Medical devices: the new European regulation
What is new?
A larger scope
With the new regulation on medical devices coming into force in the European Union, more products are now covered. Medical devices with a non-medical purpose will now fall within the scope of the regulation.
These devices, with an aesthetic purpose, are listed at Annex XVI of the regulation and could be problematic regarding borderline products (in between two regulation). These Annex XVI products can be, for instance, intense pulsed light equipment, breast prosthesis, or even contact lenses with an aesthetic purpose.
Borderline products in between other regulations also exist. For instance oral care products might be considered, depending on the product, a medical device or a cosmetic. EcoMundo will soon publish an article on medical device borderline products to make their identification easier.
New classification rules
Classification modifications are important to note. The regulation increases the number of classification rules from 18 to 22. An old directive class I device might now be considered class IIa, with this new regulation. Anticipation of the deadlines and caution are essential.
Greater surveillance
The main objective of European regulations remains protecting consumers. Here, it was more specifically harmonising the requirements in terms of device safety.
A better pre-marketing evaluation is now demanded. To achieve this, more information and data must be provided. Notified bodies of each state are now placed under European control, guaranteeing the same standard of requirement in every state.
Post-marketing safety monitoring has also been improved. Not only will companies need to make periodic reports on the device safety, but a new monitoring tool will also be implemented at a European scale.
Indeed, a European database on medical devices - EUDAMED - is currently being developed by the European Union. It should be operational before 25th March 2020. The latter will allow economic operators to register themselves and medical devices, but also to centralise clinical investigations, vigilance, market surveillance, etc. Of course, all data will not be made public. This database will work with a Unique Device Identifier (or UDI) system. The UDI will be made up of a device identifier and production unit identifier.
Deadlines and key dates
The regulation will be applied from 26th May 2020, with the repeal of the directives in their quasi-entirety, but there are also other dates to remember. Here is a quick summary:
The implementation of the regulation will stretch on several years:
- At its date of application, in May 2020, all classes of devices will need to comply with the regulation,
- Between 2022 and 2024, certificates delivered under the directives will be invalidated,
- On 27th May 2024, with the invalidation of the last certificates, all medical devices from class IIa to III will have to comply with the regulation,
- Devices legally commercialised under the directives may still be made available on the market or put into service until 27th May 2025.
EcoMundo’s experts will handle the registration of your medical devices from class I to IIa. Thanks to their in-depth knowledge of this new regulation, our specialists advise you on the strategy to follow to best anticipate the future deadlines.
Context: why this regulation?
European directives that regulated the marketing of medical devices until now dated back to 1990, for the oldest ones. As directives, they did not have direct applicability and so had to be transposed to the national legislations of each state.
Thus, each member state had the liberty to interpret the texts, creating disparities in their application.
A regulation however, has direct applicability in all member states and allows for this reason a harmonisation of the requirements regarding the marketing of medical devices.
To this we must add the different scandals that took place over the years in the medical device industry. The directives were blamed for the lack of consumer safety. The new regulation therefore addresses these shortcomings and increases the safety of the devices.
