Switzerland's Medical Device Export Recovery Facing Threat From EU's Medical Device Regulation Implementation

摘要

Switzerland's medical device manufacturers and distributors face short-term risks associated with the implementation of EU Medical Device Regulation (MDR) in May 2021. The EU has still not provided a Mutual Recognition Agreement for Switzerland's new Medical Devices Ordinances. Switzerland is a net exporter of medical devices and will face hurdles if the country is to become a 'third country'to the EU. This would require swiss companies to appoint an importer and an authorised representative in a member state to continue to supply medical devices to the EU. Following the Covid-19 pandemic, the recovery of Swiss medical device exports, and particularly its orthopaedics market, faces a number of risks. In addition to regulatory issues with the EU MDR, a number of key export markets are experiencing a third wave of Covid-19. Further lockdowns across mainland Europe represent a downside risk to our forecast of resurgent demand in 2021.