27.03.2020
Supply shortages of personal protective equipment (PPE) and certain medical devices have led the EU Commission to recommend exemptions from the requirements for conformity assessment and market surveillance (Commission Recommendation (EU) 2020/403).
The products concerned include face masks, protective coveralls, eyewear protection, surgical masks, exploration gloves and some gowns.
These recommendations are also particularly important for manufacturers who have not previously been active in the health sector, but who are now starting to manufacture such products in view of supply bottlenecks.
In the final analysis, the EU Commission provides for exemptions for PPE and medical devices that do not fully comply with the respective conformity assessment procedures and that provide an adequate level of protection of the users’ health and safety.
Existing manufacturers with new products but also manufacturers who are considering manufacturing the above-mentioned products in the context of the current health crisis should be aware of and follow this recommendation.
In addition, it should be noted that as of this week, the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC) are making a number of European standards for medical devices and personal protective equipment available free of charge to enable companies newly entering the market to start production quickly.
Our advice: We have up-to-date information as well as guidelines available for you on our focus page on the Corona/COVID-19 pandemic and are happy to answer any questions you may have
Cornelia Yzer
Of Counsel
Berlin
cornelia.yzer@luther-lawfirm.com
+49 30 52133 21175