PXL/HO/Cir-084/2021-22                                                                                      Date: 01.10.2021

Hyderabad

Dear Sir/Madam, 

Subject: Commission Recommendation (EU) 2021/1433 on conformity assessment and market surveillance within the context of the Covid-19

We are pleased to share the latest European Commission guidelines on conformity assessment and market surveillance within the context of the Covid-19 threat  (Commission Recommendation (EU) 2021/1433 dt:1st Sep 2021) that we have received from the Embassy of India to the EU, Belgium and Luxembourg. Commission Recommendation (EU) 2021/1433 relates to procedures for placing in the EU market of personal protective equipment (PPE)/Medical Devices.

This Recommendation (2021/1433) relates specifically to the EU Commission Recommendation (EU) 2020/403 for PPE, which was issued on 13 March 2020 to provide a temporary easement process for the CE certification of personal protective equipment (PPE) /Medical devices to be used in healthcare to fight Covid-19.

This latest Recommendation (2021/1433), in essence brings about an end to this easement (according to the below timelines) and reiterates that all PPE placed on the European market after these dates must obtain full certification to the PPE Regulation.

i) Recommendations add that from 1 October 2021, all PPE placed onto the EU market must be certified fully to the PPE Regulation 2016/425. PPE placed on the market using the 2020/403 easement cannot be placed onto the market after 1 October 2021.

ii) PPE /Medical Devices which have been granted easement based on recommendation 2020/403 made in March 2020 can only be made available until 31 May 2022. The only situation where PPE using the 2020/403 easement can continue to be used after 31 May 2022 is where existing stock is used by healthcare workers, first responders and other personnel involved in efforts to contain the virus.

iii) After 31 July 2022, no PPE/Medical Devices using the 2020/403 easement can be used in any circumstances

Market surveillance authorities should inform immediately the Commission and the other Member States of all cases in which they identify a non-compliant PPE product or medical device. EC further states that market surveillance authorities should take appropriate action for the above said recommendations as mentioned in(EU)2021/1433 which is attachedfor more information.

Members dealing with PPE/Medical Devices may kindly make a note of these latest guidelines and comply with EU regulations. 

Warm Regards

Udaya Bhaskar

Director General

Encl: Commission Recommendation (EU) 2021/1433 Dt:1st Sep 2021