What is the Medical Device Regulation?

The origins of the Medical Device Regulation lie in 2005, when a manufacturer of silicone breast implants started to use a self-made formula of silicone. This resulted in leaking implants that remained on the market, and a series of incidents that occurred over more than ten years before actions were taken to solve the issue. This led the European Union to rethink their legislation, to ensure patient safety in the continent.

The Medical Device Regulation was officially announced in 2017 and kicked off in 2021. We are currently in a transitional phase, which means that companies have the time to adjust their certifications. Depending on the different types of products, deadlines for completion lie between 2026 and 2028.

The Medical Device Regulation’s goal is improving the safety of people who come into contact with medical devices. To realize this, the European Union focuses on:

• Clear documentation and risk analysis for all medical devices, provided by the manufacturer
• Stronger feedback loops from customers to the manufacturers of the products that they use
• Improved tracking of products through the EUDAMED medical products database

The Medical Device Regulation defines a medical device as any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for medical purposes. This includes devices that are used for diagnosis, prognosis, and treatment of people.

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 Medical Device Regulation.

• Some examples of Class I devices: stethoscope, hospital bed, scalpels, wheelchairs, glasses
• Some examples of Class IIa devices: external hearing aids, surgical gloves, dental filling material, needles or syringes, fridges for storing blood or tissue
• 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

The full responsibility for MDR compliance of products lies with the organizations that manufacture them.

Intended use

Each product that a company creates should have an ‘intended use’ document or statement, that describes for which purposes the company intends it to be used.

MDR rules

The MDR lists 22 ‘rules’ that detail which characteristics of a medical device define the class it should belong in. Based on the intended use and other product documentation, the manufacturer can use these rules to determine the right class for their devices.

Self-certification vs. registration through a notified body

If the intended use and product documentation align with the characteristics of a Class I medical device, the manufacturer can certify the product themselves.

For products that should belong to a higher class (and thus poses higher risk to patients), a notified body must be involved. A notified body is an organization authorized to officially assess the conformity of products, before they are placed on the market.