The Medical Device Regulation (MDR) in General

The Medical Device Regulation (MDR) defines the rules for the certification of medical devices in Europe. It came into force on May 26, 2017, and will repeal Directive 93/42/EEC starting from May 26, 2021. Medical device manufacturers, depending on the case, will have to comply by May 26, 2025 at the latest.

The objective of the MDR is to create a new regulatory framework recognized internationally and increase the clinical safety of products. Moreover, a regulation, unlike directives, does not need to be transposed into national law, limiting divergent interpretations among different European Union states.

Among the subjects affected by the Medical Device Regulation (MDR) are not only manufacturers and authorized representatives. Unlike the current directive, the regulation contains obligations also applicable to importers and distributors.

The Main Reason for the Change

The presence of serious incidents and significant differences in interpretation of the directive have brought to light serious shortcomings in the current regulatory framework. As indicated by the European Commission, it was necessary to revise the legislation to increase the high standards of quality and safety of products and consolidate the EU’s role as a world leader in the medical device sector.

However, the resulting Medical Device Regulation (MDR) is very complicated.
The stringent – and sometimes unclear – requirements and implementation timelines move at a different speed compared to the capabilities of organizations, notified bodies, and competent authorities themselves.

For this reason, the organizations involved (manufacturers, importers, distributors, and authorized representatives) must make timely strategic decisions, focus on training, and adapt to the MDR, even with the support of external consulting firms.

Transitional Provisions

The transitional provisions in Article 120 of the Medical Device Regulation define the timelines for implementing the new requirements.

Below are the most important ones:

• The requirements for surveillance, vigilance, registration of economic operators and devices apply to all organizations from May 26, 2021.
• Certificates issued by notified bodies according to 93/42/EEC remain valid until the end of the period indicated on the certificate. However, they lose validity at the latest on May 27, 2024.
• A Class I device under Directive 93/42/EEC that changes class or requires the involvement of a notified body can be placed on the market until May 26, 2024.
• Devices placed on the market according to 93/42/EEC before May 26, 2021, can continue to be made available on the market until May 26, 2025.