The end of the MDR transition period is rapidly approaching (26/05/2020), bringing lots of uncertainties for the medical device industry. Next to challenges and uncertainties on how to implement the new requirements and how to get products certified on time, Swiss manufacturers are facing another challenge. Will they become a "Third Country" under the MDR or not?
What's the current situation?
The economic relations between Switzerland and the European Union are guided by a series of bilateral treaties where Switzerland has adopted several European Union laws in order to participate in the Union’s single market, without being a member state.
The trade of medical devices is covered by a Mutual Recognition Agreement (MRA) between the EU and Switzerland.
This agreement refers specifically tot he 93/42/EEC Medical Device Directive.
For now, all is ok, but soon there won’t be a Medical Device Directive anymore and there is currently no update of the MRA…
What will happen on May 26th 2020?
If there is no updated MRA that includes reference to the 2017/745 Medical Device Directive before the end of the transition period, Switzerland will fall under the Third Country category.
Being a Third Country implies that Swiss manufacturers will need to meet the requirements of countries outside of the European Union that want to place products on the European market.
This news is not falling from the sky. The Swiss MedTech association has been reporting on the progress (or lack thereof) on several occasions.
Their latest communication in January 2020 about this topic confirms that currently there is still no change in the situation which means that the “worst case scenario” for Swiss manufacturers becomes more and more realistic.
What should Swiss manufacturers do?
Swiss manufacturers should anticipate the worst case scenario and start preparing.
- Start looking for importers/EC representative
- Update contracts including MDR requirements (e.g. EC representative, importer, etc)
- Start preparing updated packaging (including information about their EC representative, etc)
- Make sure to include all obligations in their QMS (e.g. contracts with EC representative, communication flow in case of field safety corrective actions, etc)
Some last minute political decisions could change the situation for Swiss manufacturers, so it’s key to keep monitoring the news about this topic!!
Being a Third Country or not is only one of the many challenges Swiss manufacturers (and other manufacturers) are facing. We regularly monitor the news and provide updates related to MDR preparations.