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Medical devices regulation MDR comes into force

On May 26, 2021, Regulation (EU) 2017/745 on medical devices entered into force in the European Union. Adopted in April 2017, it changes the European legal framework for medical devices and introduces new primary and secondary responsibilities for the EMA and national competent authorities in the assessment of certain product categories, as well as in post-marketing safety surveillance. The decree entered into force in May 2017 and provided for a phased transition period.

However, the previously issued certificates of conformity with the requirements of the EU Council Directive of June 14, 1993, No. 93/42 / EEC on medical devices will continue to be valid until May 26, 2024.

The regulation introduces new or revised obligations of the European Medicines Agency (EMA) in relation to:

  • medicaments with a built-in device, such as pre-filled syringes and pens, and pre-filled inhalers;
  • medical devices containing ancillary drugs to ensure their correct function (eg drug-eluting stents, antibiotic-containing bone cement, catheters coated with heparin or an antibiotic agent, spermicide-coated condoms);
  • medical devices made from substances that are assimilated by the body to fulfill their purpose;
  • border products for which there is uncertainty about the appropriate regulatory framework. Certain boundaries run between medicines, medical devices, cosmetics, biocidal products, herbal medicines, and dietary supplements.

An updated guide to quality requirements for medical devices and medicines for people that include a medical device, as well as questions and answers on this topic, will be published shortly, the EMA noted.

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