PRRC = Person Responsible for Regulatory Compliance
With the new EU MDR 2017/745 and IVDR 2017/746: By May 26th, 2020 you should have a new function on your organizational chart, the PRRC.
This acronym is for Person Responsible for Regulatory Compliance and you can find all the information about this function on article 15 of both regulations.
Mandatory position.
The new European Commission’s guidance on persons responsible for regulatory compliance (PRRC) explains that manufacturers, Authorized Representatives and micro and small manufacturers must designate at least one staff member responsible for ensuring compliance to the MDR and/or IVDR as appropriate according to Article 15 of the Regulation. PRRC qualifications are specific for each of these three operators.
A manufacturer’s PRRC must have either a formal qualification (university degree) in addition to a minimum of one year’s professional experience in medical device regulatory affairs or quality management; or four years of experience in regulatory affairs or quality management pertaining to medical devices.
European Authorized Representatives may also outsource their PRRC responsibilities to third parties, provided their subcontractors meet stated qualifications.
With the new EU MDR 2017/745 and IVDR 2017/746: By May 26th, 2020 you should have a new function on your organizational chart, the PRRC.
This acronym is for Person Responsible for Regulatory Compliance and you can find all the information about this function on article 15 of both regulations.
Mandatory position.
The new European Commission’s guidance on persons responsible for regulatory compliance (PRRC) explains that manufacturers, Authorized Representatives and micro and small manufacturers must designate at least one staff member responsible for ensuring compliance to the MDR and/or IVDR as appropriate according to Article 15 of the Regulation. PRRC qualifications are specific for each of these three operators.
A manufacturer’s PRRC must have either a formal qualification (university degree) in addition to a minimum of one year’s professional experience in medical device regulatory affairs or quality management; or four years of experience in regulatory affairs or quality management pertaining to medical devices.
- PRRC qualifications obtained outside the European Union should be recognized by an EU Member State as equivalent to an EU qualification;
- Organizations that have more than one legal manufacturer must designate a PRRC for each of its manufacturing entities;
- European regulators will generally assume that manufacturers based outside the EU will have PRRCs located outside the EU, as well.
European Authorized Representatives may also outsource their PRRC responsibilities to third parties, provided their subcontractors meet stated qualifications.
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