On 7 March 2017, the Council of the European Union adopted draft two regulations – on medical devices and in vitro diagnostic medical devices. According to a press release issued on this issue, the new rules are intended to increase safety while ensuring rapid access to innovative health solutions.
The new rules are intended as a response to new technologies and developments in the field of medical devices. One of the stimuli of the changes became the high-profile case of defective silicone breast implants used in nearly half a million women. Regular inspection of implant parts by experts is foreseen. There is also a need for EU regulation of devices that do not necessarily have a strictly medical use, such as coloured contact lenses. The new rules are intended to meet this need.
The new regulations provide that notified bodies will be given wider opportunities to assess products before placing on the market and supervise products already on the market. The powers of notified bodies will be harmonised in EU countries so that equally high safety standards in this regard apply everywhere. The rules also provide that manufacturers of devices will track the quality, functioning and safety of devices through better availability of clinical data.
The regulations also establish a central database of products available in the EU. This will give healthcare professionals and patients a better view and help them choose the right product.
The traceability of the device is to be ensured by the introduction of special unique identification numbers for medical devices. This will facilitate product tracking at each stage of the intermediary between the manufacturer and the patient and will allow for more effective prevention in the event of defects in devices, in particular those causing a safety risk.
It is estimated that the regulations are to be adopted by the European Parliament in the second quarter of this year. The new regulations on in vitro diagnostic medical devices and medical devices will take effect 3 and 5 years after publication respectively. The provisions of eu regulations apply directly. They aim to harmonise the law in a given case throughout the European Union. If there are no delays in the legislative process, the first regulation will take effect as early as 2020. Major changes in the functioning of the medical devices market are therefore to be expected.
Author: Marcin Rytel – KONDRAT Law Firm and Partners
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