Substance-based medical devices, refer to products that are composed of substances or of combinations of substances that are absorbed by or locally dispersed in the human body and that are intended by the manufacturer to be introduced into the human body via a body orifice or applied to the skin. According to the classification rules of Directive 93/42/EEC (MDD), the manufacturer placed them on the market as Class I medical devices.
The impact of the Medical Device Regulation EU 2017/745 (MDR), becoming applicable on May 2021, is significant and challenges the manufacturers of substance-based devices. Substances-based Medical devices must meet stricter requirements. A new classification rule (rule 21) is introduced for medical devices, that are composed of substances, with Class IIa as a default risk class. As a consequence, these devices will be classified in higher risk classes.
This means that, from next May 26th, 2021, substance-based medical devices can no longer be classified as Class I. Wetting agents, nasal and throat sprays or ear drops currently on the market as devices Class I will now face a procedure for assessing the compliance and the participation of a notified body in order to audit aspects related to the product and the manufacturer’s quality management system. Even invasive devices currently classified as Class IIa will increase their class of risks and will be classified according to Class IIb (for example, vaginal gels).
Many manufacturers may think that, since the MDR states that products with CE marking under the MDD can still be marketed up to four years after the date of application of the MDR, that is, until 2024, they still have time to adapt their dossiers and undergo an evaluation procedure by a notified body. However, this is valid for those devices that will not incur in any change during this period. For all the other cases, they will have to be in compliance with the MDR starting from May 26th, 2021 and cannot be Class I anymore.
For manufacturers of substance-based devices, meeting these new requirements adds to the efforts needed to provide stronger clinical evidence to support the safety and performance of their devices. As the MDR application date is fast approaching, particularly for manufacturers of Class I products that cannot be marketed after May 26th 2021, it is time to make fast decisions.
The aim of this webinar is to provide useful insights to manufacturers on how to keep these products in the market according to the new legislation, how to adapt the technical dossiers of the products to the requirements of the MDR, how to carry out the preclinical tests and necessary clinical investigations, as well as guiding the manufacturer in the implementation of a quality management system according to ISO 13458.