Directive 93/42/EEC

CE mark to every medical device

Since June 14, 1998, it has been mandatory to affix the CE mark to every medical device. This requires a conformity assessment procedure in which the conformity of the product with the essential requirements of the Directive is checked. Depending on the classification of the product, one of the prescribed procedures must be followed. In this context, it is irrelevant whether the device is manufactured in the EU or imported from countries outside the EU. The involvement of Notified Bodies is foreseen for all medical devices, except class I devices (without measuring function or sterile devices).
Datový zdroj 1


The EU Directive 93/42/EEC applies to the marketing and commissioning of medical devices and their accessories. The placing on the market may not be impeded by any other member state of the EU if the products bear the CE marking indicating that they comply with the essential requirements according to Art. 3 of the Directive and have been subjected to a conformity assessment. If this is not the case, then placing on the market can be prohibited.

The scope of the Directive covers all instruments, apparatus, appliances, equipment, substances or other articles, whether used alone or in combination, intended by the manufacturer to be used by humans for the following purposes:

he detection, prevention, monitoring, treatment or alleviation of disease the detection, monitoring, treatment, mitigation or compensation of injury or disability; examination, replacement or modification of the anatomical structure or a physiological process;

Conception control

and whose principal intended action in or on the human body is not obtained by pharmacological, immunological or metabolic means, but whose mode of action may be assisted by such means. The software used for the proper functioning of the medical device is also included.

The EU Medical Device Regulations (EU MDR 2017/745)

The introduction of the new MDR is a big leap for medical device manufacturing for Europe. With about six months to get their ducks in a row, manufacturers need to have a firm understanding of the new regulations and what processes they need to implement to ensure their products comply. While introducing the new requirements is undoubtedly causing headaches for manufacturers, particularly as there has been very few guidance documents released by the European Commission, the long-term benefits to patient safety make the MDR a welcome development. 

In November 2019, the European union has published a second corrigendum for the MDR, in which they have extended certain Class I devices an additional four years to comply to the MDR. This corrigendum proposes to make changes to Article 78(8), Article 84, Article 88(1), Article 120 (3), Article 120(4), Article 120(8), Article 122, Annex I and Annex III 11. However, this corrigendum needs to be adopted by the European parliament to take effect.