.
Swissmedic is responsible for monitoring:
Certain aspects of the monitoring activities set out in paragraph 1 remain the responsibility of other federal offices or institutions.
The Cantons are responsible for monitoring:
For the purposes of verifying conformity, the authorities responsible for monitoring under Article 69 may, without providing compensation:
If a manufacturer fails to fulfil its obligations under Article 59, Swissmedic may impose appropriate measures to protect health, up to and including prohibiting the making available on the market or the putting into service of the devices in question.
Economic operators that place a device on the market in Switzerland or in a contracting state, and economic operators, professionals and healthcare institutions that make a device available or put it into service in Switzerland or a contracting state have a duty to cooperate on matters of enforcement. In particular, they must provide, free of charge, all necessary information and all necessary proof and documentation to the enforcement bodies.
The providers of information society services also have a duty to cooperate on matters of enforcement. In particular, they should inform the competent authorities about suspected illegal activities by, or information from, users of their service and, upon request, provide information that enables the users of their service with whom they have concluded agreements about storage to be identified.
The provisions of Chapter 10 of MedDO, with the exception of Article 90 MedDO 62 , apply mutatis mutandis to data process by Swissmedic and third parties contracted by Swissmedic.
Swissmedic may publish the following in the medical devices information system:
The FDHA may amend Annexes 1, 2 and 4 to this Ordinance in line with international and technical progress.
Where amendments may pose technical barriers to trade, it shall make them by mutual agreement with the Federal Department of Economic Affairs, Education and Research.
Swissmedic shall provide on its website information on legal acts of the European Commission that, in accordance with this Ordinance, are directly applicable in Switzerland in the version mandatory for the Member States of the EU and as listed in Annex 3.
When implementing this Ordinance, Swissmedic shall respect implementing acts adopted by the European Commission on the basis of EU-IVDR 64 .
Where provided for by international agreements, Swissmedic, the designated bodies, economic operators and the providers of information society services shall cooperate with the European Commission and the authorities of the contracting states.
Swissmedic may appoint experts who are qualified to assess conformity assessment bodies in the field of in vitro diagnostic medical devices.
Swissmedic may appoint experts to participate in expert groups of the European Commission and the authorities of the contracting states.
The customs authorities provide Swissmedic with information on the import, export and transit of devices.
Swissmedic may mandate the customs authorities to detain devices for further inspection and to obtain samples.
It may provide the customs authorities with information about ongoing or concluded administrative or criminal proceedings and sanctions in connection with market surveillance.
Laboratories that wish to be designated an EU reference laboratory by the European Commission according to Article 100 paragraph 1 EU-IVDR 65 may apply to Swissmedic for this designation.
They must demonstrate to Swissmedic in particular that they:
If the requirements are met, Swissmedic shall propose to the European Commission that the laboratory be designated an EU reference laboratory.
The amendment of other legislation is regulated in Annex 5.
Certificates issued before 25 May 2017 under the old legislation retain their validity until the expiry date stated therein, but no longer than 26 May 2025.
Certificates that have been issued since 25 May 2017 under the old legislation, were valid on 26 May 2022 and have not subsequently been revoked shall, following expiry of the period indicated on the certificate, be deemed valid until 31 December 2027.
Certificates that have been issued since 25 May 2017 under the old legislation, were valid on 26 May 2022 and expired before 9 July 2024 shall be deemed valid until 31 December 2027 if any of the following conditions is met:
The following devices may be placed on the market or put into service until the specified dates:
Devices shall not be placed on the market or brought into service in accordance with paragraph 1 unless the following conditions have been met:
The post-market surveillance of devices specified in paragraph 1, their market surveillance, vigilance, registration of economic operators and of the devices themselves are subject to the provisions of this Ordinance.
Devices legally placed on the market prior to 26 May 2022 under the old legislation and devices legally placed on the market in accordance with paragraph 1 from 26 May 2022 may continue to be made available on the market or put into service. 71
… 72
The requirements set out in Article 9 for devices manufactured and used in healthcare institutions apply from the following dates:
The UDI must be affixed in accordance with Article 16 paragraph 2:
If the manufacturer is domiciled in an EU or EEA state or has designated an authorised representative domiciled in an EU or EEA state, that manufacturer must designate an authorised representative in accordance with Article 44 paragraph 1 for all devices placed on the market as from 26 May 2022 within the following time periods:
Conformity assessment body designations issued under Section 4 of MedDO 80 in the version dated 26 November 2017 81 shall become void for in vitro diagnostic medical devices.
