EU Medical Device Regulation Comes into Application

On 26 May 2021 the EMA announced that the Regulation (EU) 2017/745 on medical devices became applicable in the EU.

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.

The Medical Devices Regulation (Regulation (EU) 2017/745) applies from 26 May 2021, following a four-year transition period. This means that manufacturers must comply with the Regulation when placing new medical devices on the market from 26 May 2021. The Regulation repeals Directive 93/42/EEC on medical devices and the Directive 90/385/EEC on active implantable medical devices.

EMA will publish updated guidance reflecting the applicability of the Medical Devices Regulation as soon as possible.

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