In today’s article, we look at the Commission’s recommendations on conformity assessment procedures for protective equipment and medical devices in the context of the coronavirus pandemic.
The EU Commission published on 16.3.2020 Recommendation No (EU) 2020/403 on conformity assessment and market surveillance procedures in relation to the threat of COVID-19 . According to this text, personal protective equipment (face masks, gloves, protective suits, eye protection) and medical devices (surgical drapes and other products) that are related to the risk of spreading COVID-19 coronavirus infection may be placed on the market even if all conformity assessment procedures have not yet been completed, and the surveillance authorities may authorise the placing on the market of such products for a limited period of time until the conformity assessment procedures have been properly completed. Supervisory authorities should focus priority on controlling products that pose a serious risk to the health and safety of users (in other words, supervisory authorities should not be so concerned with formalities for these products).
In view of the current situation of the spread of coronavirus worldwide and the need to provide PPE and medical devices to health care workers and persons in primary need, the Commission has issued this Recommendation, in which it has expressed the need to make the necessary PPE or medical devices available primarily to health care workers. It also called on states to use all measures at their disposal to ensure the supply of PPE (subject, of course, to health and safety standards).
At the same time, the Commission urges notified bodies to prioritise the conformity assessment of all newly submitted applications for the PPE in question, while allowing for derogations from harmonised standards containing technical solutions.
Of relevance in this Recommendation is Article 7, which reads as follows: “Where market surveillance authorities find that PPE or medical devices provide an adequate level of health and safety protection in accordance with the essential requirements laid down in Regulation (EU) 2016/425 or with the requirements of Directive 93/42/EEC or Regulation (EU) 2017/745, even if the conformity assessment procedures, including the affixing of the CE marking, have not been fully completed in accordance with the harmonised rules, they may authorise the making available on the Union market of these products for a limited period of time and while the necessary procedures are being carried out.”
Certain formalities are therefore allowed to be put on the back burner for the moment when placing PPE on the market, but this does not mean that there are suddenly no rules in this area. Even in this emergency situation, two requirements must be met. The first is the demonstration of a sufficient level of health and safety protection, which PPE must possess . This requirement corresponds to compliance with the requirements set out in Regulation (EU) 2016/425, Annex II. The second is the need to initiate a conformity assessment. To summarise, a product may be placed on the market if it complies with the requirements set out in Annex II of Regulation (EU) 2016/425 and the conformity assessment procedure has already been initiated for it.
Normally, personal protective equipment has to go through a long process to reach the European market. Several conditions must be met, ranging from obtaining a certificate from a testing laboratory, meeting the requirements of Regulation (EU) 2016/425, complying with EN 149+A1 (the standard setting out the minimum requirements for filtering respirators, if we focus on respirators specifically for example), marking the protection class and indicating whether the product is intended for single or repeated use, to affixing the CE conformity marking. Today’s emergency situation accelerates this process considerably. As a result, products that have not been verified or even do not meet all the required requirements may enter the market .
In the case of medical devices, the situation is in principle even simpler. Medical devices such as surgical drapes fall into risk class I, for which conformity assessment is carried out by the manufacturer in a process of so-called self-certification (i.e. without the involvement of a notified body). In simple terms, the European Commission’s intention with this Recommendation is to say that (i) if the manufacturer has sufficient documentation to demonstrate the conformity of the medical device with the essential requirements for safety and efficacy and (ii) starts work to ensure that the product undergoes conformity assessment in accordance with the relevant procedures (i.e. until 25 May 2020 in accordance with Annex 7 of Government Regulation No 54/2015 Coll.), the supervisory authorities may tolerate the placing on the market of such medical device .
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This article is for informational purposes only and does not constitute legal advice or guidance for any particular case.