Article 15 of both the regulations the In-Vitro Medical Device Regulations (IVDR) and Medical Device Regulations (MDR) have important new requirements for hiring a ‘person Responsible for Regulatory Compliance’. With the new EU MDR 2017/745 and IVDR 2017/746, ensuring the competent personal in the right position is not only important from the business point of view but also from regulatory compliance perspective. Article 15 of the Medical Device Regulation (MDR) and In Vitro Medical Device Regulation (IVDR) makes this requirement transparent:
“Manufacturers shall have available within their organization at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices”
The Use of the Term PRRC
PRRC is just an acronym referring to the individual or the Person Responsible for Regulatory Compliance as mandated by the new EU MDR / IVDR.
The Qualifications for the PRRC
Article 15 of the MDR / IVDR discusses the qualification for the PRRC in detail. But on a simple note we have presented in a tabular form the two available options:
|>>||Option 1||Option 2|
|Education||A university degree or equivalent course of study in law, medicine, pharmacy, engineering or another appropriate scientific discipline.||N/A|
|Experience||At least one year of professional experience in quality or regulatory for medical devices||Four years professional experience in quality or regulatory for medical devices|
Note: Manufacturers of custom-made medical devices can show necessary expertise by having a minimum of two years of professional experience within an appropriate manufacturing area.
The role of the PRRC
The role of the PRRC is explicated in Article 15 of the EU MDR 2017/745. MDR mandates the manufacturers of the medical device to hire a nominated employee with regulatory proficiency to make sure compliance with the EU MDR. The PRRC is responsible for making sure:
- The compliance of the medical devices is suitably checked, in line with the quality management system (QMS) under which the devices are produced, and this should be done before the product is released.
- The EU declaration of conformity and EU technical documentation are managed and maintained with the incorporation of all the necessary updates.
- The post-market surveillance responsibilities are fulfilled consistently with the MDR requirements.
- Reporting requirements to regulatory authorities and others are well managed including those of the vigilance and analysis reporting, serious incident reporting, field safety corrective measures and the trend analysis etc.
- For the devices involved within investigation, a statement signed should be available demonstrating that the devices meet the requirements of the General Safety and Performance Requirements (GSPR).
Single or Multiple Persons to manage Responsibilities for a PRRC
As many manufacturers are concerned whether the role of the PRRC can only be managed by one person or it can be a shared responsibility where a person is looking after and the other one on the remaining. So these responsibilities can be allocated to more than one person. However all the persons sharing the role of the PRRC should meet the qualification criterion, and documentation will prepared for their roles, each of them will be specify as to who is looking what etc. This will also incorporate updated job descriptions and the organization chart also needs to be updated accordingly. In larger companies, it may be beneficial to divide this role into different product lines or it can also be divided by function.
Compliance for Small Businesses
If a company can justify herself under the classification of a ‘Micro’ or ‘Small Enterprise’, they can outsource this role, for instance to a professional consultant. But that person needs to be always at the company’s disposal and must qualify the mentioned requirements. This relationship and the allocated responsibilities should be defined within an agreement and consultant will be considered as a critical supplier to the company and should be likewise documented.
|Small Company||<50 persons||≤ Euro 10 million|
|Micro Company||<10 persons||≤ Euro 2 million|
Compliance for Authorized Representative for PRRC
Authorized Representative also needs to have the PRRC. One person should be there for the authorized representatives of the medical devices manufacturers to exhibit the role of the PRRC on permanent and continuous basis and also needs to qualify the criterion for the PRRC.
Changes to be incorporated in the QMS for PRRC
The role of PRRC should be incorporated in the QMS and also in any Post market surveillance and vigilance activities for the devices they PRRC is taking care of. The PRRC should authorize the final product release.
The Registration of the PRRC
The PRRCs will have to register with their name and office address along with the registration of the medical device company (whether authorized representative or the manufacturer). This information must be updated whenever modifications are incorporated. Another important discussion here is the individual looking after the regulatory compliance as the PRRC must not be poorly paid, or professionally disturbed to fulfill the assigned responsibilities. This is applicable to both parties serving as the PRRC i.e. the employee or the consultant.
One final recommendation for the companies looking forward to the MDR compliance, one needs to identify the person for your company to serve the role of the PRRC, if your company hasn’t done yet, it is high time to do it and once it is resolved, the QMS should be tailored accordingly with this change. It will help the company with a smoother transition for the MDR or the IVDR.
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