As of Monday, 20 March 2023, the much-awaited EU Regulation 2023/607 became part of EU legislation, meaning it is now vital that medical device companies comply with this regulation.
This change is an important one, as it allows medical device manufacturers more time to certify their medical devices, with the hope of preventing patients from being unable to access the medical devices they need.
Overview of EU Regulation 2023/607
EU Regulation 204/607 is an amendment of Regulations (EU) 2017/745 MDR and (EU) 2017/746 IVDR and covers:
- The extended transitional provisions for certain medical devices and in vitro diagnostic medical devices – dependent on their risk class. Higher-risk devices, such as hip implants and pacemakers, have a shorter transition period (December 2027), while medium and lower-risk devices, such as reusable surgical instruments and syringes, have until December 2028.
- A transition period for class III implantable devices until 26 May 2026
- The removal of the “sell-off” period covered in the MDR and IVDR. This period was designed to limit the time in which compliant medical devices already placed on the market before the Date of Application (DoA) of the new MDR and IVDR may be sold. This new regulation means manufacturers can still place MDR and IVDR legacy devices onto the market within the new deadlines set by the extended transition period.
It is important to note that these extensions are subject to several conditions to ensure that only safe devices are placed on the market, for which MDR conformity assessment has been applied for before 26 May 2024.
Navigating EU Regulation 2023/607 for Medical Device Compliance
What does the extended transition period mean for the medical device industry?
Firstly, Regulation (EU) 2023/607 does not apply to all manufacturers and MDR legacy devices. To benefit from the extended transition period, medical device manufacturers must:
- Establish a quality management system (QMS) compliant with the MDR by 26 May 2024
- Submit a formal application to a Notified Body for the conformity assessment by 26 May 2024
- Enter into an agreement with the Notified Body for the conformity assessment by 26 September 2024
The transition period will also only apply to MDR legacy devices if:
- They continue to comply with the relevant directive
- Significant changes to the design or intended use are not presented
- Unacceptable risks to the health and safety of patients and users are not shown
Regulation (2023/607) also contains additional requirements for manufacturers wanting to benefit from the extended transition period for legacy devices that have an expired certificate, and these are:
- The medical device manufacturer has concluded a contract with a Notified Body for conformity assessment under the MDR before the expiration of the certificate
- The medical device manufacturer benefits from an exemption under Article 59 or 97 of the MDR
The extension of the transition period is good news for medical device manufacturers, no doubt about it. However, actions still need to be taken to ensure your device complies with the new rules, and Shiro can help you with those. We work in partnership with MedEnvoy as your EU Authorized Representative (EAR) and Swiss Authorized Representative (CH-REP) to not only help you assess if Article 97 (1) Application applies to your CE Certificate but also help you apply for it if it does.
If you have any questions about the process or how we can help to guide you through it, please do not hesitate to get in touch with us at 0333 224 0945 or email us at firstname.lastname@example.org