MedTech products: Swiss industry under pressure
From 26 May, new approval rules for medtech products will apply in the EU. By then, the bilateral agreement on the recognition of conformity rules must be updated. Otherwise, existing products will also have to be re-approved in the EU, according to media reports.
On 26 May, new rules for the approval of numerous medtech products will come into force in the EU. If the Joint Committee has not incorporated these rules into the 1999 agreement by then, Switzerland will become a normal third country in this area. Then it may not only be the new medtech products from Switzerland that have to be approved a second time in the EU.
The Swiss medtech industry could be hit by the deadlock in relations between Switzerland and the EU. The EU refuses to update existing bilateral agreements. This affects in particular the Agreement on mutual recognition in relation to conformity assessment one of the seven Bilateral I agreements. This regulates which regulations are recognised as equivalent in the EU and Switzerland.
New regulations must be incorporated into the agreement by a joint committee of both sides. This was last done in 2017.
Rather, according to a Report the "Neue Zürcher Zeitung", it is possible that existing products for which Swiss approval was previously sufficient will also be re-approved in the EU. This means that seven times more products would be affected by the blockade than previously assumed. In addition, Swiss companies would have to appoint an authorised representative in the EU to take responsibility for the products.
The EU has considerable leeway in deciding how the Swiss medtech industry will be treated. "One possible interpretation assumes that in a transitional phase until 2024, even new products must continue to be recognised," Peter Studer, at industry association Swiss Medtech responsible for regulation, in a Report of the "Tages-Anzeiger". But the uncertainty is weighing on the industry.
The institutional framework agreement, which is at the heart of the bilateral blockade, remains on shaky ground.
