Person responsible for regulatory compliance – Article 15 MDR / IVDR
When it comes to the MDR / IVDR, ensuring the right people are in the right place is all important no more so than with regulatory compliance. Article 15 of both the Medical Device Regulation (MDR) and the In Vitro Medical Device Regulation (IVDR) makes this requirement crystal clear:
“Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices”
Below are some of the questions I frequently get asked about this role.
What is a PRRC?
This is the acronym that has been adopted by industry for referring to the Person Responsible for Regulatory Compliance as detailed in the EU MDR / IVDR. Just roles off the tongue doesn’t it!
What qualifications are needed?
Article 15 of the MDR / IVDR goes into more detail but put simply you have two options:
- A university degree or course of study in law, medicine, pharmacy, engineering or another relevant scientific discipline and 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: that manufacturers of custom-made devices can demonstrate requisite expertise by having at least two years of professional experience within a relevant field of manufacturing
What are the responsibilities of a Person Responsible for Regulatory Compliance?
- checking the conformity of the devices in accordance with the quality management system (QMS) before release
- Preparing and maintaining the technical documentation and EU Declaration of Conformity
- Meeting post market surveillance obligations
- Vigilance reporting and analysis requirements are met including serious incidents, field safety corrective actions and report trending, and
- For investigational devices a signed statement that the device meets the GSPRs
Can more than one person fill the role of a PRRC?
Yes – the responsibilities can be assigned to more than one person. You will just need to document who those people are, how they are qualified for the role and what exactly they are responsible for. This will involve updating job descriptions and your company organisation chart. In larger organisations it may be useful to split this role up into product lines or by function.
I’m a small business and don’t have dedicated personnel for QA /RA how can I comply?
If you fall under the definition or a ‘Micro’ or ‘Small Enterprise’ (as per 2003/361/EC) you can outsource this role, for example to a consultant, BUT that person must be permanently and continuously at your disposal and must meet the required qualifications. This relationship and the agreed responsibilities should be clearly defined within an agreement and they will be deemed a critical supplier to you and should be documented as such.
I checked the definitions at the time of writing this post for a micro or small enterprise and found the following:
|Company Category||Staff headcount||Turnover OR Balance Sheet Total|
|Small||<50||≤ €10 m|
|Micro||<10||≤ € 2 m|
Be aware though that if your company belongs to larger group you may need to include the staff headcount / turnover / balance sheet data from that group too.
I’m an EU Authorised Representative – does this apply to me?
The answer is simply – yes. As an Authorised Representative you also must have at least one person ‘permanently and continuously at your disposal ‘responsible for regulatory compliance with the same qualifications.
What other updates will I need to make to my QMS for this role?
The PRRC should be included in any vigilance and PMS activities for the devices they are responsible for. They should complete final product release.
The PRRC(s) will need to provide their name and work address with the registration of your company (manufacturer or AR). It is important that this information be kept up to date when changes are made.
Another point worth noting is that the person responsible for regulatory compliance should not be financially or professionally disadvantaged for properly fulfilling their duties, whether or not they are employees of your company or are contracted to it.
One final piece of advice is, if you haven’t already done so, identify who within your company is going to take on these responsibilities and get making the changes to your quality system now. This will make the transition a lot smoother.
For further information please get in touch
Telephone: +44 (0)1295 724286