People You Need: Person Responsible for Regulatory Compliance and Medical Device Consultants
When you’re becoming a medical device manufacturer in Germany, there are two sorts of people you need. The good news is that you don’t need to employ all of them. But let’s start from the beginning.
The MDR requires you to have
- A person responsible for regulatory compliance
- Medical Device Consultants
If you’re not selling your products in Germany, there is no need to train medical device consultants. Anyway, let’s look at each of those roles.
Person Responsible for Regulatory Compliance (PRRC) (MDR)
PRRC Requirements
- Each company needs at least one.
- You have to register this person with the authorities (not defined in MDR, but will probably be required per country).
- The person needs to be qualified, either by having a University degree in law or scientific, medical or technical field and at least one year of job experience in the regulatory field or quality management systems. Or: Four years of job experience in the regulatory field or with quality management systems.
- Companies with 49 employees or less and less than 10 million € annual turnover can have an external person for this, otherwise, it must be an employee.
- The PRRC is responsible for various things, e.g. whether the products are manufactured in a compliant way, based on the quality management system; whether technical documentation is complete and up to date.
- The PRRC must not be put at a disadvantage in the company.
Some examples:
- Someone who is a physician and has worked as a regulatory affairs manager in a Healthcare company.
- Someone who hasn’t got a University degree and who has worked as a clinical evaluation manager in a regulatory affairs department at a medical device manufacturer.
PRRC Tasks & Responsibilities
The PRRC can also be an external person (e.g. a consultant) if the company has 49 employees or less.
Other than that, more detailed information on this can be found in the MDCG guidance 2019-7.
Finding a PRRC
Certainly not the easiest read. Congratulations on reading this far. The last and final person is rather straightforward, so you’re almost done!
Medical Device Consultant
Practically speaking, that means that you’ll have more than one of those in your company, and most likely they’ll all be your employees.
That’s defined in the German MPDG §83. We’ll look at some more examples later on, but let’s first look at the requirements for this position.
Medical Device Consultant Requirements
Specifically, the requirements are:
- Anyone who informs “expert groups” in handling medical devices is a medical device consultant and must be qualified (see next point).
- The person is trained in a scientific, medical, or technical field (not necessarily a University degree) and has received training regarding the medical devices he or she will be working with. Or: The person has worked with those medical devices for one year and has received training in how to handle them, if necessary.
- That knowledge has to be updated regularly.
- The medical device consultant must keep track of events that may pose risks to users / patients and forward them to the PRRC.
So what does that mean for your company? Any person who sells your device or informs healthcare professionals (typically doctors, nurses, healthcare technicians, …) how to handle it is by definition a medical device consultant. Examples could be:
- You’ve developed a new device for surgeries. Your sales team approaches surgeons and tells them for which surgeries the device can be used. They are acting as medical device consultants.
- One of your product managers conducts training for professional users of your medical software. That product manager is acting as a medical device consultant.
Okay. And how do those poor people fulfill the requirements for being a medical device consultant?
- By having proof of their job training / degree. By the way, you always need proof for those degrees.
- And by being (regularly) trained by your company regarding the medical devices they’ll be handling. Like always, you need proof for that, e.g. attendance signatures from your internal training seminars. Fun!
Medical Device Consultant Tasks
- A customer calls and complains that the software regularly makes their mobile phones explode.
- A user sends an email that their user profile data got swapped with someone else’s profile and now their disease data is all mixed up.
Thinking along these lines, if your customer support agents give advice on the handling of devices to expert groups, they should be trained as medical device consultants, too.
Conclusion: Lots to do
On a different note: Do you need any help with your EU MDR efforts?
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Dr. Oliver Eidel
Through OpenRegulatory, I’ve helped 100+ companies with their medical device compliance. While it’s also my job that we stay profitable, I try to dedicate a lot of my time towards writing free content like our articles and templates. Maybe that will make consulting unnecessary some day? :)
If you’re still lost and have further questions, reach out any time!