In view of the fact that the supply chains for PPE (in particular face masks, gloves, protective coveralls and eyewear protection) and medical devices (in particular surgical masks, exploration gloves and some gowns) are currently under severe pressure, the Commission published a recommendation on 13 March 2020 in the Official Journal of the EU (of 16 March 2020) to make these products rapidly available to those people who currently need them most urgently. The Recommendation is aimed at healthcare professionals, first responders and others involved in efforts to contain the virus and prevent its further spread. PPE intended for protection against harmful biological agents such as viruses is listed in Annex I of Regulation (EU) 2016/425 (the PPE Regulation) as Category III, which covers only those risks that can lead to very serious consequences such as death or irreversible damage to health. As far as medical devices are concerned, non-invasive devices again fall into Class I, unless specific regulations apply.
In view of the objective of ensuring the availability of PPE and medical devices during the corona crisis, it calls firstly on economic operators throughout the supply chain, secondly on notified bodies and thirdly on market surveillance authorities to take the necessary measures to adapt the EU-wide supply of PPE and medical devices to the ever-increasing demand. Notwithstanding the efforts of the actors involved, which must be vigorously pursued, it is still necessary to ensure that the PPE and medical devices concerned continue to provide adequate protection for the health and safety of users.
The following Commission recommendations are particularly important in practical terms:
- priority to conformity assessment for PPE necessary for protection against the corona virus and rapid implementation of the conformity assessment procedure by the notified bodies
- use of WHO recommendations by notified bodies when technical solutions from harmonised standards are not applied and their use as technical reference
- in the case of medical devices, the EU Member States should consider exemptions from the conformity assessment procedures, even if no notified body needs to be involved
- market surveillance law should focus on non-compliant PPE and medical devices that pose a serious risk to the health and safety of the user
- for a limited period of time, the placing on the market of PPE and medical devices which ensure an adequate level of health and safety by complying with the relevant essential safety requirements should be accepted under market surveillance law, even if the conformity assessment procedure has not yet been fully carried out or the CE marking has not yet been affixed
- in the absence of a CE marking on the PPE or medical device, however, it must be ensured that it is supplied only to healthcare professionals
Result: The Commission Recommendation in question should, on an ad hoc basis, change the practice of conformity assessment for PPE and medical devices which are currently needed to deal with the corona crisis, firstly by ensuring that notified bodies give priority to the processing of applications submitted, and secondly by making it easier to accept technical solutions other than those based on harmonised standards. In addition, PPE and medical devices that are safe and necessary for dealing with the corona crisis may be made available on the market for a limited period, even if the relevant conformity assessment procedure, including CE marking, has not yet been completed.
Link to the document: Commission recommendation (EU) 2020/403
Do you have questions about this news or do you want to discuss the news with the author? You are welcome to contact: Dr. Carsten Schucht