ZOLL and the medical device regulation
The new regulation by the European Union was brought about to ensure and increase patient safety
On March 20th, 2023, the EU published in their official journal on Regulation (EU) 2023/607 amending MDR, the information of an extension of the transition phase for medical devices. Under this new timeframe, class III and implantable devices of class IIb will be able to continue to be marketed under their MDD certifications through 31 December 2027*, while class IIb, IIa and class I devices that require an external conformity assessment will have an extension until December 2028*. The extension will be subject to certain conditions, so that only devices that are safe and for which manufacturers have already taken steps to transition to the rules provided for by the Medical Devices Regulation will benefit from the additional time.
UK market specific regulations and transitional phase
As the UK left the European Union, the UK government is not following the EU Medical Device Regulation. The MHRA (Medicines & Healthcare products Regulatory Agency) continues to work on the development of specific regulations for the UK market, aiming for core aspects of the future regime for medical devices to apply from 1 July 2025. Transitional periods for CE mark acceptance under EU regulations are in place, to allow medical devices still being placed into UK markets under certain conditions. Please visit the UK government website for more detailed information or stay tuned on further ZOLL communication: https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk
What does this mean for you and for ZOLL?
Our experienced regulatory team is already working on putting the necessary project teams in place to ensure a prompt transition of our products' CE marking from MDD to MDR with regards to the European Union. In 2020, we received recertification of CE marked products under the MDD, currently valid until 26 May 2024. ZOLL Medical Corporation continues to closely monitor the changes impacting the EU market and is working to ensure continued compliance. All ZOLL devices that will be continued under MDR regulations are currently fulfilling the conditions for the extension period to be marketed until 2027 or 2028, as applicable.
In addition, ZOLL is following closely the developments on the new UK regulations, and is taking all necessary steps to maintain availability of products during and after the transitional phases.
ZOLL has a proven record of successful product certifications and registrations around the world. In 2018, ZOLL was the first company to receive premarket approval from the FDA in the U.S. on its full portfolio of defibrillators. With our experience in manufacturing safe medical devices for 40 years, we are working towards meeting the new MDR requirements.
*if covered by a certificate or a declaration of conformity issued before 26 May 2021 that has not expired or been withdrawn