New European Union legislation brings unified regulation of the European market for medical devices
On 26 May, after a one-year delay caused by the coronavirus pandemic, regulation (EU) 745/2017, on medical devices, came into effect. The regulation replaces previous directives and brings a single comprehensive regulation of the development, manufacture and distribution of medical devices. On the same date, Act No. 89/2021 Coll. came into force, which, following Regulation (EU) 2017/745, specifies, among other things, the competence of administrative authorities, the functioning of the Medical Device Information System or the conduct of clinical investigations.
The regulation distinguishes between medical devices and in vitro medical devices (diagnostic medical devices), which are subject to Regulation (EU) 2017/746. Medical devices under Regulation (EU) 2017/745 are then defined as instruments, devices, equipment, software, implants, reagents, materials or other items intended for specific medical purposes. Furthermore, medical devices are divided into four classes according to their purpose and risks, on the basis of which different rules are then set for placing them on the market.
A new electronic system EUDAMED (European database on medical devices) is implemented and it includes several electronic systems such as the device database, the economic operators database or the clinical investigations systém.
Manufacturers not established in the European Union must have an authorised representative who carries out specific duties on their behalf and cooperates with the competent authorities. Manufacturers, authorised representatives or distributors must also register in the electronic system.
Before placing on the market, registered economic operators have to fulfil various obligations. These include, on the one hand, drawing up technical documentation and carrying out clinical investigations or clinical tests and, on the other hand, obtaining a certificate to sell the device on the EU market, which is issued by so-called notified bodies that assess the compliance of the device with the legislation in force.
After entering the market, registered economic operators must, among other things, register devices through the UDI-DI database, maintain a risk management system that documents potential risks, or have access to an electronic system on vigilance to report any adverse event to the system.
The new EU regulation of medical devices may appear to be quite complex and complicated. That’s why our law firm rutland & partners can assist you, as we have extensive experience in the field and offer comprehensive legal services to manufacturers or distributors of medical devices. So do not hesitate to contact us for more information.
Monika Rutland, partner
rutland & partners, law firm
tel: 226 226 026