Medical Devices Regulation (MDR): A guide for importers

The introduction of the European Union's Medical Devices Regulation (MDR) in 2017, which came into full force in May 2021, has brought significant changes to the way medical devices are regulated in the EU. For importers of medical devices from Asia and other regions, this presents a series of new challenges and requirements. In this blog we explore what the MDR entails and what it means for importers.

What is the Medical Devices Regulation (MDR)?

The MDR (EU) 2017/745 is a regulatory framework designed to ensure the safety and quality of medical devices in the European Union. It replaces the previous Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD). The regulation sets stricter requirements for medical devices and their supervision in the EU market.

Key elements of the MDR

1. More stringent clinical requirements: The MDR requires more extensive clinical data to prove the safety and effectiveness of medical devices. This means that importers must ensure detailed clinical evaluations and, if necessary, clinical trials.
2. Improved traceability: Using a unique device identifier (UDI), all medical devices should be traceable throughout the supply chain, simplifying recalls and post-market surveillance.
3. Increased responsibility for importers: Importers must check whether the medical devices they import into the EU meet the MDR requirements. They are also required to register and report complaints and incidents.
4. Centralized database (EUDAMED): Information on medical devices should be entered into the European Medical Device Database (EUDAMED) to improve transparency and accessibility of data.
5. Risk classification: The MDR introduces new rules for the classification of medical devices, which may lead to a higher risk category for some products.

Authorised representative in the EU

Within the regulations of the Medical Devices Regulation (MDR), there is an important requirement regarding the representation in the European Union (EU) of manufacturers located outside the EU. These regulations state that manufacturers of medical devices that are not established in the European Union must appoint a European Authorised Representative (EU Authorised Representative or EU AR). Here's what you need to know:

As an importer, it is crucial to work with manufacturers who have appointed a reliable and competent EU Authorized Representative. This is essential for:

• Ensuring compliance with EU regulations.
• Minimizing risks of non-conformity and possible legal implications.
• Maintaining the integrity of the supply chain.

An example of product information for wound plasters.

What does this mean for importers?

For importers, the MDR means a significant increase in responsibilities and obligations. Here are some crucial steps:

1. Collaboration with certified suppliers: Importers must ensure that their suppliers in Asia or other regions meet MDR requirements. This may mean finding new suppliers or helping existing suppliers comply with regulations.
2. Thorough documentation: The obligation to maintain extensive documentation, such as declarations of conformity and technical files, is essential.
3. Post-market surveillance: Importers must establish systems for monitoring the safety and performance of medical devices after they have been placed on the market.
4. Registration requirements: Importers must register themselves and their products in EUDAMED.
5. Preparedness for inspections and audits: Importers should be prepared for possible inspections and audits to ensure compliance with the MDR.

Conclusion

The implementation of the MDR is a challenge, but also an opportunity for importers. By complying with the new regulations, importers can not only meet regulatory requirements, but also increase consumer and stakeholder confidence in the quality and safety of their products. It is essential to take the necessary steps to fully comply with the MDR and thus maintain and strengthen access to the lucrative European medical device market.