On 5 April 2017, the European Parliament adopted two new regulations on medical devices and in vitro diagnostic medical devices. They will improve safety and make it easier to identify products.

The final vote in the EP ended the process of adopting changes to the rules on medical devices since 2012. Previous regulations date back to the 1990s and failed the time test, as symboled by the PIP breast implant scandal. Changes have therefore become necessary to prevent similar situations in the future.

The most important of the adopted changes are:

  • Obligation on notified bodies to carry out unannounced inspections at product manufacturers during the post-market period.
  • Enhance the supervision of national authorities over notified bodies. This is to harmonise the procedure for evaluating the product so that there is no so-called "safety net". 'purchases among notified bodies'. This phenomenon consists in the selection of a notified body in the country with the least strict regulations on the certification of a medical device. This was conducive to the undervaluation of standards, because after obtaining such a certificate in a state with liberal regulations, the product could already circulate on the markets of all Member States. Regulations are intended to combat this phenomenon.
  • New ways to track and identify products. The regulations introduce a system of unique identification numbers for each medical device. This will provide better handling of reports of serious product incidents and a faster response to safety issues. In addition, an "implant card" is also introduced to help doctors and patients identify what specific implant has been implanted.
  • Tightening of the criteria for the admission of products to the market. For high-risk devices, in addition to verification of compliance by notified bodies, verification by a special committee of experts shall be made in addition to verification.
  • Obligation for Member States to inform patients about the consequences of DNA testing. DNA tests can have undesirable effects on human health and life and should not be carried out without proper consultation and informing the patient of their effects.

The legislation adopted by Parliament will soon be published in the Official Journal. From the moment of publication, the provisions will necessarily take effect after 3 years – with regard to the Medical Devices Regulation and after 5 years with regard to the Regulation on in vitro diagnostic medical devices . Therefore, by 2020 and 2022 respectively, manufacturers and authorities have time to adapt to the new rules.

The texts of the Regulations are available at the following addresses:

Author: Marcin Rytel – KONDRAT Law Firm and Partners

photo source: