Medical devices are only one of the many product groups on which the CE mark is affixed. This designation was regulated under Union law as a benchmark for certain safety and quality standards applicable to specific products, while at the same time ensuring the establishment of uniform requirements within the Community and the free movement of the goods covered by it. The mark itself therefore constitutes information and evidence for all consumers that the product in question satisfies all the requirements and requirements laid down for it. However, the CE mark should be distinguished from quality certificates, safety certificates or proofs of origin from the European Union, as it is of much broader importance. It should be emphasised that the use of the CE mark is possible and permissible only for products falling within the scope of a specific Union directive.

In the light of the Act of 20 May 2010 on Medical Devices (Journal of Laws of 20 May 2010), the Commission has adopted a decision on the use of medical devices. U. 2010, No. 107, item. 679 as of late. as a general rule, all medical devices placed on the market and put into use must be CE marked. The exception in this respect is custom-made devices, clinical trial devices, performance assessment devices, user-made devices and a system and treatment kit juxtapped together with CE-marked medical devices and sterilised treatment systems or kits or other CE-marked other sterilised medical devices.

The product in question shall be CE marked after appropriate conformity assessment procedures have been carried out to confirm that the device complies with the essential requirements relating to it. Where the obligation to mark a product with the CE mark has also been imposed in a particular situation by separate provisions, that mark shall also be affixed after the requirements laid down in those provisions have also been met. On the other hand, where the conformity assessment of a product has been carried out with the participation of a notified body, the 4-digit identification number of that body shall also be affixed to the CE mark.

The legislation attaches great importance to the proper representation of the CE mark on medical devices. In any case, it must be atoned in such a way that it is visible, legible and indelible, in the instructions for use of the product and on the commercial packaging of the product and on:

(1) packaging ensuring the sterility of the active implantable medical device;

(2) in vitro diagnostic medical devices, if possible;

(3) a medical device or its packaging ensuring sterility, if possible.

In addition, the provisions prohibit the affixing of any mark or inscription which is intended to mislead the CE marking or the number of the notified body or which restricts the visibility or legibility of the CE mark. The exact model of the CE mark is contained in the Annex to the Regulation of the Minister of Health of 23 September 2010 on the design of the CE mark (OJ C 104, 11.12.2010, p. 1). U. 2010 No. 186 item. 1252) and its individual components must be the same height, which in principle is a minimum of 5 mm.

Each time the manufacturer of the device or its importer is responsible for the presence and appropriate representation of the CE mark.

In order to make it easier for manufacturers to comply with the essential requirements for the use of the CE mark, so-called harmonised standards are established for each product group (including medical devices), the application of which confers the privilege of presumed recognition of conformity with a specific range of essential requirements. However, the mere application of those standards is not mandatory, which means that the manufacturer may otherwise develop and prove compliance with the Directive.

The CE mark shall always be affixed to the device by its manufacturer or his authorised representative, who has subjected the device or its manufacturing process to an assessment of compliance with the essential requirements. This means that no public administration or authority of the Union is competent to a label. The relevant entity shall, under its own responsibility, issue a declaration of conformity of the product and then affix the CE mark to it, which makes such a product presumed to comply with the requirements relating to its safety and quality (in accordance with the Law of 30 August 2002 on the conformity assessment system (OJ C 104, 11.12.2002, p. 1). U. of 2004 No. 204, item. 2087 as amended)). Depending on the risks posed by the product concerned and in accordance with the regulations contained in the Directives, different conformity assessment procedures are provided for.

If, contrary to the provisions of the Act, the CE mark is abusing or not abusing the device, the President of the Office shall oblige the manufacturer or his authorized representative to remedy, within the prescribed period, the failure to comply with the provisions of the Act. In the event of failure to withdraw the infringement, the President of the Office shall decide to:

  • withdrawal of a medical device from the market,
  • withdrawal from the market and use of a medical device,
  • prohibiting or restricting the placing on the market or placing on the market of the device.

KONDRAT Law Firm and Partners


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