Objective:

To compare the measures taken by the European Union, Switzerland and the United Kingdom to ensure the continuity of the medical devices market, complying with the requirements of Regulation 2017/745.

Method:

To carry out this work, a review was made of the official websites of the European Commission, the Spanish Agency for Medicines and Health Products, the Swiss Agency for Therapeutic Products and the Medicines and Healthcare Products Regulatory Agency of the United Kingdom. Bibliographic searches were also conducted on Pubmed and the internet (Google), using terms such as “withdrawal of the Mutual Recognition Agreement of Swiss European Union medical device conformity certificates, new UK medical device regulation”, for a period extending from January 2020 to December 2021.

Results:

As a result of the disappearance of the legal framework that supported free trade between Switzerland, the United Kingdom and the European Union, products that used to be unrestrictedly distributed in Europe have become imports having to comply with the relevant legal requirements. Distributors for their part have become importers, and declarations of conformity and CE certificates have lost their validity. Furthermore, notified bodies from Switzerland and the United Kingdom are no longer recognized by the European Commission. Switzerland, the United Kingdom and the European Union have had to grant grace periods to allow regulatory agencies and economic operators to adapt to the new situation.

Conclusions:

The transition period toward the new economic scenario has not yet ended. Both Switzerland and the United Kingdom have had to take stronger measures than the EU to adapt to the changes. Both Switzerland and the United Kingdom are expected to finally incorporate the requirements of the new Regulation in their internal legal systems.