With the new EU MDR 2017/745 and IVDR 2017/746, you cannot say that a new regulation is not creating new jobs. Because by May 26th, 2020 you should have a new function on your organizational chart, the PRRC.
This acronym is for Person Responsible for Regulatory Compliance and you can find all the information about this function on article 15 of both regulations.
This reminds me of when I worked in the Pharma industry. There was the “QP or Qualified Person”.
I am quite sure that the PRRC was inspired by that.
Why would you read this article:
- The Person Responsible for Regulatory Compliance will be mandatory so have you already thought about the best person on your organization to fulfill this role?
- Do you even have a person that has the qualification to be appointed as a PRRC?
- Do you know how to appoint a PRRC to be compliant during an audit?
You are at the right place if you want to learn more about this new function.
One other question you would maybe ask is about the difference between the PRRC and the Management Representative (Requirement of ISO 13485).
I will also provide you with the differences and how you can manage that within your organization.
And to help you succeed on this journey, I also decided to create some documents, free to download.
Check below. More details about these templates are on the article.
At the end of this article, I created a quiz to see if you understood all the requirements for a PRRC.
So let’s review a bit more about this function and who can be a PRRC.
Question for you
At the end of the article, I will also have a question for you. Please let me know your answer in the comments.
Video to introduce the PRRC role
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Table of Contents
Who can be PRRC ?
To be Person Responsible for Regulatory Compliance on your organization there are 2 options.
Which one will you choose?
- You have the right diploma, and
- You have 1 year of experience in regulatory affairs or quality management systems on medical devices.
What kind of Diploma is required?
There is no fix choice but it should be a diploma in:
- Another Scientific Discipline
And for the experience, it is 1 year in Regulatory Affairs or in Quality Management System on Medical Devices.
But I suppose that it’s not mandatory to be a manager role.
The interest of all this is to have a person that is competent and know what we are talking about.
Remember that Medical Devices are saving lives so it’s quite important to have someone that is qualified to take care of the job.
I’ll tell you after what will be its roles and responsibility.
Note: if you have a pharma diploma but no experience in medical device, I would recommend you to justify if your pharma experience is equivalent to a medical device industry.
They are both in a regulated environment but the requirements are different. But try to prove that you are knowledgeable by also performing a training on Medical Device Regulatory Compliance.
The wording is saying specifically Medical Device experience, so an auditor can really challenge you. So put everything on your side to prove that you are really credible regarding this specific regulation.
We understand that some people learned everything directly when they started their professional careers.
So you can also become PRRC if you have 4 years of experience in Regulatory Affairs or in Quality Management System on Medical Devices.
It’s true that someone that survived 4 years in this function had enough time to get the experience and make mistakes. So congratulation. You can already mention your name to your boss if you want to become a PRRC.
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What if no one is qualified to be PRRC?
In that case, there are 2 choices:
- Hire a new employee that will fulfill this role
- Hire a consultant for a certain period of time until one of your internal employees gets trained.
In fact, in case the candidate you would choose for a PRRC has only 2 years of experience in the industry but no diploma, you can still offer him a training so he can learn what is the role of a Regulatory Compliance person.
But this should not be only a 1-day training as you can see sometimes which are more here to tick a box than to really learn. You really need to have performed a training that is showing some theoretical part and some practices.
The auditor can challenge you regarding the content of that training.
However, you need to start that before the EU MDR is in place. So put a strategic development plan to one of your employees to be ready on May 2020.
Micro and small enterprises
I know, I know.
I already hear some CEOs of micro and small businesses who are saying that they don’t have this kind of person available at their site.
So what to do? Do you need to budget this PRRC?
No, the EU commission heard you also and they said that for Micro and Small enterprises they still need to have a PRRC but not within their organization.
This role can be with a consultant for example, but, there is a but. This person should be “Permanently” and “Continuously” at the disposal of these enterprises.
I know it can be confusing.
What does mean “Permanently” and Continuously” if they are not part of your organization?
It means that as soon as you need this person, it should be available for you. I only suppose that we are talking about office hours. Because asking someone to be available continuously can cost a lot.
This service can be a good business for some consulting organizations if they have the right persons available on their team.
Or maybe a lot of new 1 person organizations will be created to fulfill this requirement.
So, start to look now for this kind of person if you are a Micro or Small enterprise.
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Special case for Custom-made industry
For companies that are manufacturing custom-made devices, there is a difference in terms of qualification.
For option 1 (Diploma + Experience), the only change is regarding the experience.
The person applying for PRRC should have 2 years of experience in the area of the industry. But in case it has 4 years of experience in this industry, it is sufficient.
It’s clear that custom-made devices are another category with some specific requirements. So having a person that is only knowledgeable on mass production industry can be confusing.
On MDR, the requirements for Custom-made devices are available on Annex XIII.
Do we need also a PRRC for an Authorized Representative?
The answer is Yes.
The Authorized Representative is representing the manufacturer in Europe when he is located outside of Europe.
So he needs to have a PRRC person working with him.
What is the rule regarding the PRRC at an Authorized Representative?
