New EU Medical Device Regulation requires stakeholders to have access to qualified regulatory expertise

A new requirement of the European Medical Device Regulation (EU 2017/745 [MDR]) and In-Vitro Diagnostic Regulation (EU 2017/746) means that manufacturers and Authorized Representatives for medical devices and in-vitro diagnostics must have a person who will be responsible for regulatory compliance (PRRC) to ensure that a device is compliant.

All device manufacturers who have more than 50 employees or have a turnover of €10million must have a full time PRRC within the organization. Smaller companies who do not meet these criteria are able to outsource the responsibilities to a third party. In addition, for manufacturers outside of the EU, Authorized Representatives within the EU must confirm that they have a PRRC in place, either in-house or subcontracted.

Expertise needed by a PRRC:

To be eligible to perform the role of a PRRC, an individual’s expertise must be demonstrated in one of two ways. Either an individual must have

1. a) at least four years of professional experience in regulatory affairs or in the quality management systems related to medical devices; or
2. b) a diploma, certificate or any other recognized evidence of a formal qualification awarded following completion of a university degree or equivalent course in medicine, law, pharmacy, engineering, or other recognized scientific discipline. As well as one of the above qualifications, individuals must have completed at least one year of professional experience in regulatory affairs related to medical devices.

Any qualification acquired outside of the European Union (such as certificates or diplomas) must be deemed by the EU member state to be equivalent to the corresponding EU qualification. In addition, professional expertise should also be coherent with EU requirements.

What are the roles of a PRRC?

Regulatory responsibilities of the PRRC include ensuring alignment with the quality management system, making sure that technical documentation for CE marking and EU declaration of conformity are up to date, while also fulfilling post-marketing surveillance and reporting obligations. Often the role also includes confirming that EU-specific requirements are being followed, such as ensuring that packaging and instructions are in the correct language for each country The role of PRRC can be divided between multiple individuals if all responsibilities are completed and the division of tasks is well documented.

How PLG supports manufacturers

ProductLife Group can fulfil all aspects of the Authorized Representative role, which also involves ensuring that a PRRC is in place. For smaller companies, PLG offer tailored support by being an Authorized Representative and outsourced PRRC. For companies who have people in role, PLG can provide support to the PRRC at times of increased workload. ProductLife Group ensure that you have the best regulatory support for your organization.