EU MDR/IVDR: New Transitional Provisions Enter into Force
The 6-page amending Regulations (EU) 2023/607 with new transitional provisions for certain medical devices and in vitro diagnostic medical devices was published in the Official Journal of the European Union on 20 March 2023. It entered into force upon publication. This is intended to alleviate supply shortages of important medical devices (we reported). The regulation is binding in its entirety and directly applicable in all member states.
Articles 120, 122, and 123 of the MDR have been amended. Legacy products with a valid certificate may be placed on the market up to these deadlines, depending on the risk class:
- For custom-made implantable devices in class III: until 26 May 2026.
- For higher-risk devices: until 31 December 2027. This includes Class III devices and Class IIb implantable devices, excluding sutures, braces, dental fillings, dental braces, dental crowns, screws, wedges, plates, wires, pins, clips, and connectors.
- For medium and lower risk products: until 31 December 2028. This includes other class IIb products, class IIa products, and products of classes ls, lm, lr.
What conditions must be fulfilled?
- The products comply with Directive 90/385/EEC or Directive 93/42/EEC.
- There are no significant changes in the design and intended purpose.
- The devices do not present an unacceptable risk to the health or safety of patients, users, or other persons or to other aspects of public health protection.
- The manufacturer has a quality management system in place in accordance with Article 10(9) by 26 May 2024 at the latest.
- The manufacturer or authorised representative has submitted a formal application for conformity assessment to a notified body no later than 26 May 2024. The notified body and the manufacturer have signed a written agreement for MDR certification no later than 26 September 2024. This regulation also applies to custom-made implantable devices of class III.
- The notified body must be designated under the MDR in September 2024 to perform its monitoring responsibilities.
According to the new version of Art. 120 (4) MDR, the sell-off period, which was originally scheduled until 27 May 2025, has been deleted without replacement. For in vitro diagnostic medical devices, Art. 110 (4) also provides for the deletion of the sell-off period. This prevents products that have already been placed on the market and are still available from having to be withdrawn from the market.
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