How the Medical Device Regulation Impacts Consumers and Patients

The Medical Device Regulation was implemented in an attempt to increase the safety of medical devices launched in the European Union.

Medical device manufacturers making medical devices for the EU market will have to transition completely to the MDR before the end of 2024. By then, it will have replaced the Medical Device Directive in hopes to remedy alleged weaknesses found in it.

However, this transition does not come without risks and knock-on effects for patients and consumers.

Current medical devices will be removed from the market

As a result of the safety requirements and higher cost associated with showing that medical devices meet the new requirements of the Medical Device Regulation (MDR), many medical devices are at risk of being removed from the EU market by manufacturers.

This applies not only to new medical devices, but also medical devices with many years of data that demonstrate its safe use from all over the world. This translates to some severe challenges for healthcare providers in the European Union.

Many of the staple devices used in healthcare may no longer be accessible for treatment options, which will impact patient care. This is particularly relevant to medical devices that are used for small patient groups and in conjunction with rare diseases.

Many manufacturer’s representatives are shocked when they take part in an introduction to the medical device regulation and realise the time and effort it takes to learn and implement and the consequences it will have on the timelines and product mix they are offering to the market.

New medical device models will be more expensive

The MDR also has an effect on new medical devices waiting to be launched in the EU. Newer models will enter the market with a higher price tag due to an increased cost in meeting the new requirements of the Medical Device Regulation.

Why is it more expensive for manufacturers to get medical devices CE-marked?

One crucial part of putting a new medical device on the EU market is to have a notified body review the technical documentation of the medical device and the manufacturer’s quality management system.

With the MDR in place, the review time is dramatically increased, and with scarce availability of notified bodies that are allowed to issue certificates based on the MDR, qualified notified bodies can raise their fees due to increased demand.

Acquiring the necessary certification for just one product with one notified body can easily cost the manufacturer 80 000–150 000 euro.

A negative impact on innovative medical devices

The higher cost involved in getting a medical device approved by a notified body and CE-marked will have a negative effect on smaller medical device manufacturers and companies.

This in turn may lead to fewer new, innovative state-of-the-art medical products since smaller businesses simply will not have the finances to target the EU.

Longer wait time to get notified body approval

Due to fewer qualified notified bodies, the wait time to get the certification from a notified body will be longer.

Since this will greatly impact time to get the product to market and therefore also costs and income, many small and mid-sized medical device manufacturers are turning to the US market before the EU.

The result: Decreased quality of healthcare

The new changes relating to the Medical Device Regulation means that healthcare systems and clinics may experience many challenges ahead.

While these difficulties are very serious for consumers and patients, they will likely even out in the long run; the European Union is a large market in high demand for many manufacturers.

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