QualityHub EU MDR Experts Answer Your Questions

Your Questions. Expert Answers.

Despite the long run up to preparations, it can still feel like you’re not prepared for EU MDR compliance. With the new MDR deadline rapidly approaching, we asked our QualityHub team to create this MDR FAQ resource.

Mark Your Calendars: The current EU MDR compliance deadline is May 26, 2021. 

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What are the regulatory requirements for the PRRC (Person Responsible for Regulatory Compliance)?

You must assign at least one person responsible for regulatory compliance. Having a PRRC is mandatory.  The expertise of the person(s) responsible for MDR compliance will have to be demonstrated. You will need to document the qualifications of this/these individual(s). The person(s) responsible for regulatory compliance cannot also be the EU authorized representative.

If a medical device conforms to the current MDD can it still be placed on the EU market, or does it need to be recertified?

According to Article 120 (2-4), an additional conditional transition period is possible, but only for devices which still have a valid (MDD) Notified Body that was certified by May of 2020. Those devices can continue to be placed on the EU market and put into service as long their certificate is valid. This additional transition period is limited: Placing on the market date for MDD certified devices ends in May 2024, putting MDD certified devices into service ends in May 2025.

There are conditions: Not only must the manufacturer have a valid MDD certificate for the device. The manufacturer must also comply with the new EU MDR requirements for post-market surveillance, vigilance and registration.

What are the biggest underestimations people are making regarding EU MDR?​

Time and resources/staffing are two of the biggest issues we’ve seen with clients regarding EU MDR preparedness. Companies often assume that EU MDR won’t differ much from current certifications, and thus, it can be pushed to a later due date or further down a priority list. There’s also a tendency to put only a handful of people on the project, especially if there’s no way to create a dedicated EU MDR task force or team.

How has the definition of “medical device” changed?

The new EU MDR definition of “medical device” expands the term and includes more devices than before. For example, the expanded definition now includes items like colored contact lenses, cosmetic devices, and devices for the purpose of “prediction and prognosis” of disease.

What’s the cost (in both time and resources) for technical documentation for EU MDR?

In short, it will vary depending on device classification. All devices need proper tech docs for EU MDR compliance, and those documents must be maintained per compliance needs. Companies should consider the respective costs with respect to sale volumes and estimated time/cost investment in maintaining the documents. Notified Bodies will treat each submission as if it’s the first time they’ve seen the documents.

What role will Notified Bodies play in post-market surveillance?

Under MDR, your Notified Bodies will have more authority in post-market surveillance. Now, Notified Bodies can have the ability to perform unannounced audits at certain checkpoints throughout the compliance process.

Do you still have questions about:

  • Transitioning to EU MDR?
  • Developing your regulatory plan?
  • Preparing for certification by a Notified Body?

Leave your questions here to reach a QualityHub EU MDR expert. 

If your team is having trouble transitioning to EU MDR, QualityHub can provide the strategy and framework for successful implementation.