European Medical Device Regulation

With the start of application of the Medical Device Regulation (MDR) in 2021, the regulatory requirements for medical devices will increase. Among others, this applies also to manufacturers who want to bring substance-based medical devices to market. Notably, the necessary certification by Notified Bodies might emerge as a problem. Due to the Corona pandemic, the start of the validity of the European Medical Devices Regulation had been postponed for 12 months.

Examples for substance-based medical devices include drops for the treatment of dry eyes, nose sprays based on seawater, laxatives, products for bloating and gastrointestinal pain, various gels, creams and ointments. In contrast to medicinal products, substance-based medical devices do not achieve their intended purpose by a pharmacological, immunological or metabolic mode of action. The new Medical Device Regulation is the result of a long law-making process which was kicked-off in 2012. It will be immediately applicable in all EU Member States. Implementation into national law is not necessary. Consequently, the law will become far more extensive and more than before be dominated by European rules. Not only will regulatory density increase, but the character of rules will also change. Substance-based medical devices will have to face multiple tightenings of rules.

What does Pharma Deutschland offer medical device manufacturers?

In order to promote the exchange of expertise between its medical device manufacturers, Pharma Deutschland has set up its own "Material Medical Devices" committee. In this committee, members discuss current topics and develop solutions so that medical device manufacturers can implement the legal requirements in a practical and efficient manner.

Dental medical devices, such as dental filling materials or dental prostheses, are a special feature within the medical device sector. Pharma Deutschland supports manufacturers of these products with its own dental working group.

Pharma Deutschland also offers its members eleven other working groups and working groups in the field of medical devices.

How is the association involved in the medical device sector?

Many of these additional burdens represent enormous bureaucratic hurdles, especially for small and medium-sized companies, without bringing any decisive added value for patient safety. In fact, some of the requirements could lead to certain products no longer being available to patients in the future. Regulation (EU) 2023/607, published in the Official Journal of the European Union on March 20, 2023, was adopted to grant manufacturers longer transition periods for the implementation of the new MDR provisions, among other things. Unfortunately, this measure is not sufficient to solve the problem of the increasing shortage of medical devices. Pharma Deutschland is committed to ensuring that medical device manufacturers can continue to bring innovations to the market and make their products available to patients. The MDR must therefore be implemented pragmatically and with a sense of proportion. Pharma Deutschland represents the interests of its members at both German and European level and is in close contact with the Federal Ministry of Health and numerous stakeholders at European level in order to assist with the implementation of the new regulations and the adoption of non-legislative measures.

The European Commission has announced that it will carry out a comprehensive critical evaluation of the MDR by May 2027. If it turns out that the new regulations do not achieve the objectives or have a negative impact on patient safety, public health or medical innovation, the European Commission will propose changes if necessary. This could indicate further amendments to the MDR. These would be necessary to set binding deadlines for conformity assessment procedures and the issuing of certificates in accordance with Annex VII of the MDR, to predict and reduce costs, to abolish the maximum period of validity of certification attestations laid down in the law and to enable the application of the "equivalence principle" in practice within the framework of clinical evaluation. It is also essential to promote dialog between notified bodies and manufacturers. Pharma Deutschland is committed to a further amendment of the MDR.