Revolutionary medical equipment regulations from May 2020
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polski
On 26 May 2020, the provisions of the EU Medical Device Regulation (MDR) will come into force in Poland. The act is aimed primarily at increasing patient safety by intensifying control over the market of medical equipment.
Improving the safety of medical devices as a priority
The new regulations introduce more requirements for clinical trials conducted on medical equipment, impose the obligation to employ a responsible person in a manufacturing plant, post-marketing supervision (prohibition of aggressive advertising) and the obligation to report side effects.
As a result of the MDR, some medical devices will also be reclassified according to risk groups. This includes, but is not limited to, certain body surface products and computer applications. This means that manufacturers of such products will have to go through a certification procedure with the participation of a notified body, for example. MDR also introduces a new class of medical devices (Ir) – reusable surgical instruments, which must be granted a limited scope certificate before being placed on the market.
The requirements for notified bodies will also change. There will be fewer of them and they will be closely monitored, but they will have more rights. In the case of class III implantable products and active class IIb products for administering or removing drugs, it will be necessary to obtain an additional opinion of the so-called “super-unit” – a panel of experts at the European Commission.
The EU regulation also extends the rules to medical equipment used in the cosmetics industry and aesthetic medicine.
The implant affair causes increased control over medical devices
Legislative action at EU level is the result of the PIP breast implant scandal – Poly Implant Prothese. Implants made from cheap silicone, which was not permitted for use in medical devices, were more susceptible to cracking than medical silicone. Silicone gel caused inflammations and scars and probably other long-term side effects. Defective medical devices were implanted in 300,000 women worldwide.
Additional regulations on the Polish market in medical equipment
The regulations, which will come into force in May, will replace the existing EU directives on medical devices (MDD) and active implantable medical devices (AIMDD). In Poland, the new regulations will be implemented under the Act on Medical Devices, although the EU regulations are directly applicable. The Act also introduces specific regulations to the Polish medical equipment market. These include, among others, regulations concerning advertising, modelled on the Pharmaceutical Law. In order to advertise a product, it will be necessary to obtain a separate consent of the manufacturer for each advertising material. There will also be an obligation to disclose transfers of benefits to users who present opinions on medical equipment in the advertisement.
It is worth noting that the next set of similar regulations will come into force in 2022. It will concern laboratory diagnostic (in vitro) equipment.
Sell-off of medical devices until 2025
Medical equipment that is legally placed on the market before 26 May 2020 will be allowed to be sold up to a maximum of 2025. Medical entities will therefore have to implement special rules of the SIWZ (specification of essential order conditions), which will enable free competition between products remaining on the market.
It is also worth mentioning the fact that certified products (classes Im, Is, IIa and III) will be able to be manufactured and introduced in accordance with previous regulations until 2024. In class I, where there is no certification, medical devices will have to be manufactured in accordance with new rules. Products that change from I to above will not be able to benefit from this transition period. However, as it will be difficult for them to obtain certificates before May 2020, it is said that additional transitional provisions will be introduced for these products.
