Under Directives 90/385/EEC, 93/42/EEC and 98/79/EC and Regulations (EU) 2017/745 and 2017/746

1.Can a medical device be subject to regulations other than those for medical devices?

In addition to the European regulation applicable to the medical device, other regulations may also apply. For example, the Directive on electromagnetic compatibility covers the electromagnetic interference that a medical device may emit or receive.

Similarly, medical devices intended to administer a medicinal substance must also be assessed with regard to the provisions of the Directives covering the medicinal product.

2.Are the rules for placing a medical device on the market identical in all European countries?

Yes. The objective of the European regulations is to guarantee the proper functioning of the European internal market by harmonizing the provisions for placing medical devices on the market in the European Union, which can then benefit from the principle of free circulation of products.

3.Is CE marking valid for the world market?

No, the CE mark is only required on the European market. It is valid in all countries of the European Economic Area. However, the CE marking can in some cases facilitate access or regulatory procedures for other countries.

For example, the CE marking obtained under a directive is recognized in countries such as Turkey, Egypt, Morocco and Australia).

If you wish to know if a destination outside Europe recognizes the CE marking you have obtained according to a medical directive or a European regulation, you can contact the authorities of the countries concerned.

4.Where can I find the MEDDEV guides?

The MDCG guides related to the Regulations (EU) 2017/745 and (EU) 2017/746 and the MEDDEV guides related to the 3 medical directives 90/385/EEC, 93/42/EEC and 98/79/EC are available in English language on the European Commission website.

5.How do I choose a subcontractor that meets the requirements of the directives and/or regulations of medical devices?

Regardless of the regulatory framework you apply, it is your responsibility as a manufacturer to define the selection criteria for your subcontractors. These criteria must be established with regard to the product or service proposed and you must demonstrate, as a manufacturer, that you are in control of this subcontractor. The selection and the control of the subcontractor depend on the intervention of the latter in stages related to the performance and the safety of the products.

6.Unannounced audits for manufacturers of CE-marked medical devices

General topics

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