The New EU Medical Devices Regulation 2017/745 has entered into force on May 25th with a transition period of 3 years, setting the date of application on May 26th 2020. While manufacturers shall use the transition period to update their technical documentation and processes in order to meet the new requirements, European Authorized Representatives (E.A.R.) have to be also ready to meet their new obligations.
- The EAR must have a written mandate signed by the manufacturer and the A.R.
- The manufacturer shall enable the A.R. to perform at least the following tasks:
- verify that the EU declaration of conformity and technical documentation are available and up-to-date; verify that an appropriate conformity assessment procedure has been carried out;
- ensure that the technical documentation, DoC & relevant certificates are available for 10 years (medical devices) and 15 years (implantable devices) after the last device placed on market;
- register on EUDAMED to obtain a single registration number (SRN);
- pass on requests for information to the manufacturer; pass information to the Competent Authorities (CA) when requested;
- verify that the manufacturer has complied with the Unique Device Identification (UDI) requirements;
- cooperate with the CA on any preventive or corrective action taken to eliminate or mitigate the risks posed by devices;
- immediately inform the manufacturer of complaints or reports on devices;
- terminate the mandate if the manufacturer acts contrary to its obligations under the Regulation, and immediately inform the CA and notified body.
- The manufacturer cannot delegate some obligations, such as: design and manufacture, risk analysis, clinical evaluation, technical documentation, declaration of conformity, or UDI compliance.
- Where the manufacturer is not established in a Member State and has not complied with General Obligations of the Manufacturer (article 10), the A.R. shall be legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer.
Furthermore, the Article 15 of MDR 2017/745 lists obligations of EAR regarding the person responsible for regulatory compliance. Each EAR shall have permanently and continuously at their disposal at least one person responsible for regulatory compliance, who possesses the requisite expertise regarding the regulatory requirements for medical devices in the Union.
Perspectives and Potential Impact
E.A.R.s will continue to deal with both pre-market and post-market compliance and regulatory issues on behalf of manufacturers, and their current role as liaison officer between non-EU manufacturer and national Competent Authority will remain unchanged. However, Authorized Representatives will take on more risk and liability under the new Regulation – the E.A.R. will be held jointly and severally liable for defective medical devices. This change could have impact on foreign manufacturers, as they could expect more thorough due diligence and scrutiny from potential Authorized Representative partners.
Should you have any questions or wish to know more about European Authorized Representative role under the new Regulation, please do not hesitate to contact us. Obelis Expert Consultants, having nearly 30 years of experience with EU Regulations, will gladly answer any question you may have and will gladly assist you in safeguarding your devices’ compliance.