• Introduction to GS1 as Issuing Agency
• Implementation of GS1 standards for Medical Devices. How to verify that the UDI-DI and B-UDI are valid? Latest information on Master UDI-DI.
• GS1 Belgium & Luxembourg solution to publish B-UDI and UDI-DI to the EUDAMED module Devices

Set aside the never-ending implementation of EU Regulations, the former single market of CE marking has been facing major upheavals. Political decisions shaped a new regulatory landscape from the mountains (Switzerland – SWIXIT) to the shore (United Kingdom – BREXIT) in which all actors must react quickly to ensure continuous compliance. Being the written proof for compliance the technical documentation has to reflect such changes and new (local) requirements. As such the “Exit” dates of the United Kingdom and Switzerland harboured the risk for a significant impact on the availability of the devices.

Considering this and the input from the market, the regulators saw reason and granted transition periods or, even better, (temporarily) aligned the National requirements with the EU Regulations. But because the devil is in the detail a thorough study of the UK/CH legislations and gap analysis is mandatory to identify required adjustments within the existing technical documentation.

We will deep-dive into the legal background of the technical documentation “synergy alignment” between the EU, UK and CH. Gaps and hallmarks of the legislations will be identified and transition deadlines learned.

The audience will be able to

• tell the applicable timelines and transition dates for acceptance of the CE marking in the UK and CH.
• adapt UK/CH specific requirements to their existing technical documentations and to know the applicable references in the legislations.
• understand the obligations of the EU/CH Authorised Representatives and UK Responsible Person regarding the technical documentation.

Switzerland became a third country to the EU on 26 May 2021 when the Medical Devise Regulation (MDR) came into force and the Swiss-EU Mutual Recognition Agreement (MRA) failed to be updated. Since then, all Swiss manufacturers must establish an authorised representative in the EU (EC-REP), and in return all foreign manufacturers need a Swiss authorised representative (CH-REP). The associated cost amounts to around 3% of the turnover.

More worryingly, a quarter of the foreign manufacturers (1200 out of 5000 companies) decided not to establish a CH-REP and to stop trading. As a result, 15% of the imported medical devices (60’000 of 400’000 products) are no longer available to Swiss patients.

Under the MDR, a further reduction of the portfolio looms and innovation is decreasing all over Europe. This is a bad development, also recognized by the Swiss parliament. In November 2022, it instructed the government to create the legal conditions to recognise medical devices from non-European regulatory systems in Switzerland, for example those authorised by the FDA.

After becoming a third country to the EU, Switzerland had to decide to find its own path. What will the future hold for the Swiss medtech industry and for Swiss patients?