The global COVID 19 outbreak and the rapid spread of the virus across the EU has led to an exponential increase in the demand for personal protective equipment (PPE, Regulation (EU) 2016/425), such as face masks and protective suits, and for medical devices (Directive 93/42/EEC resp. Regulation (EU) 2017/745) such as surgical masks and examination gloves.
In order to address the possible shortage of the above-mentioned products for healthcare professionals, the Commission recommends (Recommendation (EU) 2020/403) a series of measures to make products that do not meet the relevant formal requirements but still provide an adequate level of protection available on the European market in a timely manner. In particular, the Commission recommends the following with regard to the conformity assessment procedures to be carried out and the notified bodies entrusted with them:
- Notified bodies should prioritize and swiftly conduct the conformity assessment of PPE products.
- The WHO recommendation on the appropriate selection of PPE may be used as a potential source of reference for PPE not manufactured in accordance with harmonized standards, provided that an adequate level of protection is ensured.
- Accepted technical solutions which do not comply with harmonized standards but provide an adequate level of protection should immediately be shared by the relevant notified body with other notified bodies in the EU.
- Member States should consider exemptions from the conformity assessment procedures for medical devices.
The Commission further recommends the following for market surveillance authorities:
- (Formally) non-compliant PPE or medical devices which nevertheless provide an adequate level of protection or fulfil their intended purpose should be allowed on the market for a certain period of time
- The above-mentioned products should be taken into account accordingly in administrative procurement procedures
- The competent authorities should inform the Commission and other Member States through the ICSMS system of the authorization to make such products temporarily available
Practical advice
In particular, economic operators who manufacture and/or distribute products which provide an adequate level of health and safety protection but currently offer them for a different use or exclusively outside the EU and therefore have not (yet) undergone the relevant conformity assessment procedures can and should benefit from the recommendations.
Economic operators should proactively approach the competent authorities or bodies and have them check whether their products are covered by the above Recommendation. There is no doubt that the demand for the above-mentioned products has increased. However, the Recommendation explicitly refers to formally non-compliant products and not to products which are materially non-compliant and therefore unsafe. In the current situation, the latter would create an additional and avoidable risk for health care professionals, which must be avoided.
Finally, it should be noted that the EU Commission has made a number of harmonized standards for PPE and medical devices freely available. The harmonized standards can be downloaded free of charge from the websites of the national standards organizations.
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