A conformity assessment body whose designation has become void in accordance with paragraph 1 and that issued the certificates under the old legislation remains responsible for the appropriate surveillance of all applicable requirements relating to the devices it has certified, unless the manufacturer has agreed with a designated body in accordance with Chapter 4 or a notified body in accordance with EU-IVDR 82 domiciled in an EU or EEA state that this body will carry out the surveillance. 83
The designated body under Article 82 paragraph 1 bis letter f shall be responsible for surveillance of the devices covered by the written agreement from 26 September 2025 at the latest. If the written agreement covers devices intended to replace other devices for which certificates were issued under the under the old legislation, the surveillance shall be carried out in relation to the devices that are being replaced. 84
The arrangements for the transfer of surveillance from the designated body that issued the certificate to a designated body in accordance with Chapter 4 or a notified body in accordance with EU-IVDR domiciled in an EU or EEA state shall be defined in an agreement between the manufacturer and the body that assumes the task of surveillance, and, if possible, the designated body that issued the certificate. The designated body in accordance with Chapter 4 is not responsible for conformity assessment activities that were carried out by the designated body that issued the certificate. 85
A conformity assessment body whose designation has become void in accordance with paragraph 1 and which remains responsible for surveillance in accordance with paragraph 2 shall be subject to supervision by Swissmedic. 86
Conformity assessment body designations issued under Section 4 a of MedDO in the version dated 1 August 2020 87 retain their validity for in vitro diagnostic medical devices.
If an application for designation as a conformity assessment body according to Section 4 a of MedDO in the version dated 26 November 2017 88 was submitted before 26 May 2022, the designation is issued according to the new legislation.
Until Article 16 paragraph 5 enters into force, the notification obligation for manufacturers domiciled in Switzerland according to Article 6 paragraphs 2 and 4 MedDO 89 in the version dated 26 November 2017 90 continue to apply.
... 91
The notification obligation according to Article 10 for devices manufactured and used in healthcare institutions applies from the following dates:
Subject to the exceptions in paragraph 2, this Ordinance enters into force on 26 May 2022.
Article 16 paragraph 5 and Article 90 paragraph 2 enters into force at a later date.
(Art. 5 para. 1)
The terms listed below and used in EU-IVDR 92 and this Ordinance are equivalent as follows:
EU | Switzerland |
|---|---|
a. English terms | |
Union | Switzerland |
Member State | Switzerland |
Third country | Other state |
Union market | Swiss market |
Union legislation / | Legislation |
Harmonised standard | Designated standard |
State of the art | Scientific and technological standards |
EU declaration of conformity | Declaration of conformity |
Official Journal of the European Union | Federal Gazette (Bundesblatt) |
Established outside / within the Union | Domiciled in / outside Switzerland |
Authority | Competent authority under Swiss law |
a. Deutsche Ausdrücke | |
Union | Schweiz |
Mitgliedstaat | Schweiz |
Drittstaat / Drittland | anderer Staat |
Unionsmarkt | Schweizer Markt |
Rechtsvorschriften der Union / | Rechtsvorschriften |
Harmonisierte Norm | Bezeichnete Norm |
Stand der Technik | Stand von Wissenschaft und Technik |
EU-Konformitätserklärung | Konformitätserklärung |
Amtsblatt der Europäischen Union | Bundesblatt |
Ausserhalb / In der Union ansässig | Sitz ausserhalb / in der Schweiz |
Behörde | Nach schweizerischem Recht zuständige Behörde |
Angehörige der Gesundheitsberufe | Gesundheitsfachpersonen |
Aussetzung | Suspendierung |
b. French terms | |
Union | Suisse |
État membre | Suisse |
État tiers / pays tiers | autre État |
marché de l’Union | marché suisse |
législation (actes législatifs) de l’Union / | législations |
norme harmonisée | norme désignée |
état de l’art | état de la science et de la technique |
déclaration de conformité UE | déclaration de conformité |
Journal officiel de l’Union européenne | Feuille fédérale |
