An extra year to bring your medical devices into compliance
Because of the Covid-19 pandemic, the demand in medical devices keeps on increasing, as it does for hand sanitizers. This affects of course, surgical masks, but also closed suction systems, or even syringe pumps.
To counteract a potential European shortage and allow companies to make these medical devices available, the European Commission thus voted a text amending the medical devices regulation and postponing the implementation deadline of the latter. Companies may now continue to make their products compliant without fearing delays due to the overload and limited capacities of authorities and notified bodies.
The implementation of the medical devices regulation will take place on 26th May 2021, exactly a year after the initially scheduled date. The repeal of the directive on medical devices is also postponed.
This text also allows the European Commission to extend at a European level a derogation granted by a Member State regarding a specific medical device in the case where its CE marking is not yet completed and if it presents a major interest for public health.
The medical devices regulation
The regulation on medical devices came into force in 2017 and harmonises the legislation regarding the commercialisation of medical devices (MDs) at a European level. Until then, MDs were regulated by European directives. These directives allow for a freedom of interpretation by Member States since they are not directly applicable. The regulation, conversely, is applied without having to be transposed into national law. This allows for a better uniformity of the legislation and thus for increased consumer safety.
It also brings some changes: a larger application scope, new classification rules, and a better surveillance after commercialisation.
Wish to know more about your medical devices' compliance?
For more information, do not hesitate to contact Cornélia Garaudel or one of our experts via our contact form, indicating the purpose of your inquiry.
