Medtech Insight article from Amanda Maxwell

New EU Association Supports EU Regulatory Compliance Role As Responsibilities Take Shape

How will the new, not-for-profit European association, TEAM-PRRC, support the many regulatory experts – perhaps more than 50,000 individuals - who take on the new weighty responsibilities that come with the role of Person Responsible For Regulatory Compliance (PRRC) under the EU MDR?

Elem Ayne, president of TEAM-PRRC and Anne Jury, vice-president, talked to Medtech Insight about the uncertainty that remains around this role and how TEAM-PRCC hopes to influence EU guidance that is being developed for the PRRC role in an interview with Medtech Insight.

Issues covered include: the biggest challenges ahead for the PRRC; where the PRRC should be located; liability; the overlap with the authorized representative role; recruitment challenges; and the UK position.

The full interview with Medtech Insight’s Amanda Maxwell is available to MI subscribers here: https://medtech.pharmaintelligence.informa.com/MT142261/New-EU-Association-Supports-EU-Regulatory-Compliance-Role-As-Responsibilities-Take-Shape?