The scope of application
The scope of application of the new medical device regulation is extended compared to the old directives. Indeed, non-medical devices are now covered by the Regulation and listed in Annex XVI.
In addition, the classification of your medical devices may change. The Directives listed 18 rules for 56 criteria, while the Regulation includes 22 rules and 80 criteria. This means that devices can move from one class to another, in particular from class I to II.
In addition, medical software are now, under Regulation 2017/745, considered as medical devices, whether used alone or in combination with another device.
Notified bodies
There are currently fewer Notified Bodies (NBs) under the new MD Regulation than under the old Directives. Indeed, the control of these bodies is reinforced: they are placed under European control and now meet very strict specifications. This will result in a potentially longer time to market and stricter controls by the NBs.
The roles of economic operators
Regulation 2017/745 (MDR, regulation on medical devices) specifies in detail the notion of economic operators: manufacturer, agent, importer, distributor, or company involved for example in sterilisation.
From these different roles arise many obligations. The actor with the most responsibility is, of course, the manufacturer. The latter is defined in the Regulation as "a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark”.
Evaluation, post-marketing monitoring and vigilance
Clinical evaluation and research are regulated by stricter rules under the new regulations. With a view to strengthening consumer protection, vigilance and post-marketing monitoring have also been stepped up.
Manufacturers of medical devices will be required to have post-marketing surveillance plans and to produce a Periodic Safety Update Report (PSUR).
In terms of vigilance, any serious incident concerning MDs will have to be notified to the competent authorities, as will the corrective safety measures taken in this respect.
The UDI system and EUDAMED registration
A unique identification system is in place for all medical devices (UDIs). Based on international standards, it allows for better traceability, and therefore greater security, as well as better prevention of counterfeiting.
In parallel to this identification system, a database has been set up to record all the information on MDs collected by manufacturers and notified bodies. Named EUDAMED, this database will not make all the information public: the European Commission must "ensure that health professionals and the public have an appropriate level of access" to the database.
The context of Regulation 2017/745 on MDs
Published in 2017, the new Medical Devices Regulation, or MDR, sees its first deadline of May 26, 2021 fast approaching, after having been postponed for a year due to the Covid-19 pandemic.
This regulation was adopted with several objectives in mind. The main idea was to improve the transparency, traceability and safety of medical devices in Europe. Furthermore, a regulation, unlike a directive, applies directly without transposition into the law of each Member State. This allows a better harmonisation of standards and does not leave room for individual interpretation.
EcoMundo assists you in the implementation of the compliance strategy for your MDs, from the assessment of your needs to the completion of the dossier and certification.
