Impact of Medical Device Regualtions (MDR) Postponement on Swiss Medtech Industry
On 17 April 2020 the European Parliament decided to postpone the transition timeline to implement the EU Medical Device Regulation (MDR), which was set to expire on 26 May 2020, until 26 May 2021. The EU MDR postponement was published in the Official Journal of the European Union and entered into force on 24 April 2020.
The postponement allows EU healthcare systems to devote their efforts to the fight against the COVID-19 pandemic and takes the pressure off national authorities, notified bodies, manufacturers and other industry players.
Although there has been no official statement from the European Union, the competent Swiss authorities consider it as granted that the status quo regarding medical devices continues to apply to Switzerland. The Federal Office of Public Health (FOPH) and the State Secretariat for Economic Affairs (SECO) have confirmed the following presumed impact of the MDR's postponement on the Swiss medtech industry:
- the extended implementation timeline also applies to Switzerland, as a result of which medical devices may be placed on the EU internal market until 25 May 2021 under the current EU and Swiss legal framework; and
- the current legal framework also includes the current mutual recognition agreement (MRA) between Switzerland and the European Union. Thus, the provisions in Chapter 4 of the MRA for medical devices will continue to apply beyond the stipulated application date of 25 May 2020, until 25 May 2021.
Consequently, medical devices can still be placed on the EU internal market until 25 May 2021 as before (ie, without having to meet EU requirements). Therefore, according to the FOPH, the revised Swiss medical device legislation's entry into force (eg, the Therapeutic Products Act, the Human Research Act and related ordinances) has also been postponed for one year to maintain equivalence with the EU law.
The SECO has stated that the adaption of the MRA between Switzerland and the European Union was their highest priority. However, Swiss Medtech recommends Swiss companies to consider that the MRA might not be updated within one year. Should this be the case, all medical devices would have to meet the EU requirements in one year at the latest to continually and successfully be placed on the EU internal market.
According to a survey initiated by Swiss Medtech in March 2020, most Swiss medtech industry actors consider it feasible to be compliant with EU requirements by May 2021.
For further information on this topic please contact Andreas Wildi or Monja Sieber at Walder Wyss by telephone (+41 58 658 20 00) or email ([email protected] or [email protected]). The Walder Wyss website can be accessed at www.walderwyss.com.