Maintaining compliance to the Eurpoean regulations can be confusing, difficult and time consuming, especially since the release of the EU Medical Device Regulation (2017/745) and In Vitro Diagnostic Regulation (2017/746). With the new regulations, it is incumbent upon companies to always have a qualified regulatory expert at their disposal to ensure the company is meeting EU requirements.
Therefore the new role of the Person Responsible for Regulatory Compliance (PRRC) was created. And within Article 15 of the MDR and IVDR the mandate for the appointment of a PRRC for all Medical Device and In Vitro Diagnostic manufacturers is called out, along with additional guidance within the MDCG 2019-7.
Here at Norway Health Tech we would like to give guidance on the regulations and have put together the following information to give you clarity on what is required both in qualifications and responsibilities of the PRRC.
What are the qualifications of the Person Responsible for Regulatory Compliance?
According to the MDR and IVDR the PRRC must have:
- 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;
- four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
Additional guidance from the MDCG 2019-7:
The PRRC must have:
- requisite expertise in the field of medical devices, and
- university degree, diploma, or some other formal qualifications, and
- at least one year of experience in European regulatory affairs or quality systems management related to medical devices,
- OR…if no university degree, diploma, or other qualification, they must have four years of professional experience in European regulatory affairs or quality systems management related to medical devices.
What is the Person Responsible for Regulatory Compliance responsible for?
According to Article 15(3) 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;
- 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 Article 10(10);
- the reporting obligations referred to in Articles 87 to 91 are fulfilled;
- in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.
To get a better understanding of the above responsiblities the guidance document, MDCG 2019-7, has given further detail:
- Manufacturers “of devices, other than investigational [performance study] devices, shall establish, document, implement, maintain, keep up to date and continually improve a quality management system that shall ensure compliance with this Regulation in the most effective manner and in a manner that is proportionate to the risk class and the type of device” (Article 10(9) of the MDR and Article 10(8) of the IVDR).
- Manufacturers “[of devices other than custom-made devices] shall draw up and keep up to date technical documentation for those devices” (Article 10(4) of the MDR and IVDR) and “shall draw up an EU declaration of conformity” (Article 10(6) of the MDR and Article 10(5) of the IVDR).
- Manufacturers “of devices shall implement and keep up to date the post-market surveillance system” (Article 10(10) of the MDR and Article 10(9) of the IVDR).
- Manufacturers “shall have a system for recording and reporting of incidents and field safety corrective actions as described in Articles 87 and 88” (Article 10(13) of the MDR and Article 10(12) of the IVDR).
- Manufacturers shall ensure that “a signed statement by the natural or legal person responsible for the manufacture of the investigational device [for performance study] that the device in question conforms to the general safety and performance requirements apart from the aspects covered by the clinical investigation [performance study] and that, with regard to those aspects, every precaution has been taken to protect the health and safety of the subject.”
Still confused??? Here at Norway Health Tech Academy we are offering a seminar series for companies and individuals to gain better understanding and knowledge for what the role of the PRRC entails and what that means for your company. Please join us on the 19-21 of January 2021 for our PRRC Workshop – Beginners and the 16-18 of February 2021 for our PRRC Workshop – Advanced. In the meantime if you have any questions please feel free to contact me, Kami Faust the Regulatory Advisor at Norway Health Tech.