EU IVDR v. CH IvDO: How are In Vitro Diagnostic Medical Devices regulated on the Swiss market?

The end of the Mutual Recognition Agreement

On May 26, 2022, the new Regulation 2017/746 (IVDR) repealed Directive 98/79/EC on in-vitro diagnostic devices (IVDD), which was part of the Mutual Recognition Agreement between the EU and Switzerland. Due to the absence of a renewal of the MRA, Switzerland lost its special status and became a “third country”. This meant that a separate regulatory framework started being applicable in Switzerland for IVDs as of May 26, 2022.

Swiss In Vitro Diagnostic Medical Devices Ordinance (CH IvDO)

As of the same date of application of the IVDR, May 26, 2022, Switzerland enacted its new In-vitro Diagnostic Medical Device Ordinance (IvDO). The IvDO contains 91 Articles and 5 Annexes and, although regulating IVDs on the Swiss market solely, it is mainly aligned and refers to many provisions of the EU IVDR.

Among the most striking differences, it is worth underlining that the IvDO laid down the requirements for Swiss Authorised Representatives and CH AR, Swiss Importers and Swiss economic operators registration. Further details on all the IVD Ordinance (IvDO) deadlines are available here.

We present here an overview of changes and similarities between the two legislations:

• Swiss In Vitro Diagnostic Medical Devices Ordinance (CH IvDO)
• Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR)

Similarities

As previously mentioned, many provisions of the Swiss law are aligned with the EU IVDR. Below, we list some examples of provisions identical or very similar:

• Classification as per Annex VIII to EU-IVDR;
• Conformity assessment routes as per Annex V to EU-IVDR;
• General obligations of manufacturers as per Art. 10 of EU IVDR with addition of provisions on Technical Documentation in accordance Annexes II and III to EU-IVDR:
  • Performance evaluation in accordance with Article 56 and Annex XIII to EU-IVDR
  • Document retention as in the EU IVDR (10 years from last placing on the market),
  • Appointment of PRRC (deputy PRRC is explicitly mentioned in the CH IvDO)
  • Affixing of conformity marking (However, not only CE marking is recognized in Switzerland!);
• General Safety and Performance Requirements listed in Annex I to EU-IVDR;
• Declaration of Conformity as per Annex IV of EU IVDR (However, it must be written or translated in one of the three official languages of Switzerland or in English language!);
• Provisions on Authorised Representative (except the option to transfer the technical documentation to the Swiss Authority in case of an agreement with the manufacturer);
• PRRC qualifications;
• Distance sales (e-commerce);
• Post-market surveillance system and related obligations (drawing up of a Plan, Report for class A, B and Safety Report for class C, D) & Summary of Safety and Performance (SSP) for Class C and D);
• Vigilance & Trend reporting;
• UDI storing & affixing;
• Assignment of Basic UDI-DI;
• Labelling & Misleading claims, for ex. importer shall appear on the label and, for devices for self-testing or for near-patient testing, the information stated in Chapter III of Annex I to EU-IVDR should be easily understandable (furthermore, it must be written in the three official languages of CH!); See below for more information on labelling.
• Transitional provisions: same as EU IVDR progressive rollout;
• Certificates issued by Notified Bodies before May 26, 2022 remain valid until their expiry date, but no longer than May 26, 2025;
• Legacy devices and sell-off provision are regulated as in the EU:
  • Class D products may continue to be placed on the market or put into service until May 26, 2025 and can be made available or put into service until May 26, 2026.
  • Class C products may continue to be placed on the market or put into service until May 26, 2026 and can be made available or put into service until May 26, 2027.
  • Class B products may continue to be placed on the market or put into service until May 26, 2027 and can be made available or put into service until May 26, 2028.
  • Class A devices placed on the market in a sterile condition may continue to be placed on the market or put into service until May 26, 2027 and can be made available or put into service until May 26, 2028.

• UDI carrier on the label, same deadlines apply in the EU:
  • Class D from May 26, 2023;
  • Class C and B devices: from May 26, 2025;
  • Class A devices: from May 26, 2027.

Therefore, on the aspect mentioned above, compliance for manufacturers wishing to sell both on the EU and CH market is very similar.

Differences

However, there are some differences between the EU and CH framework on medical devices that are worth mentioning:

• Registration of Swiss-based manufacturers, AR, importers to obtain a CHRN – Swiss Unique identification number;
• Deadline to register Swiss economic operators of:
  • IVDR compliant devices placed on the market for the first time after 26 May 2022: within 3 months.
  • IVDR compliant devices that have been placed on the market prior to 26 May 2022: by 26 November 2022.
  • IVDD compliant devices placed on the market for the first time after 26 May 2022: within three months.
  • IVDD compliant devices that have been placed on the market prior to 26 May 2022: no obligation to register.

• Device notification is to be performed to Swissmedic and not to EUDAMED:

Manufacturers domiciled in Switzerland are obliged to notify Swissmedic when they place IVDs on the market in Switzerland for the first time.

