02.06.2022 /Trainings /ivdr

Medical devices market after May 26

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Medical devices market after May 26

May 26 will go down in history in many ways. First of all, it is worth mentioning that on this day the Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices began to apply, thus the last directive on medical devices that has been in use so far as 98/79 / EC, it loses its validity and goes down in history. It shared the fate of the previous two concerning medical devices, i.e. 90/385 / EEC, 93/42 / EEC, replaced by Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices. For manufacturers of IVD medical devices from around the world, a transitional period has begun, in which the certificates issued before May 26, 2022 are still valid, but new ones can only be issued for compliance with Regulation 2017/746. Unfortunately, so far there are only 5 notified bodies that can assess compliance in this area. CeCert, due to its undeniable competences confirmed by the notification to Directive 98/79 / EC and accreditation for the ISO 13485 program, will apply for notification in this area.

May 26 is an equally important date for domestic manufacturers of medical devices. From that day, a new act on medical devices came into force, which revolutionized the lives of manufacturers in some matters. In addition to detailing the nomenclature, terminology and liability issues, a large regulatory package regarding advertising and administrative sanctions has been added. These provisions, although in many places, give rise to certain ambiguities, which will probably be partially dispelled with time. So far, there has been a waiting period for actions by the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. How does the Office intend to use its powers, what will the penalties be? We’ll find out in the near future.

The truth is, however, that the importance of ISO 13485 certificates is increasing, especially for manufacturers of class I products. This will be the only confirmation by an independent entity of the correctness of the applied system solutions and compliance with the law. Therefore, we encourage you to familiarize yourself with our offer, both ISO 13485 certification and training, including the new act on medical devices.

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