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.
Recommendations regardingconformity assessment procedure
- The notified bodies under the Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment (the “PPE Regulation”) should prioritise applications for conformity assessments regarding PPE necessary for protection in the context of the COVID-19 outbreak.
- Provided that a level of protection for PPE based on the recommendations of the World Health Organisation (WHO) and adequate to meet the requirements of the PPE Regulation can be ensured, technical solutions other than the harmonised standards may be taken into account for the assessment.
- Notified bodies which issue such certificates of conformity to PPE products should immediately inform the relevant notifying authority as well as the other notified bodies of the certificates issued in order to ensure rapid exchange of information.
- With regard to medical devices not covered by the PPE Regulation (such as surgical masks, exploration gloves and certain types of gowns), the possibility for Member States to authorise derogations from conformity assessment procedures should also be considered, according to Article 11 (13) of Directive 93/42/EEC, which is still in force.
Recommendations concerning market surveillance procedures
- Market surveillance authorities may authorise the making available of PPE or medical devices for which conformity assessments have not been carried out in full conformity with the harmonised rules, for a limited period of time, and shall as a matter of priority focus on the surveillance of such products.
- Exceptions are also provided for with regard to procurement. PPE or medical devices not bearing the CE marking shall be assessed and procured provided that it is ensured that such products are only available for healthcare workers and only for the duration of the current health crisis and that they are not entering the regular distribution channels and made available to other users.
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