Medical devices are products or equipment which are intended to be used (alone or in combination) for a medical purpose, for example, syringes, catheters, defibrillators, patient monitors or pumps (eg. insuline).
EU legislation states the products which are intended for the cleaning, disinfection or sterilisation of such medical devices fall under the same legislation, the EU Medical Devices Regulation. The goal of this Regulation is to create a harmonised market, that will ensure the availability of safe devices and fast market access, combined with balanced monitoring before and after product launch.
Relevance for the professional cleaning products industry
The new Regulation came into force in 2021 and is of interest to the detergents sector, as it covers cleaning and hygiene products specifically intended to be used on medical devices. Devices which fulfill both a medical and a non-medical purpose must comply with both the Medical Devices Regulation, as well as other applicable legislation. This can be the case for a cleaning product, which can be classed as both a detergent and a medical device, having to comply therefore with both the Detergent Regulation and the Medical Devices Regulation in this instance.
How medical devices are regulated in the EU
In the EU, medical devices must undergo a conformity assessment to demonstrate they meet legal requirements to ensure they are safe and perform as intended. They are regulated at EU Member State level, but the European Medicines Agency (EMA) is involved in the regulatory process. Manufacturers can place a CE mark of European conformity on a medical device once it has passed a conformity assessment. The conformity assessment usually involves an audit of the manufacturer’s quality system and, depending on the type of device, a review of technical documentation from the manufacturer on the safety and performance of the device.
EU Member States designate accredited notified bodies to conduct conformity assessments. For certain high-risk devices, notified bodies shall request the opinion of specific expert panels before issuing the certificate of conformity. These expert panels benefit from EMA’s technical and scientific support.
Medical devices are grouped according to risk from Class I (low risk) to Class III (high risk) according to parameters such as invasiveness and duration of use. Detergents and disinfectants used on medical devices are generally Class I and II, and each product carries a unique device identifier. A European database on medical devices and in vitro diagnostic medical devices exists called EUDAMED. Its aim is to provide a living picture of the lifecycle of the medical devices available on EU market and increase transparency. The use of EUDAMED is not yet mandatory nor required – some modules are already available and can be used voluntarily, and once EUDAMED becomes fully functional, it’s use will become mandatory.
Industry guidance
A.I.S.E. has published guidelines and guidance specifically targeted to industrial and institutional cleaning and disinfectant products in collaboration with its German national association dedicated to the professional cleaning sector, IHO. The guidelines serve as an industry-specific summary of the regulation, and as an aid in compliance, especially in borderline cases where a product is both a detergent and a medical device for example. It is relevant to companies producing and supplying cleaning and/or disinfectant products to be used on medical devices. The guidance is specifically targeted to industrial and institutional cleaning and disinfectant products. A.I.S.E. is an accredited stakeholder in the EU’s Medical Devices Coordination Group
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