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Anne JURY
June 17, 2020
Medtech Insight article from Amanda Maxwell

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?

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Medtech Insight article from Amanda Maxwell

Medtech Insight article from Amanda Maxwell

New EU Association Supports EU Regulatory Compliance Role As Responsibilities Take ShapeHow will...

Anne JURY
June 17, 2020
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