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

  • 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;
Compliance check of the devices?
  • the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
Technical documentation and EU declaration of conformity drawn up and up to date?
  •  the post-market surveillance obligations are complied with in accordance with Article 10(10) (MDR) or Article 9 (IVDR);
Surveillance (PMS) performed?
  • the reporting obligations referred to in Articles 87 to 91 (MDR) or respectively Articles 82 to 86 (IVDR) are fulfilled;
Reporting to authorities?
  • in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued (MDR), and in the case of devices for performance studies intended to be used in the context of interventional clinical performance studies or other performance studies involving risks for the subjects, the statement referred to in Section 4.1 of Annex XIV is issued (IVDR).
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.

PRRC and EC REP Maintenance agreement

Click here for label example

For Manufacturers who have or want to set up a subsidiary in the European Union

  • You are the Manufacturer
  • You are the Importer
  • You are the EC REP (maintained by MDSS Consulting GmbH)

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