Article 59 (EU MDR) and CE Marking FAQ

Q: What is EU MDR Article 59?

A: Article 59 of EU MDR pertains to the authorization of CE Marking requirements derogation for medical devices (excluding IVDs). It allows non-CE-marked compliant products to be sold in Europe if they are urgently needed and if certain criteria are met.

Q: What is Article 59’s purpose?

A: Article 59 is designed to handle situations where medical devices are of vital importance, there are no sufficient substitutes available, and CE Marking is not achievable within a reasonable timeframe. It offers a mechanism to ensure the availability of critical devices while maintaining public health and safety standards.

Q: How does the derogation authorisation process work?

A: The derogation authorization process involves consultation with Member States through the Medical Device Coordination Group (MDCG) to determine if a derogation is relevant to the Union. If relevant, the Commission assesses procedural requirements and decides on Union-wide derogation based on specific criteria.

Q: What criteria is considered for derogation authorisation?

A: Derogation authorization is contingent upon factors such as efforts to achieve CE Marking, vital importance of the device, absence of sufficient substitutes, no indication of risks to public health, and temporary nature of the derogation.

Q: How long can derogation last?

A: Union-wide derogations can last up to six months. Member States can apply stricter criteria than the implementing act. The derogation duration is expected to match the timeline for achieving CE Marking.

Q: What responsibilities do manufacturers have when invoking Article 59?

A: Manufacturers should initiate the Article 59 process once their conformity assessment is ready for Notified Body review. They need to prove that the device is irreplaceable without unacceptable risks and explore alternatives. A working quality management system and a Notified Body certificate are beneficial during this process.

Q: How do Competent Authorities handle the derogation process?

A: Competent Authorities review technical documentation and assess the urgency of derogation. The manufacturer must demonstrate the device’s irreplaceability and insufficient alternatives. Devices sold in multiple Member States involve multiple Competent Authorities, each with unique procedures and duration for authorization.

Q: When it is appropriate to use Article 59?

A: Article 59 should be considered when a non-CE-marked compliant product is urgently needed in the EU market. However, it’s important to note that leveraging this derogation process is complex and should align with ongoing CE mark certification at a Notified Body.

Q: How can manufacturers navigate the derogation process effectively?

A: Clin-r+ recommends manufacturers to approach the Member State where the notified body is based with an Article 59 derogation request, leveraging their influence to ensure smoother administrative processes. Avoiding legal actions against a notified body and maintaining friendly relations is also advised.