This is a guest post by Caroline Jung of MT Promedt Consulting GmbH from Germany, a partner of Stendard.
Part 3 of our 6-part series highlighting the main points of the MDR to take note of, in light of legislation and new regulatory requirements.
The new MDR (EU) 2017/745 does not only place requirements on the manufacturers, and other economic operators. The new regulation is creating new jobs as well!
In our previous post, we mentioned that Article 15 of the MDR (EU) 2017/745 introduces a new requirement: the appointment of a Person Responsible for Regulatory Compliance (PRRC).
Who needs a PRRC?
By May 26th 2020, manufacturers shall have available within their organisation at least one PRRC who possesses the requisite expertise in the field of medical devices.
Furthermore, it should be noted that a PRRC is also required for Authorised Representatives according to Article 15(6). For non-European manufacturers, their authorised representative shall have permanently and continuously at its disposal at least one PRRC who possesses the requisite expertise regarding the regulatory requirements for medical devices in the Union.
Exemptions are considered especially for Micro (with less than 10 employees) and Small enterprises (with less than 50 employees). They shall not be required to have the PRRC within their organisation. Still, they must have a PRRC permanently and continuously at their disposal. In such cases, this role can be taken over by an external person, as for example a consultant.
Who can be a PRRC?
Qualifications are definitely important, given the nature of work to be done. The regulation describes in Article 15 the qualification requirements as following:
“a requisite expertise has to be 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 recognised 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.”
These qualifications must be proven by demonstrated member state equivalency, meaning that your company will need to check the recognition of any non-EU diplomas by member states and document this for the PRRC.
Knowing who can be also means knowing who cannot be.
The PRRC for the Authorised Representative must not be located outside the EU because the Authorised Representative is located in the EU and the PRRC should be permanently and continuously at its disposal – this is not an explicit requirement in the MDR, but has been clarified in a recent guidance document published. The PRRC for the manufacturer can, however, be located outside the EU.
Separately, the PRRC for the Authorised Representative cannot be the PRRC for the manufacturer as well. Although this is not explicitly stated in the regulations, it is evident that with the increased supervisory role of the Authorised Representative, having one person carry out both roles would create a conflict of interest.
Micro and small enterprises who might subcontract the responsibilities of the PRRC to an external party must further note that their PRRC cannot be the same person, or belong to the same organisation as the PRRC of their Authorised Representative.
What are the responsibilities of the PRRC?
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) of the MDR (EU) 2017/745;
the reporting obligations related to serious incidents, FSCAs and trends as referred to in Articles 87 to 91 of the MDR (EU) 2017/745 are fulfilled;
in the case of investigational devices, the statement that the device in question conforms to the general safety and performance requirements apart from the aspects covered by the clinical investigation and that, with regard to those aspects, every precaution has been taken to protect the health and safety of the subject as it is referred to in Section 4.1 of Chapter II of Annex XV of the MDR (EU) 2017/745 is issued.
*According to our interpretation, the first responsibility of checking the conformity of the devices, is an organisational responsibility, not an operational responsibility. This means that the PRRC has to make sure that a system for a batch release/product release is available, for production and testing to be done according to specifications defined within the company’s quality management system.
You should still note that this section could also be interpreted that the PRRC is personally responsible for the batch release, which would mean an adaptation of the concept of the Qualified Person in the GMP environment. It will be interesting to see how the different Notified Bodies are going to interpret this section.
What should I do?
As the MDR allows to appoint more than one PRRC, it is possible for you to split the responsibilities of the PRRC among different responsible persons in different departments within the company, or externally. Please make sure that each appointed PRRC (including the deputies) has the qualifications as required by the regulation. Importantly, each PRRC has to be registered in the EUDAMED database when it is available. Stendard is one who can provide such third-party PRRC support.
Within your organisation, it has to be understood that the PRRC(s) shall suffer no disadvantage in relation to the proper fulfilment of his or her duties, whether or not they are employees of your organisation. This is a concept which is already applicable to Safety Officers who are required in Germany and Austria under the existing national medical device laws. We expect that Notified Bodies will look into evidence of the PRRC(s) qualifications and will check for training programmes to ensure their staying informed about European regulatory requirements. You simply need to make sure that your process on Standard Control is appropriate.
Steps to take: How to appoint a PRRC?
We recommend you to prepare or perform the following action:
Draft a Job Description
Create a Letter of Appointment for each PRRC
Update your Organisational Chart
Update all relevant QM documentation (SOPs, working instructions, forms) regarding the new requirements and responsibilities of the PRRC
If an external PRRC is appointed, an agreement with this external person has to be established; this service provider should be considered a “critical supplier”
Register your appointed PRRC(s) as soon as the EUDAMED database is operational
While evident that the MDR (EU) 2017/745 contains new requirements, which brings challenges, these adjustments to be made can be manageable when tackled systematically. Having this proper system, with tighter regulations, can help enhance patient safety.
The pointers described above will also be relevant for manufacturers of IVD-Medical Devices who will have to comply with the new IVDR (EU) 2017/746. From May 26th 2022, IVD manufacturers have to appoint a PRRC as well.
It is timely to take action now, given support at hand. Earlier this week, the Medical Device Coordination Group (MDCG) released one new guidance on PRRC(s). Take a read and understand more as you look to appoint your PRRC, and see how Stendard is able to fulfill these role: MDCG 2019-7 Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a "person responsible for regulatory compliance" (PRRC)
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