noun_PPE_3462659COVID–19 Conformity Assessment and Market Surveillance procedures for PPE

Notice to applicants under Commission Recommendation (EU) 2020/403 

The EU Commission Recommendation published a decision on conformity assessment and market surveillance procedures within the context of the COVID-19 threat:

“ As from 1 October 2021, PPE which have not successfully undergone the relevant conformity assessment procedures in accordance with Article 19 of Regulation (EU) 2016/425, will no longer be authorised in accordance with the mechanisms described in points 7 or 8 of Commission Recommendation (EU) 2020/403 and cannot be placed on the Union market after 1 October 2021.

PPE, which have been granted an authorisation in accordance with the mechanisms described in point 7 or 8 of Commission Recommendation (EU) 2020/403, shall only be made available until 31 May 2022. By means of exception, any such PPE, which is part of existing stocks at the disposal of healthcare workers, first responders and other personnel involved in the efforts to contain the virus and avoid its further spread may be made available until such stocks are fully exhausted but in any event no later than 31 July 2022.”

Commission Recommendation (EU) 2021/1433 is available here.

Further Information are provided at the links below: