Draft act on medical devices – new requirements

Last week, at the session of the Sejm on November 16, the draft Act on medical devices was sent for the first reading. Legislative work was carried out for over a year, and the final results will be known soon. One of the most important changes compared to the previous version of the Act will be the introduction of a number of administrative sanctions for violating the provisions of Regulations 2017/745 and 2017/746. 20 articles of Chapter 16 of the Act from Art. 74 to Art. 104. The most severe for manufacturers of medical devices may be the first of the articles, ie 74, which penalizes those who place on the market or put into service a device that does not meet the requirements set out in Annex I to Regulation 2017/745 or 2017/746. Such entities are subject to a fine in the amount of PLN 20,000 to PLN 5,000,000. For clarification, it is worth adding that Annex I to Regulation 2017/745 itself refers to general requirements for product safety and performance and contains requirements related to the functioning of the quality management system as well as the assessment, control and minimization of risk. Therefore, manufacturers of medical devices should look for help in the standard intended for medical devices between the lines, i.e. PN-EN ISO 13485: 2016-04 in the context of a quality management system and PN-EN ISO 14971:2020-05 – application of risk management to medical devices. For failure to carry out a conformity assessment of a medical device specified in Art. 52 of Regulation 2017/745 or art. 48 of Regulation 2017/746, the manufacturer may face a fine of up to PLN 500,000. And people who used a medical device for business or professional activity, before using it, did not check whether it was, inter alia, marked with the CE mark and has an EU declaration of conformity, is subject to a fine of up to PLN 250,000.

As can be seen from the example of only one article out of the twenty indicated, after the entry into force of this draft act, the market of medical devices from the manufacturer to the user awaits a real revolution, at which the provisions of the Polish Deal seem to be a trivial matter. The proposed administrative sanctions apply to manufacturers, authorized representatives, importers, distributors, users and even notified bodies, therefore the moment of entry into force of this draft act will create new rules for the functioning of the entire market for many years.
CeCert, as a future notified body, keeps track of all legal changes relating to the medical devices market. Our standard offer includes the service of assessing the technical documentation of a medical device for compliance with regulations 2017/745 and 2017/746, which gives an answer to the question to what extent your documentation meets the requirements of the indicated regulations. We are at your disposal.

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