This article was co-authored by Natalie Man, Litigation Assistant, London.
On 2 September 2021, the EU issued their second recommendation under (EU) 2021/1433 on conformity assessment and market surveillance procedures for Personal Protective Equipment (PPE) in relation to the COVID-19 pandemic and in light of the exceptional situation caused by COVID-19 and the unprecedented levels of demand for PPE in response to the pandemic.
The European Commission’s first Recommendation (EU) 2020/403 encouraged Notified Bodies to process applications for CE marking swiftly and to consider non-harmonised standards for certification. This guidance was adopted to enable more products to be placed on the market in the EU more quickly. It also aimed to reduce the risk of medical professionals and first responders, not having access to the correct or to sufficient PPE.
Considering the reduction in the supply and demand for PPE and medical devices recently, the commission has decided to discontinue the application for the above proposals under the Second Recommendation (EU) 2021/1433. This recommendation states that Member States market surveillance authorities should no longer authorise PPE or medical devices which are not in conformity with relevant EU legislation regulating these products. The main focus was face masks, but also gloves, protective coveralls and eyewear protection. Although there will be an adjustment period for operators, from 1 October 2021, market surveillance authorities should no longer authorise PPE which have not gone through the relevant conformity assessment procedures in accordance with Article 19 of Regulation (EU) 2016/425.
This latest recommendation (2021/1433) reiterates that manufacturers or distributors must act to ensure all PPE placed on the EU market obtain full certification to the PPE regulation. Manufacturers and operators should be aware of the above changes to prevent applications being made which are no longer relevant and should consider the consequences of any recent applications that have been swiftly processed for the purposes of the pandemic but pose risks as a result of not undergoing the correct process for certification.
This change in position serves to reminder all those involved in this industry that the unprecedented derogations and temporary suspension of usual regulatory processes granted by regulators during the pandemic can and will come to an end, and long-term planning strategy for product production should be premised on this. Product safety and product liability exposure is also dependent on this changing regulatory landscape.
- Ensure manufacturers or distributors understand the changes, following the recent implementation and changes to conformity of PPE and act to ensure they are following the correct legislation.
- Focus on non-compliant PPE or medical devices posing serious risks as to the health and safety of their users.
- Any PPE already placed on the market using the 2020/403 easement can only be made available until 31 May 2022.
- Ensure all PPE or medical devices have successfully passed the relevant conformity assessment procedures in accordance with Regulation 2016/245.
- From 1 October 2021 all PPE placed onto the EU must conform to the PPE Regulation 2016/245.