In May 2017, the Medical Device Regulation (EU) 2017/745 (MDR) entered into force, replacing the old Medical Device Directive (MDD; 93/42/EEC medical devices). For a time period of 3 years following the entry into force of the MDR, manufacturers could choose to certify their products either under the new MDR or under the old MDD.

However, as of May 26, 2020, this is no longer possible. Existing products (certified under MDD) may stay on the market until their certification expires, or until May 2024 at the latest. Substance-based medical devices class I that are not reclassified and were produced until May 25, 2020 can stay on the market until already distributed stock runs out.

What’s Different?
What are the main differences between MDD and MDR? One thing is complexity. While the MDD consisted of 23 articles, the MDR comprises 10 chapters with a total of 123 articles and 22 annexes. The new regulation introduces more specific requirements for the technical documentation.

Here are some other key highlights. All substance-based medical devices now require certification by a Notified Body (NB). There are stricter and more specific requirements with respect to Clinical Evaluation, Post-Market Clinical Follow-up (PMCF), and Post-Market Surveillance (PMS). It is prohibited to use misleading texts, names, trademarks, pictures, and figurative signs.

Except for small companies, manufacturers now need to name a responsible person for regulatory compliance. Both the unique device identification (UDI) data and post-marketing data (e.g., periodic safety update report (PSUR)) must now be submitted to the publicly accessible EUDAMED, the European Database on Medical Devices.

What are the main implications for substance-based MD under the MDR? Most significantly, substance-based medical devices class I are no longer marketable without re-classification followed by re-certification, as these products need to be upgraded to at least class IIa. All products need to comply with MDR by May 2020 unless they have received a renewed certification under MDD. In this case, the technical documentation for these medical devices must be updated according to the new regulation. Also, all medical devices need to comply with the new requirements of the Clinical Evaluation Report (CER) according to MEDDEV 2.7/1/Rev 4.

In order to keep their products on the market, manufacturers of substance-based medical devices need to upgrade their product technical documentation according to MDR and, when necessary, invest in clinical data.

Of course, there are other challenges, such as how to assess and mitigate the risks of difficulties in the re-certification process, or how to set up a feasible and robust MDR compliant strategy for PMS and PMCF. Manufacturers must also demonstrate clinical efficacy of their product under MEDDEV 2.7/1/Rev 4 (Clinical Evaluation Report – CER) and demonstrate clinical and safety requirements for their product.

It does not end there. Some other new tasks are performing Biological Evaluation for substance-based medical devices, providing the necessary “substance-based information” according to Annex II, point 6.2 (c) of MDR; conducting substantiation of equivalence for the product; and building data for the Periodic Safety Update Report (PSUR).

If the product in question is already on the market, FBOs should identify and close gaps in the product’s technical dossier. Also, a key requirement under MDR is the CER; compiling this report may require additional clinical data or even a new clinical trial to be conducted.

All these issues and tasks may seem a little daunting, and some, such as conducting a clinical trial, may even be outside of the capabilities of smaller companies. Therefore, it makes sense to approach experts in this area. Some consultancies, like analyze & realize GmbH, offer advice on all aspects of medical device certification, both under MDD and under MDR, including the conduct of clinical trials and support with the various evaluation reports, the PSUR, and post-market follow-ups.

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Joerg Gruenwald
analyze & realize ag

Dr. Joerg Gruenwald is co-founder of analyze & realize GmbH, a specialized business consulting company and CRO in the fields of nutraceuticals, dietary supplements, herbals and functional food, and author of the PDR for Herbal Medicines. He can be reached at analyze & realize GmbH, Waldseeweg 6, 13467 Berlin, Germany; +49-30-40008100; E-mail: [email protected]; Website: www.analyze-realize.com.