The PRRC (Person Responsible for Regulatory Compliance) is one of the new requirement of the EU MDR European Medical Device Regulation and In-Vitro Diagnostic Regulation 2017/745 and 2017/746.
The requirements for the appointment of a PRRC is described in the article 15 of the EU MDR and it requires manufacturers are required to confirm that their EU authorised representative has appointed a person meeting the PRRC qualifications. Moreover, there is a specific MDCG guideline that further clarifies the role of the Person Responsible for Regulatory Compliance.
What are the minimum qualification to ba appointed as PRRC?
The PRRC shall demonstrate specific expertise in the field of medical devices, in one of the following qualifications:
- Four years of professional experience in regulatory affairs or in quality management systems relating to medical devices;
- Diploma, certificate (or other formal qualification) from a university degree in law, medicine, pharmacy, engineering or other relevant scientific discipline (recognized as equivalent by the Member State concerned) and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices.
What are the responsibilities of the Person Responsible for Regulatory Compliance?
The responsibilities of the PRRC are described in the Article 15 of EU MDR 2017/745 and EU IVDR 2017/746 and they can be summarised below
- The conformity of the devices is properly checked, in accordance with the quality management system under which the devices are manufactured, before a device is released.
- The technical documentation and the EU declaration of conformity are drawn up and kept up to date
- The post-market surveillance obligations are complied with in accordance with the requirement of the MDR
- Reporting obligations are fulfilled.
Does every medical device company needs to have a Person responsible for Regulatory Compliance?
In general, every medical device manufacturer shall appoint a PPRC. However, medical device manufacturers with less than 50 employees and under 10 million Europes in global sales revenue, are not required to have a person responsible for regulatory compliance within the organisation.
In larger organizations the regulations allow for more than one person to be designated for this role. This enables larger companies to have an entire team functioning as their PRRC.
Drafting a robust contract agreement becomes imperative, especially when delegating regulatory compliance obligations to an external professional, such as a freelance consultant serving as the Person Responsible for Regulatory Compliance (PRRC). This agreement is not only essential for delineating roles, responsibilities, and confidentiality requirements but also aligns with the stipulations of Article 15 of EU MDR 2017/745. By incorporating the mandates outlined in this regulation into the contract, organizations ensure adherence to regulatory standards, mitigate risks of non-compliance, and uphold the integrity of their products and processes. Such contractual clarity not only fosters a collaborative environment but also establishes a solid foundation for navigating the intricacies of regulatory compliance effectively.
Responsibilities of the PRRC for investigational devices
According to Section 4.1 of Chapter II of Annex XV , organisations shall ensure that a specific statement is signed by the natural or legal person responsible for the manufacture of the investigational device that the device in question conforms to the general safety and performance requirements.
The PRRC versus the EU Authorised Representative
The role of the PRRC is different from the role of European Authorized Representative. An authorised representative means any natural or legal person established within the European Union who has received and accepted a written mandate from a manufacturer located outside the EU, to act on the manufacturer’s behalf in relation to specific tasks specified in the regulation. The European Authorized Representative must be located in Europe and meet requisite qualifications that are well defined in the MDD/IVDD and MDR/IVDR. All the manufacturers shall have an Eurpean Authorized Representative which does not have nearly as many responsibilities as those assigned to the PRRC.
How to Document the Appointment of the PRRC within the Quality Management System
It is necessary to document an appointment letter where the top management authorises a specific person to act as PRRC (Person Responsible for Regulatory Compliance). In the letter, the responsibilities of the PRRC shall be well defined.
QualityMedDev provides an example of PRRC designation letter fully editable in order to modify it according to the need of your organization. Do not hesitate to download this letter from our shop.
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