Pursuant to the information of the website of European Medical Agency (EMA), the Regulation EU 2017/745 on Medical Devices (MDR) which was adopted in April 2017 came into application on 26 May 2021.
The MDR changes the European legal framework for medical devices and introduces new principles and supportive responsibilities for EMA and national competent authorities in the assessment of certain categories of medical products.
The new and revised responsibilities that are contained by the new regulation are the followings:
- medicines with integral devices, for instance: pre-filed syringes and inhalers;
- ancillary medical substances to supporting the proper function of the device, including the following examples: drug-eluting stents, bone cement including an antibiotic, catheters covered with heparin or an antibiotic agent, condoms which are coated with spermicides;
- such medical devices which are made from those substances that are absorbed by the human body to achieve their intended purpose for the patients health;
- borderline products for which there is uncertain which regulatory framework can be applied. The borderline products includes the followings: medical products, medical devices, cosmetics, biocidal products, herbal medicines and food supplements.
According to EMA, the Agency has worked closely with the European Commission, the national competent authorities and the pharmaceutical and medical device companies to ensure appropriate transition to the new regulation.
The EMA will make an updated guidance on quality requirements for medical devices in human medicines and medical devices which contains an updated Q&A to support the implementation of the MDR to the new regulatory framework.
The EMA also informs the interested persons that the MDR replaces the current Directives for medical devices (93/42/EEC and 90/385/EEC). The Regulation on in vitro diagnostic medical devices will replace Directive 98/79/EC when it comes into apply on 26 May 2022.
The content of this article is derived from the EMA’s website: ema.europa.eu.