Switzerland is going to amend its current medical device regulations in response to the changes implemented by Regulation 2017/745 (MDR).
Mutual Recognition Agreement
A mutual recognition agreement in the area of conformity assessment (MRA) is the most important document to establish the principles necessary to connect Swiss and EU markets. MRA’s are intended to reduce time and costs associated with the access to foreign markets for numerous categories of industrial goods including medical devices.
The MRA is based on the following approaches:
- Harmonization of regulatory requirements and applicable standards to make it easier for medical device manufacturers to comply with,
- Recognition of conformity assessments performed by another party as long as there is no need to perform it twice.
This agreement specifies that the bodies authorized by the parties to issue certificates would be mutually recognized.
It is also important to mention that due to the effective harmonization attempts, most of the regulations in Switzerland and the EU are so similar that certificates issued in accordance with Swiss requirements often allow the marketing of the device in the EU. In the main part, the agreement contains general rules that apply to all categories of industrial products falling within the scope of the regulation. It also covers the two annexes: one providing specific rules for certain categories of products, and another one regulating the designation of assessment bodies entitled to issue mutually recognized certificates. In accordance with Chapter 4 of the MRA Annex 2, which is dedicated to medical devices, the assessment body intended to be designated should comply with the appropriate requirements set forth in the Regulation 2017/745 (MDR) and the Regulation 2017/746 (IVDR).
Chapter 4 of the aforementioned document also includes a set of rules, including:
- There is no need to appoint a special representative responsible for communications with regulating authorities and post-marketing surveillance on the territory of another party in order to market medical devices. It is enough to duly inform the actual principal place of business and the contact person responsible for such issues.
- Following the previous rule, there is no need to provide information about the authorized representative at the labeling of medical devices. Similarly, the aforementioned information should be indicated for all medical devices imported from third countries.
MDR Implementation in Switzerland
Existing provisions of the MRA establish close cooperation between regulating authorities in Switzerland and the EU. For example, the European Commission, the EU regulating authority for medical device circulation, should be duly informed on all designations of expert laboratories. The Swiss authorities will also have access to the European medical device databases and will provide the information that should be submitted to the databases to the appropriate EU bodies to upload such information for them.
According to the existing regulations, the provisions set forth by the MDR should be implemented and put into force in Switzerland from the date the Regulation 2017/745 takes effect.
Summarizing the information provided above it is possible to conclude that:
- Medical devices that comply with the requirements set forth by the Regulation 2017/745 (MDR) or Regulation 2017/746 (IVDR) could be offered at both EU and Swiss markets without any additional approval or registration,
- Any and all certificates and other documents issued by the assessment bodies designated under the Regulation 2017/745 (MDR) or Regulation 2017/746 (IVDR) would be mutually recognized in both Switzerland and the EU.
At the same time, the described framework provided by the current version of the MRA could be subject to changes so the regulatory uncertainty still remains. The export of medical devices constitutes a substantial share of the overall Swiss export.
MRA And Potential Implementation Issues
A group of stakeholders, including lawyers specializing in the appropriate areas and the representatives of medical device manufacturers’ associations, initiated discussion of the issues related to the implementation of the new Regulations within the scope of the MRA. If certain medical devices fall outside the scope of the revised version of the MRA, the general rules for third countries will apply. This means that Swiss medical device manufacturers would have to appoint local representatives in the EU to apply for conformity assessment performed by the EU-based designated notified body, similarly to the manufacturers from other non-EU countries. It is also important to mention that all delays in the process of EU MDR implementation, such as Second Corrigendum, for example, do not affect requirements that apply to third parties.
To provide medical device manufacturers with more details regarding the issues associated with the MRA, Swiss Medtech, the Swiss association of medical device manufacturers, issued a brief information notice dedicated to the most important regulatory issues. The association describes three possible scenarios that could take place in the future:
- Favorable scenario – all medical devices would be covered by the MRA,
- Moderate scenario – medical devices subject to the MDR would be excluded from the scope of the MRA while older certificates issued under the Medical Devices Directive 93/42/EEC (MDD) would remain valid,
- Unfavorable scenario – all medical devices would be excluded from the scope of the MRA and Swiss manufacturers would have to comply with third country rules.
The association informs that there were certain cases where the EU notified bodies required Swiss manufacturers to comply with third country requirements. Thus, the association advises medical device manufacturers to be prepared for the moderate scenario and to appoint authorized representatives in the EU countries.
The Swiss Medtech also warns that according to the information available, certain members of the European Commission are going to support the unfavorable scenario providing total exclusion of medical devices from the scope of the MRA.
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