New EU IVDR: Finalise your documentation and stay ahead of the game!

The goalposts keep moving…. On 16 February 2023, the European Parliament voted to amend the transitional provisions in Regulation (EU) 2017/745 on medical devices (“MDR”) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (“IVDR”).

The amendment, the result of pressure exerted by the medical device sector and the member states, will not introduce substantive revisions to the quality, safety, and performance requirements established in the MDR and the IVDR. It will, however, give manufacturers some additional time to comply with the Regulations and take the pressure off notified bodies, which are conducting the conformity assessments in accordance with the regulations.

According to the Commission, the measure is justified by the “imminent risk of shortages of medical devices and the associated risk of a public health crisis”. Nevertheless, we still advise everyone involved in the industry to start their processes and evaluations in order to avoid possible capacity issues for Notified Bodies.

The IVDR aim to improve product transparency and traceability and to create a less complex trading environment between EU member states by regulating the market with clearer rules. Depending the risk classification of the test involved, the new IVDR will take effect in May 2025, 2026, or 2027. Despite this breathing time, it is still important to start the transition as soon as possible.

In addition to the aforementioned changes, the European Commission has announced it will make a comprehensive assessment of the MDR by May 2027 to identify structural problems with the MDR and analyse potential solutions. The European Commission also intends to fund actions to support the implementation of the MDR, including notified body capacity and orphan medical devices. These actions will be funded under the EU4Health program starting in early 2023.

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