On 5th April 2017 the European Parliament published an official press release announcing that New Medical Devices and In-Vitro Diagnostics Devices Regulations have been finally adopted. The final texts of the new Regulations were published in the Official Journal on 5th May 2017. With the adoption of the Medical Devices Regulation the obligations of the EU distributors will significantly change in comparison with the current legislative regime.
Some of the most important changes concerning distributors under the new Medical Devices Regulation include:
- Ensuring devices have been CE marked and the EU Declaration of Conformity has been drawn up
- Ensuring the Unique Device Identification (UDI) has been assigned
- Not distributing non-conforming devices
- In case of non-conformity, informing the Manufacturer, the European Authorized Representative (EAR) and the relevant Competent Authorities
- Forwarding any complaint or incident to the manufacturer, the EAR and the Importer
- Keeping a register of complaints, of non-conforming devices and of recalls and withdrawals
Distributors acting as European Authorized Representatives
The new Medical Devices Regulation requires from manufacturers and Authorized Representatives to have available a person responsible for regulatory compliance. This person should possess expertise in the field of medical devices, demonstrated by certain qualifications. Distributors, who are usually commercial entities and do not have available such a person, would therefore not be allowed to act as Authorized Representatives. This is why it is highly recommendable for manufacturers to work with a professional, regulatory company, such as Obelis, which possesses necessary experience and expertise to meet all the legal requirements of the new Medical Devices Regulation.
If you wish to know more about the new requirements on distributors brought about by New MDR & IVDR, 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 products’ compliance.