Regulation 2017/745 (MDR) – getting closer

Dear Sir or Madam,

May 26 this year. for all manufacturers of medical devices, it will be a date that will change the perception of the functioning of the market. It is on this day that Regulation (EU) 2017/745 MDR will apply. Thus, there is little time left for the adaptation of technical documentation by medical device manufacturers to the new requirements. This term does not apply to manufacturers whose products are certified by notified bodies and those whose products are re-classified – here the transitional period has been extended. We have no doubts that the nearest future will therefore be a period of challenges for the industry. CeCert, although it is not a notified body yet – what it is currently applying for, as a certification body specializing in conformity assessment of medical devices, it offers a wide range of services related to the verification of the production process and the documentation itself. CeCert experts, depending on the adopted formula, evaluate the technical documentation of medical devices for compliance with Regulation (EU) 2017/745 or 2017/746 and the ISO 13485 standard. Therefore, we invite you to contact us and cooperate with us.

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