10 de ago de 2023

Mastering the Medical Device Regulation

INSIGHTS - RADIOLOGIA 5 minutos de leitura

The Medical Device Regulation is still being implemented in full force across the whole of Europe, replacing the Medical Device Directive. This new law governs which medical devices are allowed to be sold on the continent.

We recently organized a webinar on the MDR. Where does it originate, and what does it mean for your medical devices? Here’s a quick introduction.

Origins of the MDR: breast implant scandal

The origins of the Medical Device Regulation lie in 2010, when a manufacturer of breast implants started using a harmful formula of silicone.

What characterizes the MDR?

The Medical Device Regulation’s main goal is to increase patient safety in Europe. It achieves this through:

  • Increased evidence of compliance

The European Union expects much more solid and scientific proof that medical devices live up to the purposes they were developed for.

  • Focus on feedback loops

Manufacturers must prove that they use complaints and market information to continuously improve the safety of their products.

  • State-of-the-art lifecycle approach

Any product that is available on the market must meet the current regulations and standards, at any moment in their lifetime – so not just at the time of their initial go-to-market launch.

So how do you define a medical device?

Whether a product is a medical device or not, is defined by its intended purpose. The company that manufactured the product is responsible for the definition and classification of the medical device.

Let’s look at an example:

High impact

The impact of the MDR is big: there are currently more than 500,000 medical devices on the European market.

Different patient risk classes

Depending on the potential patient risks associated with medical devices, they must be categorized in one of four classes. The higher the class, the stricter the requirements laid out in the MDR.

  • Some examples of Class I devices: stethoscope, hospital bed, scalpels, wheelchairs, glasses
  • Some examples of Class IIa devices: surgical gloves, dental filling material, needles or syringes, fridges for storing blood or tissue, diagnostic displays
  • Some examples of Class IIb devices: refillable insulin pens, long term corrective contact lenses, dialysis equipment, condoms, diagnostic x-ray machines
  • Some examples of Class III devices: spinal needles, cardiovascular catheters, absorbable sutures, implantable cardiac pacemakers

Certification

It is the manufacturer’s responsibility to classify their products in the correct class. The MDR legislation lists a series of 22 rules to help them do this.

When manufacturing companies find that these rules define a product as Class I, then they can do the registration themselves through a self-certification process.

For any of the higher classes, an official notified body needs to assess the products and deliver the certification. These products have a higher impact on patient safety and are reviewed together with the manufacturer's Quality Management System on a regular base.