situé hors de l’Union / établi dans l’Union | sis à l’étranger / en Suisse |
notice d’utilisation | mode d’emploi |
conditionnement | emballage |
notification des incidents graves | déclaration des incidents graves |
autorités | autorités compétentes en vertu du droit suisse |
retrait des certificats | révocation des certificats |
retrait de la désignation | révocation de la désignation |
c. Italian terms | |
Unione | Svizzera |
Stato Membro | Svizzera |
paese terzo | altro Stato |
mercato dell’Unione | mercato svizzero |
legislativo dell’Unione / | legislazioni |
norma armonizzata | norma designata |
stato dell’arte | stato della scienza e della tecnica |
dichiarazione di conformità UE | dichiarazione di conformità |
marcatura CE di conformità | marchio di conformità |
Gazzetta ufficiale dell’Unione europea | Foglio federale |
avente sede fuori dall’Unione,/ stabilito nell’Unione | avente sede all’estero/ in Svizzera |
autorità | autorità competente secondo il diritto svizzero |
operatori sanitari | professionisti della salute |
controllata | società controllata |
ritiro dei certificati | revoca dei certificati |
ritiro della designazione | revoca della designazione |
immissione sul mercato | immissione in commercio |
segnalazione di incidenti gravi | notifica di incidenti gravi |
confezionamento | imballaggio |
(Art. 5 para. 2)
Where this Ordinance makes reference to provisions of EU-IVDR94 that in turn make reference to EU law, the versions below remain applicable:
Where this Ordinance makes reference to provisions of EU-IVDR that in turn make reference to EU law, the Swiss law below is applicable in place of the EU law:
EU law |
|
|---|---|
1. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, OJ L 311 of 28.11.2001, p. 67 |
|
2. Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, OJ L 136 of 30.4.2004, p. 1 |
|
3. Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products, OJ L 210 of 7.8.1985, p. 29 |
|
4. Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to electromagnetic compatibility, OJ L 96 of 29.3.2001, p. 79 |
|
5. Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC, OJ L 157 of 09.06.2006, p. 24 |
|
6. Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council, OJ L 316 of 14.11.2021, p. 12 |
|
7. Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data, OJ L 8 of 12.1.2001, p. 1 |
|
8. Regulation (EC) No. 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93, OJ L 218 of 13.8.2008, p. 30 |
|
9. Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC, OJ L 396, 30.12.2006, p. 1 |
|
10. Council Directive 80/181/EEC of 20 December 1979 on the approximation of the laws of the Member States relating to units of measurement and on the repeal of Directive 71/354/EEC, OJ L 39 of 15.2.1980, p. 40 |
|
11. Council Directive 2013/59/Euratom of 5 December 2013 laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation, and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and 2003/122/Euratom, OJ L 13 of 17.1.2014, p. 1 |
|
12. Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices, OJ L 189 of 20.7.1990, p. 17 |
|
13. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, OJ L 169 of 12.7.1993, p. 1 |
|
14. Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, OJ L 331 of 7.12.1998, p. 1. |
|
15. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC, OJ L117 of 5.5. 2017, p. 1. |
|
(Art. 16 para. 4, 21 para. 3, 25 para. 2, 38 para. 2, 40 para. 1 and 58)
For the purposes of implementing this Ordinance, the legal acts adopted on the basis of the provisions of EU-IVDR 106 set out below apply in Switzerland in the binding version applicable to the EU Member States:
Subject matter | Passed by the European Commission based on the EU-IVDR |
|---|---|
Art. 16 para. 4 IvDO | Delegated acts in accordance with Art. 24 para. 10 EU-IVDR |
Art. 21 para. 3 IvDO | Delegated acts in accordance with Art. 51 para. 6 EU-IVDR |
Art. 25 para. 2 IvDO | Delegated acts in accordance with Art. 17 para. 4 EU-IVDR |
Art. 38 para. 2 IvDO | Delegated acts in accordance with Art. 40 para. 11 EU-IVDR |
Art. 40 para. 1 IvDO | Delegated acts in accordance with Art. 10 para. 4 EU-IVDR |
Art. 58 IvDO | Implementing act in accordance with Art. 24 para. 11 let. a EU-IVDR |
(Art. 12 para. 1)
The conformity marking is as follows:
Where a designated body has to be involved, its identification number is to be placed beside its conformity marking:
(Art. 80)
The legislation below is amended as follows:
… 107