1. The background in a nutshell
• Until 25th May 2021 all Medtech products that are admitted in Switzerland for the sale can be distributed also in the EU.
• However, currently a new treaty is negotiated by Switzerland and the EU Joint Committee in that regard.
• In case the treaty is not going to be concluded between Switzerland and the EU, all Medtech companies based in Switzerland are considered as not being anymore part of the EU. Indeed this treaty hangs by a hair.
Following the latest developments of the poIiticaI Swiss-EU negotiations concerning the Institutional Agreement and the Mutual Recognition Agreement (MRA), Swiss Medtech companies should be preparing for the case in which MRA would no longer apply to the medical devices after 26th May 2021.
2. What does it mean for Swiss established Medtech companies?
Implications for Medtech companies, in case the treaty is not going to be concluded:
• Swiss established Medtech companies are not considered anymore as part of the EU, when placing their products in the EU.
• Therefore, for the distribution of the Medtech products the following three main requirements should be considered:
1. Appointment of a new EU resp. EEA representative (e.g. a group company, a third party distributor or an importer)
2. Appointment of a new importer of record (for regulatory purposes)
3. Amendment of the product labelling including the new representative. The open key question is whether or not the Medtech products will have to be sold to the importer of record; leading to substantial supply chain changes and tax implications.
Furthermore ,the new regulations define the implementation of a European centralised database by the regulatory authorities where all relevant data related to the sale of Medtech products have to be filed electronically.
This leads to an increased transparency – also for tax relevant data of the supply chain.
3. Recommendation & next steps
We recommend to:
• Be prepared for the possible changes related to the appointment of a new EU resp. EEA representative and importer of record as well as to the amendment of labelling
• Be prepared for the increased transparency of your data related to the set up of the new centralised database
• Start drafting a respective agreement between your company and your representative in the EU resp. EEA
• To outline a tailored back up scenario that suits the strategy of your company.
We would be happy to exchange with you about the latest developments as well as on the strategies/ tendencies we are observing at the market.
Dr. Sandra Ragaz, Partner
Leader Pharma & Life Science Regulatory / VAT Switzerland
Tel.: +41 58 792 44 69
Mobile.: +41 79 792 72 98