负责注册的人ulatory 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. As the European Union’s (EU) Medical Device Regulation (MDR) and In-Vitro Diagnostic Medical Device Regulation (IVDR) continue to evolve, one requirement is getting a lot of attention – the person responsible for regulatory compliance (PRRC).
This individual (or individuals) is one of the newly introduced requirements of the MDR/IVDR and their presence is to ensure that companies have a qualified regulatory expert at their disposal. If a company consists of more than one legal manufacturer, each legal manufacturer must appoint its own PRRC. Both the MDR and the IVDR require a “person responsible for regulatory compliance”(PRRC).
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负责注册的人ulatory Compliance does not replace the European Authorized Representative (EC Rep). However, the two roles are symbiotic. As you know, your EC Rep must be located in Europe and meet requisite qualifications that are well defined in the MDD/IVDD and MDR/IVDR. The EC Rep’s name and address must appear on labeling. However, the EC Rep does not have nearly as many responsibilities as those assigned to the Person Responsible for Regulatory Compliance.
Who can be a PRRC?
The MDR and the IVDR calls for a person possessing the requisite expertise in the field of medical devices, which is defined as qualifications that are demonstrated by either:
A diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognized 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.
While formal qualification is easily documented with a diploma or certificate, professional experience in medical device regulatory affairs or in quality management systems (referring to experience gained in the EU) has to be demonstrated as well. Qualification based on professional experience has to be substantiated with documents such as a work contract, organization chart, training evidence or internal records such as document releases.
PRRC资格
The EU MDR, as well as the new IVDR, define the requirements of the Person Responsible for Regulatory Compliance. Article 15 of the MDR outlines these requirements as:
- A diploma, certificate or other evidence of formal qualification, 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.
The role of the person responsible for regulatory compliance (PRRC)
The role of the Person Responsible for Regulatory Compliance is defined in Article 15 of the EU MDR (2017/745). MDR requires medical device manufacturers to appoint a designated employee with regulatory expertise to ensure compliance with the EU MDR. The PRRC is responsible for ensuring that:
- The conformity of the devices is appropriately 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 manufacturer require a PRRC?
The mandate to appoint a Person Responsible for Regulatory Compliance depends on the size of your organization. The MDR provides an exception for small manufacturers. Medical device manufacturers with fewer than 50 full-time employees (globally)andunder 10 million Euros in global sales revenue (not just EU) are not required to have a Person Responsible for Regulatory Compliance within the company. However, these small manufacturers can outsource the role but are still required to “have such person permanently and continuously at their disposal.” It is also important to note that the Person Responsible for Regulatory Compliance requirement even encompasses low-risk devices.
What are the responsibilities ofPerson Responsible for Regulatory Compliancerole?
- Checking that the device conforms to the manufacturers QMS prior to release
- Verifying that the technical documentation and EU declaration of conformity are properly implemented and maintained
- Managing and ensuring that post-market surveillance obligations are complied with; including post market surveillance plan, post-market report and periodic safety update report as applicable
- Ensuring that the reporting obligations are fulfilled for serious incidents, field safety corrective actions and trend reporting
- The statement referred to in Section 4.1 of Chapter II of Annex XV is issued in the case of investigation devices.
Who should employ a Person Responsible for Regulatory Compliance?
Micro and small companies should have permanent and continuous access to the services of such a person. The service can be outsourced. Larger companies should have such a person within their organization.
The requirements for the person responsible for regulatory compliance differ depending on the type and size of the economic actor and the role. With the persons responsible for regulatory compliance, the MDR and IVDR have introduced a role whose responsibility and importance goes far beyond that of the safety officer.
