Yuri Ceragioli -

The European regulation 2017/745, that will become effective in May 2020, introduces several new requirements with an impact on several aspects of the medical device field, including the classification criteria. Although the classification into risk classes (class I, class IIa, class IIb and III) has remained unchanged, new classification rules have been introduced and others have been further detailed.

This is also reflected by the the number of classification criteria that increased to 22 classification rules foreseen by the new regulation.

Therefore, specific criteria were introduced as concern software (Rule 11), nanomaterials (Rule 19), medical devices intended to administer medicinal products (Rule 20) and active therapeutic medical devices (Rule 22).

Rule 21 is of great impact for substances-based devices. In fact, according to rule 21, medical devices that are composed of substances, intended to be introduced into the human body or applied to the skin and  absorbed by or locally dispersed in the human body, will be classified as class IIa devices or higher risk class (class IIb or class III), depending on the intended use of the device itself.

Therefore, many medical devices based on substances will be subject to reclassification and this will be of great interest especially for those medical devices based on substances that were classified as class I; indeed the CE marking of a class I medical device is self-certified by the manufacturer, whereas in case of classes IIa, IIb and III the CE mark procedure requires the assessment of a notified body.

In conclusion, manufacturers should perform an assessment of the classification of their devices, in order to avoid critical issues, to adopt any possible action and to be prepared for the new requirements.


Regulatory Pharma Net is at your disposal to offer companies support for the assessment on the classification of your devices, as well as, to provide additional information and advice on quality and regulatory aspects to be compliant to the new Regulation 2017/745.

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