It is exactly the same as for Micro and Small Enterprises. He can be part or not of the organization but similarly, he needs to be permanently and continuously available.
For the qualification it is the same:
- Option 1: Diploma + 1 year of experience
- Option 2: 4 years of experience
What is the role and responsibility of the PRRC?
Good question. Thanks for asking. The Person Responsible for Regulatory Compliance has an important role in the compliance of the organization.
Here are its tasks:
- Conformity of the device to the Medical Device Regulation and Quality Management System
- Conformity of the Technical Documentation and EU Declaration of conformity
- Compliance with Post-Market Surveillance (PMS) following Article 10(10)
- Compliance with the Vigilance Reporting obligations (Article 87 to 91)
- For Investigational devices: Issuance of a signed statement (Annex XV Chapter II Section 4.1)
One important thing also is the fact that this person should be independent to exercise his authority. It means that he should not get pressure to decrease the importance of compliance or to let pass some issues. Without that, he will not be really able to perform his job correctly.
Below, I have prepared an information for each tasks of the PRRC. So I hope this will help you to stay compliant.
How to verify the conformity of the device?
Now that you are appointed as a PRRC, you maybe ask yourself how you will exectue some of these tasks. For example, how will you check that the product that is released is compliant to the legislation. Do you need to stay at the end of the production line and put a stamp on each of them to say that you have reviewed and approved? No.
The aim of this responsibility is for you as PRRC to verify that there is a process in place within the Quality Management System to identify good and bad products. The objective is also for you to confirm that the people that are executing this task are trained and that the product is checked and verified (Product, label, packaging…) prior release.
An auditor can ask you to see your Product Release procedure and if you are the one signing it, this may also give a sign that you were working on this process which show your involvement as a PRRC to be sure that this is fine.
How to verify that the Technical Documentation and Declaration of conformity are ok?
In this situation, the job might be tricky. If you have only 1 technical documentation to review this should be feasible. If you just got appointed and there are 40 technical documentations, then you may need some time to review them.
You can also decide to do some sampling like what the Notified Body is doing. You may also include this within the internal audit program…
The PRRC should review that the Technical Documentation and the Declaration of Conformity exist and that they are up-to-date. You may sign them also but this is not required by the regulation. So you choose what to do.
Same as for the previous one, you may also think of reviewing the process to create Technical Documentations and the Declaration of Conformity. And if you sign it this may show that you are involved.
Are the Post-marketing surveillance obligation fulfilled?
So the PRRC should read carefully article 83 to 86 (MDR) or article 78 to 81 (IVDR) to then being able to support this requirement. So normally, every year the company is supposed to check the situation of the products on the market. The review of complaints, vigilance, issues, feedback, new test reports, PMCF… will help you build the PMS report for Class I or PSUR for other product classes.
Same as for the other responsibilities, if you as a PRRC can be involved on this process as a person signing the documents this may help a lot. If you are also able to sign and approve the procedure for PMS this may also show that you have worked to build the process.
With that the Notified Body will be happy.
Vigilance reporting responsibility
This role is important. The others were more checking that all is good before there is an issue. Here we are asking the PRRC to act while the problem happened.
When you work for medical device manufacturers, you should have a process for reporting any issues. Not only for MDR, IVDR but also for FDA, Brazil, Canada… Any country is asking you to alert them when you have identified a problem.
In this case, the PRRC should also be involved and confirm that the Vigilance reporting requirements are fulfilled when this is needed. So as a PRRC, if you CEO says that this is a minor issue and that there is no need to report this to the authorities, but you think the contrary, then your independancy should allow you to report.
This is also the case if you start to see a trend. As mentioned on article 88 (MDR) or article 83 (IVDR) any trend should be analyzed and reported. So don’t forget that.
What to do if there is a Clinical investigation or performance study?
The PRRC should also verify that the rules defined in EU MDR and IVDR are respected when a product is going through a clinical investigation or performance study.
The rule is that the company should issue a statement to declare that the device is complying to the General Safety and Performance requirements (Annex I).
So this is the only task to do. No need to follow the study or check the result or visit the patients… You just need to confirm that the statement has been created.
Again if you are involved on the process by signing the procedure or the statement this may provide some evidence that you are responsible for it. But not mandatory.
What is the difference with the Management Representative?
You know that if you are certified ISO 13485, you need to appoint a Management Representative?
What is interesting is the fact that there are no specific requirements in terms of qualification for this role.
On the ISO, only what they have to perform is defined.
But what is then the difference with the Person Responsible for Regulatory Compliance?
Role of the Management Representative
The Management Representative should be appointed by Top Management and among other activities, he should check that:
- Procedures for the Quality Management System are documented
- Report to Top Management about the effectiveness and improvement to provide to the QMS.
- Promote the awareness of applicable regulations and Quality Management System requirements throughout the organization
So now, looking at this I have a solution for you.
Instead of appointing a Management Representative and a PRRC maybe you can have 1 person performing both.
For small businesses, this is maybe possible as usually, an employee is wearing many hats.
For big organizations which are more segmented, it’s maybe more interesting to keep the Management Representative role with the quality department and the PRRC role with Regulatory Affairs Departments.
