As a result of the new European Union Medical Device Regulations (MDR), existing products (most legacy devices) that already had received CE Mark under the previous Medical Devices Directive (MDD), will need to be re-certified. In April 2020, the Medical Device Coordination Group (MDCG) issued clinical evidence recommendations for those devices.
The MDCG suggests to adopt a hierarchical ranking of clinical evidence, which ranges from high-quality clinical investigations covering all device variants and indications (Rank 1) to preclinical and bench testing (Rank 12). Ranks 1 to 4 imply outcomes from high-quality clinical studies or registries are needed. Equivalence data (Rank 5) and evaluation of clinical data from similar devices (Rank 6) could be considered only as supportive. All other lower-ranked data sources (e.g. complaints and vigilance data, individual case reports, non-clinical safety data) are not generally regarded as high-quality data due to limitations in reporting. Class III legacy devices and implantable legacy devices that are not well-established technologies should have sufficient clinical data as a minimum Rank 4.
The proposal is not legally binding, but should nevertheless play an essential role in the regulatory decision making in practice.
Implications for Innovators
Due to the COVID-19 crisis, implementation of the EU’s MDR is postponed for one year and now will take effect on 26 May 2021. New deadlines are:
- May 2022 – Expiration of EC certificates of conformity issued before May 27, 2017
- May 2024 – Expiration of all EC certificates issued 5 years from the issue/renewal date or 4 years from the MDR date of application
- May 2025 – End of marketability of devices certified under the MDD
The recently issued guideline of the MDCG provides the benchmarks for the expectations in clinical evidence to be met for re-certification. It is recommended that companies which have not yet started to begin the preparation of GSPR clinical evidence strategy for their Class II and III legacy medical devices, or refine their process accordingly.
Veranex’s (formerly Boston Healthcare Associates) European office in Berlin, Germany, can support manufacturers and developers in the identification of evidence gaps and strategies for evidence development to meet the conformity assessment. Please contact us to learn more.