Manufacturers who sell devices intended for the European market
Great Britain-based device manufacturers who sell devices intended for the European market are also required to have available at least one person who possesses the requisite expertise as specified in the regulations.
Article 15 of the EU Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) describes the obligation for manufacturers (or their EU Authorised Representative) to have available a Person Responsible for Regulatory Compliance (PRRC). Meanwhile, MDCG 2019-7 ‘Guidance on Article 15’ provides clarification on how the Regulations should be interpreted.
“As to the location of the PRRC, it is important that a close linkage, of a permanent and continuous nature, is established between the PRRC and the manufacturing activities. For this reason, for manufacturers located outside the EU it must be assumed that the PRRC should also be located outside the EU.
To meet the intentions of the Regulations, GB Legal Manufacturers should have available within their organisation (an employee of that GB organisation) at least one person responsible for regulatory compliance (PRRC). Micro and small enterprises (SMEs) can outsource this requirement to an external GB-based PRRC such as IMed.
The requisite expertise of that GB-based PRRC shall be demonstrated by the following means,
(a) a diploma, certificate, or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognized as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices; or…
(b) four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
The five significant responsibilities of the PRRC are aligned in both the MDR and IVDR. They are:
- The PRRC will check the conformity of devices in accordance with the quality management system (QMS) the company uses before the device is released.
- PRRC will ensure that technical documentation and the EU documentation of conformity are available, accurate and up to date.
- The PRRC will make sure the company complies with post-market surveillance obligations specified in the Regulations
- The PRRC will be responsible for ensuring that the company fulfils its reporting obligations, which are also specified in the Regulations
- Finally, the PRRC will ensure that the specified requirements for investigational devices are met.
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