On 26 May 2021, the new Regulation (EU) 2017/745 on medical devices came into force. It is also commonly referred to as the MDR (Medical Devices Regulation).

This brings about a great many changes for manufacturers, distributors and operators (physiotherapists, alternative practitioners and doctors) of medical devices

– And yes! This includes microcurrent devices too –

On 25 May 2017, the MDR was published in the Official Journal of the European Union, and was due to become binding for all Member States on 26 May 2020. Due to the coronavirus pandemic, the date for the MDR to come into force has been postponed to 26 May 2021.

Now it’s time to act!

The MDR is intended to provide a robust, transparent, predictable and sustainable legal framework for medical devices. This is how it is described in the first recital. The MDR’s overriding principle is the level of protection for patients and users. At the same time, however, the aim is also to boost the level of innovation in medical devices. It remains to be seen whether the drafters of the MDR have truly taken the issue of innovation to heart.

Many believe that the so-called PIP scandal in France, involving substandard materials in breast implants, was the catalyst for the MDR; however, plans and ideas for a new regulation on medical devices were already in place before the PIP scandal. Nevertheless, the PIP scandal can certainly be described as a driving force behind the MDR. The then EU Commissioner for Health and Consumers – John Dalli – presented a PIP Action Plan. According to this, the following areas were to be strengthened: the functioning of notified bodies, market surveillance, coordination of surveillance, as well as communication and transparency.

Manufacturers of medical devices must now comply with entirely new standards (this does not refer to technical standards, as these have changed little or not at all during the transition from Directive 93/42/EEC to the MDR) and thus establish new or revised processes within their organisations.

The topic of quality management is described and required ‘in detail’ in a regulation for the first time. In addition, there are significantly higher requirements for market surveillance and the clinical evaluation of medical devices. [um nur einige wenige Änderungen zu nennen]

But how do the key players – namely the manufacturers, the notified bodies and the authorities themselves – actually view this? Do they see the MDR as a risk or as an opportunity?

What do distributors and practitioners – such as physiotherapists, alternative practitioners and doctors – need to bear in mind?

Here are the links for this episode:

The book:
https://www.bod.de/buchshop/die-neue-verordnung-eu-fuer-medizinprodukte-2017745-patrick-walitschek-9783748149064

The legislation:
MPBetreibV: https://www.gesetze-im-internet.de/mpbetreibv/
MPDG: https://www.gesetze-im-internet.de/mpdg/
MDR: https://eur-lex.europa.eu/legal-content/DE/TXT/?uri=CELEX%3A32017R0745