Responsible person acc. Article 15 MDR

What does “Responsible Person” mean?

Both the MDR and the IVDR require a “Person Responsible for Regulatory Compliance” (PRRC). Some also speak of an “Article 15 person” (after the corresponding articles in the two EU regulations) or of the “Qualified Person”. The PRRC has similarities with the safety officer, but is not congruent, as the responsibility and importance of the responsible person (VP) go far beyond those of the safety officer.

Does your company need a VP?

Article 31 in conjunction with Annex VI, Part 1, Paragraph 1. or 1.4 states that “manufacturers or, where applicable, their authorized representatives and, where applicable, importers” shall provide the “name, address and contact details of those responsible for regulatory compliance Person(s) according to Article 15” must be registered in EUDAMED. The EU stresses that the person responsible for regulatory compliance CANNOT be the EU envoy. The VP must be close to the manufacturer, i.e. be based in the EU for an EU manufacturer and outside the EU for a non-EU manufacturer. Manufacturers are therefore well advised to fill this role with qualified staff as quickly as possible in order to meet regulatory requirements, ensure the safety and conformity of their products and avoid painful penalties.

How long do you have to name this person?

There are no transitional periods. The general opinion is that the VP must be implemented from May 25th, 2020. This also applies if the manufacturer still puts his products on the market under the guidelines (MDD) within the transition period.

What tasks and responsibilities (here are some examples) does the VP have?

• Conformity of medical devices
• Updating of the technical documentation
• Market surveillance compliant with EU directives
• Reporting obligations in accordance with EU directives​
• As a rule, the RP is not personally liable in cases of simple negligence. In the event of gross negligence, the manufacturer can take recourse against its employees.
• A limitation of liability or an exemption agreement can be included in the employment contract with the RP.
• In the case of gross negligence and intent, such an exclusion is neither sensible nor possible. There are also criminal consequences.

What competencies (here are some examples) does the RP have?

• University degree or recognized degree in law, medicine, pharmacy, engineering or other relevant scientific discipline AND at least one year of professional experience in the field of quality management or regulatory affairs
• This professional experience must relate to medical devices.

or

• Four years of professional experience in the areas of quality management or regulatory affairs.
• This professional experience must relate to medical devices
• For manufacturers of custom-made products, the EU regulations allow proof to be provided with just two years of professional experience.
• The degrees must be clearly documented. In terms of professional experience, manufacturers should be able to provide evidence of one or more of the following:
• Employment contract stating that and since when the person is working in regulatory affairs or quality management
• Organizational chart showing this role
• Proof of training in the areas of quality management, medical device law, market surveillance, risk management, reporting
• Records such as audit reports and document approvals
• Report of the person to DIMDI as safety officer

What happens if your company does not employ a suitable person?

Manufacturers must have this “Person Responsible for Regulatory Compliance” within their organization. However, the MDR allows exceptions for micro and small companies. Nevertheless, they must also be able to “permanently and constantly fall back on such a person.” This access must be contractually regulated.

Do you have further or more detailed questions?