This Changes Everything: MDR and the Role of the EU Legal Representative

| by Tamsyn Frost

The medical devices industry has changed dramatically in recent years. Historically, medical devices had more in common with product manufacturing industries such as aviation, which meant testing and standards were very engineering focussed:

  • Is the product built robustly?
  • Are the materials adequate for their intended purpose?
  • Will the product and materials last?

While those standards remain important, the vast range of medical devices – from surgical gloves to MRI machines to implantable products such as heart valves and beyond – has made it necessary to adapt classifications and tighten standards and regulations. The new Medical Devices Regulation (MDR) is designed to address these massive variations in devices and the specific set of ISO standards for their design, production, installation, and servicing.

It also explains why a robust quality system and an EU legal representative who understands the complexities involved and the kinds of clinical investigations that are required are both imperative.

Responding to Life-Threatening Problems

A major reason for the European Medicines Agency updating the Medical Devices Directive to the MDR is because of serious problems that arose with PIP breast implants containing unapproved silicone gel (cheap industrial-grade, rather than medical-grade causing abnormally high rupture rates). Today, patients are still having those dangerous devices removed, and because they were not properly recorded when they were implanted, some patients don’t know whether they have a product that has been recalled or not.

These are the types of quality measures that need to be carefully monitored. In clinical investigations, if patients are being given an experimental implantable device, the study organisers need to know exactly which one it was that went into that person to be able to contact them in case there is an issue or recall, even after the official study follow up period ends. Further compounding this is the need to take GDPR protection into consideration, which can be a nightmare for non-EU based companies because personal data leaving the EU is subject to different rules under GDPR.

That means the medical device company needs a robust quality system that has enough understanding of the company’s product and the regulations that apply to it. It’s okay not to know at first, given that so much is new in the industry, but companies do need to be implementing proper QA measures.

“It’s okay to have gaps in the quality system, but you need to be aware of them and be taking appropriate steps to address them.”

Asking the right questions

As a legal representative for a device investigation, I would be asking questions that ensure the right measures are being developed. I would also want to know about training plans, how these are being documented, what system is being used to capture what is unknown and what steps are being taken to address any gaps? It’s okay to have gaps in the quality system, but you need to be aware of them and be taking appropriate steps to address them.

Another consideration for companies to deal with is changing regulations. Your legal representative should be asking whether the standard currently applicable to your company’s product is still valid in six months time or has it been updated under MDR. It’s now relatively easy to set up a system to capture changes, for example using RSS alerts, but these are all steps that need to be put in place, especially with medical devices because there are so many intricate regulations and standards depending on the product.

For example, a micro-surgical clot removing device could have four different parts to it and each part has a different standard it needs to comply with, including ensuring any part that is in contact with tissue won’t cause a reaction and has been appropriately sterilised.

Understanding the standards

There is a huge amount of information on standards on the ISO website and notified bodies will be able to help companies with many of their questions around these. But does the QA system alert you early enough to talk to a notified body? And how does a company new to the industry or the region select an appropriate notified body for their product?

IDEA Regulatory has been managing these kinds of processes for 13 years, helping clients through the EU regulatory maze to find the appropriate path for their product. These types of discussions are very much product and client-specific, depending on how the company is set up, how they are operating, and the capabilities of their in-house team. Successfully guiding companies is about building close working relationships and becoming part of the company’s family within the EU and this is what we strive for at IDEA.

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