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REGULATION (EU) 2017/745 on medical devices

REGULATION (EU) 2017/746 on in vitro diagnostic medical devices

MDCG GUIDANCE 2019-07 Rev.1

FAQ

1. What qualifications do I need to fulfil the role of PRRC for a medical device manufacturer ?

• Article 15 of MDR and IVDR states that the necessary expertise can be met by either :

• A diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised 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

• Four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.

2. I have a degree (or diploma or other certificate) from a country outside of the EU.  Will this be acceptable for a PRRC ?

• Yes, if it has been recognised by an EU Member State as equivalent to the EU corresponding qualification.

3. I have a degree (or diploma or other certificate) from a country outside of the EU.  I have the required period of expertise in regulatory affairs for another world region (such as USA).  Will this be acceptable for a PRRC ?

• No, professional experience in regulatory affairs should be related to the EU requirements.

4. Does the PRRC have to be an employee of the medical device manufacturer ?

• Yes, if the manufacturer is larger than a micro or small enterprise (see question 5).
• No, if the manufacturer is a micro or small enterprise, in which case Article 15 states Micro and small enterprises within the meaning of Commission Recommendation 2003/361/EC shall not be required to have the person responsible for regulatory compliance within their organisation but shall have such person permanently and continuously at their disposal.

5. What is the definition of a “micro” or “small” enterprise ?

EC Recommendation 2003/361/EC states that:

• a small enterprise is defined as an enterprise which employs fewer than 50 persons and whose annual turnover and/or annual balance sheet total does not exceed EUR 10 million 

and

• a microenterprise is defined as an enterprise which employs fewer than 10 persons and whose annual turnover and/or annual balance sheet total does not exceed EUR 2 million