EC Rep and MDR Compliance
Role of an EU Authorized Representative in Medical Device Compliance (MDR)
The role of an Authorized Representative (AR) is indeed an important aspect of compliance with European Union (EU) regulations, including the Medical Device Regulation (MDR). The MDR requires medical device manufacturers based outside the EU to appoint an Authorized Representative if they wish to place their products on the EU market.
The Authorized Representative acts on behalf of the manufacturer and assumes certain responsibilities to ensure compliance with the applicable regulations. Their primary role is to serve as a point of contact between the manufacturer and the EU regulatory authorities.
Here are some key functions of an Authorized Representative:
Representation: The AR represents the manufacturer within the EU and communicates with the relevant authorities on their behalf. They must have a written mandate from the manufacturer to act in this capacity.
Regulatory Compliance: The AR assists the manufacturer in meeting their regulatory obligations under the MDR. They review the technical documentation, verify conformity assessments, and ensure compliance with EU standards and requirements.
Device Registration: The AR may be responsible for registering the manufacturer and their devices with the relevant regulatory authorities in the EU member states where the products will be marketed.
Post-Market Surveillance: The AR collaborates with the manufacturer to monitor the safety and performance of the devices placed on the market. They may assist with reporting adverse events, field safety corrective actions, and other post-market surveillance activities.
Coordinating with Competent Authorities: The AR acts as a liaison between the manufacturer and the competent authorities of the EU member states. They handle communication regarding product inquiries, inspections, and any regulatory actions that may arise.
It's important to note that the role of an Authorized Representative is distinct from that of a Notified Body. Notified Bodies are independent organizations designated by EU member states to assess the conformity of certain medical devices. While the AR assists with regulatory compliance, Notified Bodies perform conformity assessments and issue certifications.
The requirements for appointing an Authorized Representative are outlined in Article 11 of the MDR. Manufacturers must carefully select a qualified and experienced AR to ensure proper compliance with EU regulations and to navigate the complexities of placing medical devices on the EU market.