In May 2017, the European Parliament published the new regulation for medical devices (MDR – Medical Device Regulation (EU) 2017/745) that will become fully applicable in May 2020.
An important consequence of the MDR is the reclassification of certain medical devices. Although the classification does not radically differ from the MDD, the MDR introduces the following 4 new classification rules:
- Rule 19 – Devices incorporating or consisting of nanomaterial
- Rule 20 – Invasive devices intended to administer medicinal products by inhalation
- Rule 21 – Devices composed of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed or locally dispersed
- Rule 22 – Active therapeutic devices with an integrated or incorporated diagnostic function that significantly determines the patient management
Medical device manufacturers should be aware of these changes since the classification of a medical device is a critical factor for determining the requirements of the conformity assessment. In particular, substance-based medical devices typically include over the counter formulations such as lozenges, skin creams, nasal sprays and cough syrups, among others.
According to the current MDD – Medical Device Directive 93/42/EC, the vast majority of them fall under the lowest risk class known as Class I. However, following the new Rule 21 of MDR, medical devices that are composed of substances or combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin will be upclassified from Class I to Class IIa, IIb or III depending on the application site and level of absorption.
As a consequence, CE marking of such devices will no longer rely on a signed Declaration of Conformity by the manufacturer, but will require undergoing a conformity evaluation procedure with a notified body.
During the conformity evaluation procedure, the notified body, beyond reviewing the technical documentation of the device and the quality management system of the manufacturer, will consult a medicinal product authority for a scientific opinion on the quality and safety of the medical device, which will be given special consideration during the certification decision. Besides, substance-based medical devices should comply, when applicable, with some requirements of Annex I of the medicinal products directive 2001/83/EC related to the evaluation of absorption, distribution, metabolism, excretion, local tolerance, toxicity, interaction with other devices, medicinal products or other substances and potential for adverse reactions.
If you need some help to confirm possible upclassifications of your substance-based medical deviceand review the compliance with the requirements of the new MDR contact us: [email protected]
Asphalion can assess you in that process!