Non-Swiss manufacturers and their Swiss CH-REP are not obligated to notify IVDs to Swissmedic. This might change in future, as Switzerland is building its own database Currently, Switzerland does not have access to EUDAMED, as other EU Member States.

• Vigilance for non-Swiss manufacturers is a responsibility of the Swiss Authorised Representative (CH-REP);
• Designated body in CH v. Notified Body in the EU;
• Conformity marking: both “MD’’ and CE marking are recognized and it shall appear on the device, on the instructions for use and trade packaging;
• Advertising:
  • Claims for products 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 professionals must not be advertised to the public.

• Appointment of CH Authorised Representative: any non-Swiss based manufacturer shall appoint a CH-REP by:
  • manufacturers already on the market:

• • • Class D         →    December 31, 2022
    • Class C & B  →    March 31, 2023
    • Class A         →    July 31, 2023
  • Manufacturers entering the Swiss market after May 26, 2022 → immediately.

• Swissmedic is responsible for market surveillance;
• Device maintenance: Swissmedic can issue and publish requirements for maintenance measures;
• Swissmedic will respect the implementing acts adopted by the European Commission on the basis of EU IVDR when implementing the CH law;
• The obligation to appoint a deputy PRRC is explicitly mentioned (while a backup PRRC is not specifically listed in the MDR).

Finally, some important elements related to language and local requirements on the Swiss market:

• Labels & IFUs accompanying the device shall be translated in the three official languages of Switzerland or in English, provided that:

1. • The device is supplied exclusively to professionals or is a custom-made device or a medical device manufactured and used in a healthcare institution;
   • The user meets the necessary professional and linguistic requirements and qualifications, and agrees to receive labels and IFUs in English;
   • The protection of patients, users and third parties is ensured;
   • The efficacy and performance of the medical device are not placed at risk.

If requested, additional information must be provided to users in one of the official languages of Switzerland.

• Deadlines to list Swiss Authorized Representative on the label:

• • IVDR compliant devices not for self-testing
    • On the label or in a document accompanying the device: until March 31, 2025
    • On the label: after March 31, 2025
  • IVDR compliant devices for self-testing:
    • On the label: From May 26, 2022, if already on the market, see below paragraph for the deadlines
  • IVDD devices that have already been placed on the EU/Swiss market by the EU manufacturer or with an EU-based Authorised Representative:

• • • On the label, on the external packaging, in the IFU or in a document accompanying the device by:
      • Class D: December 31, 2022;
      • Classes C and B: March 31, 2023;
      • Class A: July 31, 2023

• • IVDD devices without EU manufacturer or EU-based Authorised Representative:

• • • On the label, on the outer packaging, or in the instructions for use from 26 May 2022.

More specifically, Art. 105 which set the temporary provisions has been entirely repealed:

• Until IvDO entered into force, in vitro diagnostic medical devices were subject to the Medical Devices Ordinance of 17 October 2001, subject to paragraphs 2 and 3.
• IVDs must not carry the name and address of the natural or legal person who first places them on the Swiss market on their labelling, outer packaging or instructions for use if they carry the name and address of the natural or legal person who places them on the market in an EU or EEA state.
• IVDs already notified to the competent authority of an EU or EEA state in accordance with Article 6 paragraph 2 of the Medical Devices Ordinance of 17 October 2001 did not have to be additionally notified to Swissmedic.

While for Art. 107, only paragraph 4 which ruled that until IvDO entered into force, the conformity assessment bodies for IVDs could continue to be designated in accordance with Section 4 and 4a of the Medical Devices Ordinance of 17 October 2001, has been repealed.

Further additional amendments were included with respect to medical devices as well; for example, in Art. 2 concerning exceptions, paragraph J was added to specify that MedDO does not apply to combinations which, when placed on the market or put into service, incorporate as an integral part transplant products in addition to the device (although the part of the combination that is deemed to be a device must satisfy the general safety and performance requirements set out in Article 6).

In Art. 3, paragraph 3.b was included to specify that “accessory for a medical device” can also mean an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or more particular medical devices and which specifically and directly assists the medical functionality of the medical device(s) in terms of its/their intended purpose(s).

Do you want to know all the implications of the new Swiss IVD Ordinance? Are you a non-Swiss based manufacturer? Contact us to direct you towards the relevant departments of Obelis CH, your future professional Authorised Representative for the Swiss market!

 

References:

Fedlex. (2022). Ordinanza relativa ai dispositivi medico-diagnostici in vitro (ODIV) del 4 maggio 2022 (Stato 26  maggio 2022) – RU 2022 291. Retrieved on 24/06/2022 from https://fedlex.data.admin.ch/eli/cc/2022/291

European Commission. (2022). Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU. Retrieved on 24/06/2022 from https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0746&from=EN

Swissmedic. (2022). Information sheet on obligations for authorised representatives, importers and distributors. Retrieved on 24/06/2022 from https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/mu600_00_016d_mb_pflichten_wirtschaftsakteure_ch.pdf.download.pdf/MU600_00_016e_MB_Obligations_Economic_Operators_CH.pdf