Medical Device Regulation (MDR)

Regulation (EU) 2017/745 on medical devices becomes applicable in the European Union today, 26 May 2021.

The Medical Device Regulation (MDR), which was adopted in April 2017, changes the European legal framework for medical devices and introduces new principal and supportive responsibilities for EMA and for national competent authorities in the assessment of certain categories of products. The Regulation entered into force in May 2017 and had a staggered transitional period.

The MDR introduces new or revised responsibilities for EMA for:

• medicines with an integral device, such as pre-filled syringes and pens, and pre-filled inhalers;
• medical devices containing an ancillary medicinal substance to support the proper functioning of the device. Examples include drug-eluting stents, bone cement containing an antibiotic, catheters coated with heparin or an antibiotic agent and condoms coated with spermicides;
• medical devices made from substances that are absorbed by the human body to achieve their intended purpose;
• borderline products for which there is uncertainty over which regulatory framework applies. Common borderlines are between medicinal products, medical devices, cosmetics, biocidal products, herbal medicines and food supplements.

Medical devices are products or equipment intended for a medical purpose. In the European Union (EU) they must undergo a conformity assessment to demonstrate they meet legal requirements to ensure they are safe and perform as intended. They are regulated at EU Member State level, but the European Medicines Agency (EMA) is involved in the regulatory process.

Manufacturers can place a CE mark on a medical device once it has passed a conformity assessment. The conformity assessment usually involves an audit of the manufacturer’s quality system and, depending on the type of device, a review of technical documentation from the manufacturer on the safety and performance of the device.

Before proceeding with the assessment procedure, it is important to establish whether you, the manufacturer, can assess your product by yourself or whether you have to involve a Notified Body. 

Under MDR, if the medical device is class I (low risk) then “self-certification” is permitted unless it has measuring function or is placed on the market in a sterile condition. For any other classes, class IIa or IIb (medium risk) or class III (high risk), involvement of a Notified Body is necessary.

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