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Updated June 22, 2023

People You Need: Person Responsible for Regulatory Compliance and Medical Device Consultants

Sören Hornof

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

  1. A person responsible for regulatory compliance

and the German Medizinprodukterecht-Durchführungsgesetz (Medical Devices Implementation Act), chapter 6, requires you to train your

  1. 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)

PRRC Requirements

They are defined in the MDR, article 15.:

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.

Some examples:

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:

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:

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?

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:

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.

On a slighty different note: You want to get your medical software certified under MDR but don't know where to start? No worries! That's why we built the Wizard. It's a self-guided video course which helps you create your documentation yourself. No prior knowledge required. You should check it out.

Or, if you're looking for the most awesome (in our opinion) eQMS software to manage your documentation, look no further. We've built Formwork, and it even has a free version!

If you're looking for human help, did you know that we also provide some limited consulting? It's limited because we are not many people. We guide startups from start to finish in their medical device compliance.

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Sören Hornof

Hi! I am a Pharmacist with great enthusiasm for technology and innovation. Health has always been my major passion and I strongly believe that medical devices will change the world of care. Therefore, I am very happy to be able to work with progressive startups and contribute to this development.


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