As part of the Corrigendum No. 2 of the new (EU) Medical Devices Regulation No. 2017/745 (MDR), the Parliament of the European Union has finally decided on the eagerly awaited, additional four year transitional period for medical devices which are currently classified as class I devices. Under the new MDR, these will be moved to a higher risk class and therefore require the involvement of a notified body for the first time.
Prior to this Corrigendum, a four year transitional period was only applicable to medical devices which were already on the market and required the involvement of notified bodies under the current legal framework, i.e. medical devices qualified as class Is, Im, IIa, IIb and III products. Accordingly, all class I medical devices which will be subject to a higher risk class under the MDR would not have benefited from this transitional period. In practical terms, this would have meant that these medical devices had to comply with the new regulations by 26 May 2020, including the completion of the requested involvement of a notified body – a barely manageable task given that, until today, far too few notified bodies have been designated in accordance with the new law. In numbers, 8 notified bodies are currently designated under the MDR regime, compared to 58 notified bodies qualified to assess and evaluate medical devices under the current regime of the Medical Device Directive (MDD).
In the light of this, the additional four year transitional period provides much-needed relief for medtech companies. However, the current bottleneck of notified bodies, and the corresponding lead times for conformity assessments and certification procedures for new products, do not relieve manufacturers of medical devices from needing to take the necessary steps now to ensure MDR compliance of their medical devices after the end of the transitional period. In order to enjoy the benefits of the transitional period, manufacturers must ensure compliance of their medical devices with the current requirements of the MDD during the transitional period, starting on 26 May 2020.