Yuri Ceragioli -

Currently, many over-the-counter medical devices are substances or combinations of substances.

Medical devices containing substances are the medical devices that will closely be affected by the changes of the new regulation on medical device, coming into force next May 2020.

This type of medical devices will be more strictly regulated than the current directive provisions.

Presently, according to the Medical Device Directive, the only classification rule that directly mentions substances (in this case only of animal origin) is rule 17 according to which a medical device containing an animal origin substance is classified as class III, unless the substance comes in contact only with not-injured skin (in this case the device is a class I device). Additionally, it should be noted that the Medical Device Directive does not foresee any additional technical and clinical information for substance based devices.

This approach has been completely changed by the new Medical Device Regulation.

Classification rule number 21 has been introduced specifically for medical devices containing substances. According to rule number 21 devices that are composed of substances to be introduced in the body or applied on skin and are absorbed or locally dispersed in the human body must be classified as class IIa, class IIb or class III depending on their intended use.

Rule 21 implies that as of May 26th 2020 substance-based medical devices can no longer be classified as Class I. This point has a great impact in particular on all those products containing substances that today are classified as class I; these products must be classified into a higher risk class and must be evaluated by a Notified Body.

In addition, Annex II of the regulation lists the additional information that must be provided in the technical documentation for substance-based products. A challenging requirement is the additional data that must be provided concerning absorption, distribution, metabolism, toxicology and excretion.

For manufacturers of substance-based devices, meeting these new requirements might be a great challenge: stronger clinical evidence to support the safety and performance, new classification rules, the needs of be evaluated by a Notified Body and manage a CE certificate. It might also lead to additional resources being required and significant investments in pre-clinical testing and clinical investigations, to keep these products on the market under the new legislation.

The date of application of the new requirements is approaching rapidly and it is time to take decisions and act in order to be in compliance with the new regulation.

Regulatory Pharma Net is at your disposal to offer you support to better manage the transition from the current directive to the new regulation.


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