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
and the German Medizinprodukterecht-Durchführungsgesetz (Medical Devices Implementation Act), chapter 6, requires you to train your
- Medical Device Consultants
– under the condition that they are consulting healthcare professionals.
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)
Under the MDR, you need a “person responsible for regulatory compliance” (PRRC)
They are defined in the MDR, article 15.:
- 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.
The MDR does not mention how the qualification should be proven. A lot of PRRCs take courses on “How to be a PRRC” and take this as proof of their experience, but such a course is not required by the MDR. Generally, a CV (and university diploma) should do the job.
- 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 responsibilities of the PRRC are specified in the MDR, article 15, but basically, the person is responsible for the products being manufactured in a compliant way, the technical documentation being complete and compliant, etc. Pretty much the definition of “this person is responsible for regulatory compliance in this company”.
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
Consider getting an external person if your company is small (49 people or less) and none of you fulfills the requirements.
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
When you hear “medical device consultant”, you probably think about hiring consultants who help you certify your software as a medical device. Well, this consultant is different. Here, “medical device consultant” refers to people who sell your products and/or instruct professional users on how to use them. So: People in your company who do sales and user training.
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
The requirements are easier to fulfill than for the PRRC. Good news! Well, someone has to sell your product and you can’t expect all of those people to be doctors and have a thousand years of regulatory job experience.
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.
Pretty simple, right? Regulatory compliance is always simple.
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.
If you’re helping lay users in understanding which button to press in order to access a certain screen, this activity does not require a medical device consultant. Likewise, if you tell people information that they could also get from the User Manual, this does not require a specifically trained medical device consultant. Only if you advise healthcare professionals (in Germany!), an MDC training is required.
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
This can be briefly summarized as: The most important tasks of medical device consultants are explaining the handling of devices to professionals and informing the PRRC if things go wrong with the device. Example situations:
- 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.
You get the idea. The medical device consultants subsequently must inform the PRRC. That’s all.
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
Congratulations for reading this article completely. Let’s grab a beer if you’re in Berlin.