Article 15 of Regulation (EU) 2017/745 on medical devices and Article 15 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices formally introduce the requirement for each manufacturer (and each authorised representative) to designate a Person Responsible for Regulatory Compliance (PRRC). This requirement aims to ensure the continuous compliance of devices placed on the market, regardless of their class or medical purpose.
This obligation applies to all types of devices:
- Implantable or non-implantable
- Active or non-active
- Standard or custom-made
- With or without a medical purpose
Who Needs a PRRC?
- Manufacturers
All manufacturers placing CE-marked medical devices on the EU market are required to appoint a PRRC.
- Authorised Representatives (ARs)
EU-based authorised representatives acting on behalf of non-EU manufacturers are also required to designate a PRRC.
Other economic operators such as distributors, importers, and assemblers are not required to have a PRRC.
Roles and Responsibilities of the PRRC
The PRRC plays a critical role throughout the regulatory lifecycle of a medical device. The main responsibilities include :
- Verifying the conformity of devices prior to their release, relying on the manufacturer’s quality management system.
- Preparing and updating technical documentation, including the EU declaration of conformity.
- Post-market surveillance obligations: monitoring device performance and safety after it has been placed on the market.
- Reporting obligations to competent authorities in the event of incidents or significant changes.
- Submitting declarations in case of clinical investigations and performance studies, as required by the regulation.
🔒 Independence Guarantee : The regulation ensures that the PRRC cannot be disadvantaged in carrying out their duties, whether they are an employee of the company or an external party.
Required Qualifications to Act as a PRRC
There are two possible routes to qualify as a PRRC, as set out in the regulation:
1. Academic Path + Experience
- A diploma (or certificate) in law, medicine, pharmacy, or another relevant scientific discipline.
- ≥ 1 year of professional experience in regulatory affairs or quality management systems related to medical devices/or in vitro diagnostic medical devices.
- For custom-made devices: ≥ 2 years of experience in a relevant manufacturing field.
2. Professional Experience Path
- ≥ 4 years of professional experience in regulatory affairs or quality systems applicable to medical devices /or in vitro diagnostic medical devices.
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PRRC Role Based on Company Size
The regulation acknowledges structural differences between large companies and SMEs:
- Large enterprises: The PRRC must be a permanent part of the organization.
- Micro and small enterprises*: The PRRC role can be outsourced, provided the person is permanently and continuously available.
Multiple PRRCs: If more than one person is appointed, they share joint responsibility for regulatory compliance. Their respective responsibilities must be clearly defined in writing, and each individual must meet the qualification requirements.
Registration and Compliance
Since the Regulation came into effect on 26 May 2021, the contact details of the PRRC must be registered in EUDAMED, the European database for medical devices.
(See our blog post on EUDAMED for more details.)
Useful References
- Article 15 of Regulation (EU) 2017/745 on medical devices
- Article 15 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices
- SNITEM Guide – The Person Responsible for Regulatory Compliance
*Commission Recommendation 2003/361/ΕC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises:
-Within the SME category, 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.
-Within the SME category, 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.
Article written by Camille NEERMUL, Senior Consultant in Quality and Regulatory Affairs for medical devices