EU-MDR: European Parliament Votes in Favour of New Transition Periods
On 16 February 2023, the European Parliament voted positively to extend the deadline for the certification of medical devices under the EU Medical Devices Regulation (MDR). In January, the deadline extension was proposed by the European Commission to prevent massive supply shortages. Not enough Notified Bodies are available for the recertification of many medical devices, as a requirement of the MDR.
What will be amended?
These certification deadlines for manufacturers are staggered according to a risk-based approach:
- 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.
The recent decision has dropped the sell-off deadline for all medical devices specified in the MDR/IVDR. This prevents products that have already been placed on the market and are still available in the trade from having to be withdrawn from the market.
The next official step for the amendment of the MDR/IVDR is the signing and subsequent publication in the Official Journal. On that day, the draft regulation will then enter into force.
Meet the GMP Compliance Adviser
The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business.
The demo access is non-binding and ends automatically.
You may also be interested in the following articles:
