COVID-19: Government Guidance update on placing new PPE on the market

Correct as of 9am, 07th May. This article is not being maintained.

The Government has recently updated guidance on placing new Personal Protective Equipment (PPE) on the market. In light of the need for rapid supply during the coronavirus (COVID-19) pandemic, the process has been fast tracked by the Office for Product Safety and Standards (OPSS) in accordance with an EU recommendation to avoid delays in supply of PPE. The updated guidance only applies to COVID-19-related PPE such as disposable face masks, gloves, and gowns (or components or connexion systems for the same). The process for non-COVID-19 PPE remains in accordance with the PPE regulations.

The update on 1 May demonstrates that safety remains central to assessment prior to placing the PPE on the market, with a relaxation of requirements on the formalisation of those safety testing and approval processes. The product must continue to meet the essential safety requirements before being placed on the market as regards the reduction or elimination of identified and foreseeable risks and communications with consumers as to their role in that risk profile.

The marking and labelling as well as the associated documentation available to demonstrate the compliance with essential safety standards are being approached in a phased way under the new provisions. In order to first place the products on the market, the following requirements are waived under the new guidance:

• the need for technical certification to demonstrate how the essential requirements are met;
• the need to have carried out a conformity assessment procedure to demonstrate that production controls will ensure that PPE complies with that technical documentation; and
• the need for the PPE to be CE marked.

That is not to say that they are not needed and are no longer a legal requirement. If the product is safety compliant, these associated provisions are not required simultaneously when they are first put on sale.

The derogation allows a manufacturer to ship their product to a customer before the CE marking process is fully complete, so long as the manufacturer has engaged a Notified Body and the Notified Body has done some initial checks on the product. The manufacturer must in addition mark the Notified Body’s number on the product. After its assessment, which will include simplified product testing, the Notified Body will consider whether the product meets the essential requirements. If the evaluation of such PPE finds that it is unsafe and poses a serious risk to the users, appropriate enforcement action will follow as provided for in the PPE enforcement regulations.

Having third party approval as to essential health and safety requirements of the PPE will assist in placing it on the market and avoiding potential liability later down the line. The manufacturer and supplier remain squarely responsible for the safety and compliance of the product, but with a shift towards the inclusion of the government bodies in the assessment and with a continuing engagement in the process.

Where demand is meaning that manufacturers and suppliers are new to the market this should provide some reassurance of a streamlined process whilst reassuring consumers. The detailed guidance is supported with correspondence to the regulators that enforce these legal requirements detailing their priorities in light of the pandemic. The reflected emphasis is on ensuring supplies of essential PPE whilst continuing with the requisite testing and compliance with essential safety standards.

The Government’s updated guidance is a welcome step for manufacturers and distributors of PPE. In addition to this recent change, the Health and Safety Executive are considering whether masks approved for markets outside the UK/EU will meet essential safety requirements. Therefore, these could be placed on the UK market before conformity assessment or CE marking is completed for a temporary period, in line with the procedure outlined above. The correspondence from the OPSS makes clear that they continue to consider what further steps can be taken to speed up supply of necessary PPE and will update policy regarding any further measures.