New PPE Guidance from the Office for Product Safety and Standards
In March 2020 the EU Commission published their ‘recommendation’ on COVID 19 related PPE conformity assessment which was an attempt to alleviate the severe supply shortages for healthcare and key workers.
The UK adopted the ‘recommendation’ and published guidance on how to be able to place COVID 19 products on the market without completing the normal CE conformity assessment process.
The guidance is primarily for manufacturers of PPE but of course ‘Importers’ and Importers’ obligations are also laid out. These can be found in section 9 of the guidance.
The most significant change being, The new guidance still requires the submission to and confirmation of acceptance by a Notified Body of PPE for conformity assessment. However if you wish to begin selling this product prior to the completion of the full CE conformity assessment process you must get the approval from the market surveillance authority (MSA), who are responsible for confirming that it meets the necessary essential health and safety requirements. This approval must be obtained from the Health and Safety Executive (HSE) or HSENI in Northern Ireland. You can apply for this approval through emailing MarketSurvPPE@hes.gov.uk (If PPE is exclusively for private consumers use Trading Standards and the relevant MSA)
This is clearly an important requirement and a key difference from previous guidance. There are many other conditions carried over from previous versions which of course must also be adhered to.
Although this process is, by its nature temporary it has been in existence for 5 months and there will be PPE that is at various stages of the easement assessment process.