MDR approaching, what to consider in the short term (until 25.5.)
There are only a few days left until the Medical Device Regulation MDR comes into force on May 26, 2021. To date, no agreement has been reached between Switzerland and the EU regarding the framework agreement. The attitude of the EU is well known: if the Framework Agreement (InstA) is not concluded, the MRA will not be renewed and without MRA the equivalence of Swiss laws and regulations (TPA, MedDO, ...) with European law is no longer given. Without MRA, Switzerland will put into force a contingent MedDO as of 26.5.2021 (MDR requirements without European networking elements).
Even though discussions are still taking place at the moment, we have to assume that as of 26.5.2021 Switzerland will be fully considered as a third country by the EU with regard to medical device regulation. This treaty-less state will have central consequences for manufacturers in Switzerland and Europe.
We would like to briefly explain these in this newsletter.
We would therefore like to urgently draw your attention once again to the following points:
Manufacturers based in Switzerland
- Manufacturers based in Switzerland will need to appoint an authorized representative in the EU area.
- Make sure you notify the EU authorized representative to your Notified Body.
- Make sure that the labeling (e.g. label, DoC etc.) is adapted accordingly.
Especially for manufacturers of Class I devices there is a need for action:
- Class I devices must comply with all provisions of the MDR (labeling, TD, etc.) as of May 26, 2021. To avoid a supply stop as of 26.5 to the EU, make sure that all Class I products are notified by the EU Authorized Representative to the competent authority in the EU area before 26.5.
Manufacturers of up-classified products (e.g. Class I software, Ir, certain substance based MD).
- Products that fall under MDD in Class I but are classified higher according to MDR are the exception. The second corrigendum of the MDR allows these products a transition period under certain conditions. In order to make use of this transition period, these products must also be notified by the EU Authorized Representative to the competent authority before May 26. We therefore recommend that all affected manufacturers appoint an EU Authorized Representative before May 26 and ensure that the products are notified to the EU before May 26.
The following MDCG document lists the requirements for these products: MDCG 2020-2 rev. 1 Class I Transitional provisions under Article 120 (3 and 4) – (MDR)
Manufacturers based in the EU
- Manufacturers based in Europe will have to appoint a Swiss Authorized Representative (SAR, Swiss-Rep). It is expected that there will be a transition period for the Swiss-Rep.
- Nevertheless, make sure at an early stage that you as a manufacturer have a Swiss authorized representative as well as an importer and initiate the corresponding processes (labeling, etc.).
- More information also at swiss-rep.ch
We are still hoping for generous transition periods, but there is no reliable information on this yet.
The situation is complex and at times confusing. We will do our best to support you and provide you with up-to-date information.
All the best and kind regards