In response to the challenges medical device manufacturers face during the transition from the EU Medical Device Directive (MDD) to the Medical Device Regulation (MDR), the European Commission has finalized an extension to the transition period.
This extension, introduced through Regulation 2023/607, offers crucial breathing space for manufacturers, ensuring a smoother transition and an uninterrupted supply of medical devices in the EU market.
The original full application date of the EU MDR was postponed from 26th May 2021 to 26th May 2022 due to the COVID-19 pandemic. However, the deadline of 26th May 2024 for placing ‘legacy’ medical devices on the market remained unchanged. As the industry faced challenges in meeting requirements and limited Notified Body capacity, the availability of medical devices was at risk, impacting supply chains and healthcare.
Extended Transition Period
Regulation 2023/607 extends the MDD to MDR transition timeline based on the risk classification of medical devices:
- Class III and Class IIb Implantable Devices (with exceptions): Valid certificates issued by Notified Bodies from 25th May 2017 and not withdrawn since shall remain valid until 31st December 2027.
- Class IIb Devices (with exceptions), Class IIa, and Class I Sterile or Measuring Devices: Valid certificates issued by Notified Bodies from 25th May 2017 and not withdrawn since shall remain valid until 31st December 2028.
- Devices without Notified Body Involvement: Devices that did not require Notified Body involvement to obtain a CE certificate under the old regime, and for which the declaration of conformity was drawn up before 26th May 2021, will be valid until 31st December 2028, provided they meet specified conditions.
Abolishment of the ‘Sell-off’ Deadline
The Regulation removes the ‘sell-off’ deadline, set for 26th May 2025. This change allows devices already in the EU and EEA markets to remain in the supply chain and be made available to end-users indefinitely. This measure prevents unnecessary disposal of safe devices and ensures a steady supply during the transition.
Implications for Manufacturers
The extended EU MDR transition period and removal of the ‘sell-off’ deadline have several implications for medical device manufacturers:
- Additional Compliance Time: Manufacturers gain more time to adapt to the EU MDR regulation, conduct conformity assessments, and demonstrate compliance.
- Continuous Device Availability: A smooth supply chain ensures uninterrupted access to medical devices for healthcare providers and patients.
- Enhanced Planning and Quality Management: Manufacturers can strategize their transition, improve quality management systems, and enhance product offerings.
- Market Competitiveness: Companies can maintain their market presence and competitiveness while complying with regulations.
The finalized extension to the EU MDR transition period brings relief to medical device manufacturers, offering them essential breathing room during the transition. By strategically utilizing this additional time, manufacturers can meet compliance requirements, enhance product quality, and retain their competitiveness in the EU market.
Elexes medical consulting is one of the leading regulatory & compliance consultant for several industries: Medical device, Pharmaceuticals, Cosmetics, Food, and Biologics.