Regulation 2017/745 – it has become a fact

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Regulation 2017/745 – it has become a fact

The medical devices market had to wait a long time for regulatory changes. Nearly 30 years after the entry into force of Directive 93/42 / EEC and more than 20 years after the entry into force of Directive 98/79 / EC, a “revolution” has taken place. The new requirements introduce many significant changes to the medical devices market. Greater emphasis on the functioning of the quality management system at manufacturers, new requirements for risk management, product labeling and product traceability, etc. For some manufacturers, however, the changes will take effect only in a few years. This applies in particular to product manufacturers who, in accordance with Annex VIII of Regulation 2017/745, will change the class of the products being introduced from I to, for example, IIa or higher. In addition, manufacturers whose products are already subject to the assessment process by notified bodies will be able to continue to introduce their products until the end of the validity of the current certificate, but no longer than until May 27, 2024. Thus, despite the start of the application of new regulations, the medical devices market is still in a transitional period. However, this does not change the fact that the new regulation caused a stir among manufacturers, especially with regard to the fulfillment of these requirements. Therefore, we invite you to cooperate in the area of ​​ evaluation of technical documentation of medical devices .

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