On 26 May 2021, Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on Medical Devices (MDR) came into force, and this means revolutionary changes in many areas of the medical devices industry. The regulation changes current regulations concerning clinical trials for the most technologically advanced products. It also introduces major amendments to rules on regulatory compliance of a device post marketing authorization and on classification of software as a medical device.
In Poland, work on the bill implementing the Regulation is still in progress. It is important to note, though, that in this current version the bill imposes significantly more obligations on MD producers, importers and distributors than the EU Regulation itself. Firstly, the proposal foresees major limitations on marketing and promotion, modelled on limitations on advertising of medicinal products. It would no longer be permitted to use the image of people practicing a medical profession or purporting to be people practicing a medical profession, or to show people presenting a device in a manner that suggests that they practice a medical profession when advertising of such a device is directed towards the general public. Also, it would not be possible for advertising to directly encourage children to purchase the devices in question or to encourage parents or other adults to buy them those devices (art. 65(2) of the bill). The proposal keeps in place a twofold notification system under which medical products have to be registered on the Polish distributor list in addition to obligatory registration in EUDAMED.
Finally, the bill provides for more than 60 rules on penalties, including stiff penalties for breaching regulatory obligations, for example:
- under article 77 – a manufacturer in breach of regulatory requirements may be fined between PLN 50 000 and PLN 5 000 000 (for example for breaching risk management regulations – up to PLN 500 000, or not complying with basic manufacturer obligations under article 10(1) of the MDR – up to PLN 5 000 000)
- under article 78 (3,4) – an importer that does not provide conditions of storage or transportation ensuring compliance of the device with general safety and operation requirements, and with the manufacturer’s requirements, while being responsible for the device, may be fined up to PLN 150 000.
The bill is available here. It was to be adopted in QI 2021, and is now undergoing public consultations. We will provide updates on the final wording of the bill in forthcoming newsletters.