The EU Medical Device Regulation (MDR) 2017/745 and the EU In-vitro Diagnostic Devices Regulation (IVDR) 2017/746 require as per Article 15, that every manufacturer of medical devices or of in-vitro diagnostic medical devices and their Authorized Representative designate one or multiple Persons Responsible for Regulatory Compliance (PRRC).
A PRRC bears a resemblance to the Safety Officer pursuant to §30 of the former German Medical Devices Act (MPG), however, it is not identical, as responsibility and relevance of the Person Responsible for Regulatory Compliance significantly exceed those of the Safety Officer.
The person responsible for regulatory compliance shall at least be responsible for ensuring that
|Compliance check of the devices?
|Technical documentation and EU declaration of conformity drawn up and up to date?
|Surveillance (PMS) performed?
|Reporting to authorities?
|Statement on clinical investigations/performance studies?
Furthermore, the MDR and the IVDR require of the PRRC a specific professional qualification.
If you are a manufacturer falling into the category of a micro or small enterprise, with an annual turnover not exceeding EUR 10 million, and employing fewer than 50 persons, we can alleviate your worry.
MDSS Consulting GmbH will be happy to provide you with one of our competent, qualified employees who will perform these tasks as external PRRC.
You can decide yourself whether we cover all areas of responsibility, or whether we should support you with only some aspects (modular assignment).
Let us find together the right solution, individually tailored to your needs.
Do not hesitate to contact us.
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