But this strategy should be defined by each company. There is no rule on that.
If you ask me, my preferred strategy is to have one person performing both roles as both are to check that everything is compliant within your organization.
Appointment of the Person Responsible for Regulatory Compliance
Similar to the Management Representative, there are multiple actions to do for you to appoint the PRRC.
Here are 3 of the main actions:
- Create a Letter of Appointment
- Draft a Job Description
- Update the Organizational Chart
Let’s review each of them. And as a present, I will offer you 3 templates. One for each.
Letter of appointment
This letter should mention the name of the PRRC and who appointed him. The person that appointing the PRRC should be from the Top Management. A CEO for small enterprises, or an Executive Director or VP for big companies.
Each time this person change, you then will need to sign a new letter. Similar as for the Management Representative.
Free to download Letter of Appointment
PRRC Letter of Appointment template
The letter will not be sufficient. You also need to have a job description.
And here, there are 2 choices.
- Specific PRRC job description
- PRRC roles and responsibility on another Job Description.
- Or include everything in the letter.
You maybe have a big organization with many roles and you don’t want to assign this function specifically to one role. In that case, you can create a specific Job description for “PRRC and Deputy”. So the person that will be PRRC will also have another job description for its principal role.
But in the case of small companies where maybe there is only one role that can be PRRC (Quality Manager or Regulatory affairs Manager for example), you can include the roles and responsibility of the PRRC on their already existing Job Description.
If you prefer, you can write all the requirements for the PRRC on the letter of appointment. But in case you want to add more requirements from your side, you’ll need to recreate and sign a new letter.
But if you have a Job Description for it, you can only change this one on your quality system.
This is really up to your organization to decide how to have this available.
BONUS: The template I will provide you below is only a guide and you should still customize it. To help you know the best practice to write a Job Description I did find this article for you: How to write a good job description
Free to download Job Description
PRRC Job description template
If you have a Quality Manager that is already management representative and now gets the function of PRRC then the title is too long for the organizational chart. So what to do.
An advice is to write only its principal title:
- Quality Manager
And put a (1) and (2) in “superscript “behind it. On the bottom of the organizational chart you can then mention what means those numbers:
- (1) Management Representative
- (2) Person Responsible for Regulatory Compliance
Free to download Org Chart
PRRC Organizational Chart
Hiring a consultant as PRRC
In the case you want to hire a consultant as your PRRC because your company has less than 50 employees and get less than 10 Million € of turnover, then Easy Medical Device is proposing you a template for an agreement.
This will define the roles and responsibilities of both parties.
Check that below
How to become the best PRRC ever?
This may sound strange, but PRRC is not only a role within an organization, it is also a beahvior, a figure of authority. So if there is something wrong within your organization you should be able to identify it and alert.
We talked about how to become the best PRRC ever with Ronald Boumans. Check that here.
During an Audit
What happens during an audit. Similar to the Management Representative role, the auditor can request to see the letter of appointment of the PPRC.
They can also request to see the Job description and at the same time, its qualification. So my advice is to collect already its diplomas or CV for the experience and have them available at any time.
Remember that you have the possibility to be audited any days of the year. During unannounced audits, this can be also a request to see these qualifications.
So you can already prepare a folder with all those elements and avoid the struggle to have to go back home to pick them up.
Can a PRRC go to Jail?
This is one of the question that was asked to the association Team-PRRC. Have a look at the answer as there may be some differences from one country to the other. Elem Ayne, the President of Team-PRRC accepted to talk about that on the podcast.
PRRC and Quality Management System
As you’ve seen on the responsibility of the Person Responsible for Regulatory Compliance, there are some requirements to check key procedures.
To be able to prove that this PRRC has made this check, you are forced to change some of your quality documents.
For example, you should maybe ask him to sign the EU Declaration of conformity. So its template and procedure should then be updated to include this requirement.
For vigilance reporting, you will also need to include the PRRC on the process so he can check that this was done correctly.
For any company, they will need to change their procedures to include this new role. My advice will be then to review each of its responsibility and review each of the procedures linked to it.
Here are for me the minimum but this also depends on your own processes so you can add more to this list:
- Product conformity
- EU declaration of conformity
- Technical Documentation
- Post-market Surveillance
- Vigilance reporting
- Investigational device
Test your knowledge
I prepared few questions for you.
Read the boxes below with the question and then put the mouse or click on it to see the answer.
It’s also linked to the chapter related to this question if you need to look at it again
Questions? Click the button below to chat with me.
Question for you
The PRRC or Person Responsible for Regulatory Compliance is now a new role within your organization.
So after reading this article, I have a question for you.
What is on the list of qualification needed, the most difficult criteria for you to find your “Person Responsible for Regulatory Compliance?
Let me know on the comments so I can find the answer for you.
More to read
Below is the link to a position paper issued by BSI group. This is providing more details on the PRRC role. Don’t hesitate to download it.
Medical Device expert. Monir founded Easy Medical Device to help Medical Device companies to place compliant products on the market. He proposes his consulting services so don’t hesitate to contact him at email@example.com or +41799036836
My objective is to share my knowledge and experience with the community of people working in the Medical Device field.