Government makes it easier for manufacturers to offer PPE on the European market

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Following a European Commission Recommendation published on 13 March 2020 (EC Recommendation), the government have taken steps to relax regulatory requirements in relation to the production of Personal Protective Equipment (PPE) during the pandemic. The changes enable manufacturers to place PPE on the market more quickly in an effort to meet the ever increasing demand for essential equipment in the fight against COVID-19 – a move no doubt welcomed by the health care industry and PPE manufacturers alike.

The changes also mean that adaptable manufacturers, who haven’t historically placed PPE on the market, now have more flexibility to diversify their product range in order to support frontline healthcare workers, whilst also protecting their own business. However, for anyone wishing to produce PPE during this period, it’s important to understand the specific regulatory requirements that must be met. Additionally, following latest requirements implemented on 26 April 2020 to protect the supply of PPE in the EU, any PPE being exported may require a manufacturer to obtain a temporary export licence.

Manufacturing PPE – product certification

The procedure for ensuring PPE complies with relevant product safety requirements is more complicated than the self-certification regime (the requirement to produce a detailed technical file before affixing a CE mark to a product) commonly used to demonstrate compliance with relevant product safety standards.

The position pre COVID-19

EU Regulation 2016/425 (EU PPE Regulation) sets out the ‘essential requirements’ that PPE manufacturers must be able to demonstrate before PPE can be placed on the European market. This was implemented in the UK by the Personal Protective Equipment (Enforcement) Regulations 2018. Although the UK left the EU on 31 January 2020, these two pieces of legislation continue to apply during the Transition Period. In the UK, the Health and Safety Executive acts as the market surveillance authority, and has a duty to enforce the EU PPE Regulation in Great Britain.

Prior to the EC Recommendation, before CE marking could be affixed to PPE within the scope of the EU PPE Regulation, manufacturers producing higher risk PPE (which would include PPE used to protect against virus particulates) required accreditation by a third party known as a Notified Body. This process involves a Notified Body undertaking ‘conformity assessment procedures’ (including sample product testing) to ensure relevant PPE complies with essential health and safety requirements set out in the EU PPE Regulation and European Standards.

The position post COVID-19

Following the EC recommendation, the UK’s Office for Product Safety & Standards (OPSS) has issued guidance which states that, for a limited time, PPE specifically necessary in the context of the COVID-19 outbreak can be placed on the market before the completion of the conformity assessment procedure provided that:

(a)   Proposed PPE meets essential health and safety requirements set out in the EU PPE Regulation; and

(b)   Conformity assessment procedures have been started via a Notified Body.

Notified Bodies have been encouraged by the OPSS to prioritise conformity assessments for new PPE products to expedite matters. Some Notified Bodies have indicated testing and certification (sufficient to place PPE on the market under the current requirements) can be completed within as little as one week. The OPSS note that manufacturers must ensure full compliance and CE marking is completed as soon as possible thereafter. All manufacturers producing new PPE in light of the Coronavirus will therefore need to make contact with a Notified Body to conduct an urgent conformity assessment before they place new PPE products on the market.

To further facilitate the production of PPE, the European Standards relevant to PPE for COVID-19 are now available free from the British Standards Institution. These should be used by manufacturers in the early stages of production to ensure compliance with the essential health and safety requirements for PPE.

Detailed guidance for businesses wishing to manufacture PPE has been produced by the Government and can be found here.

Exporting PPE outside the EU

On 26 April 2020, the UK implemented the Commission Implementing Regulation (EU) 2020/568 to ensure there is an adequate supply of vital PPE during the pandemic in the EU, European Free Trade Association member states (Iceland, Liechtenstein, Norway and Switzerland) and certain other territories. Businesses wishing to export PPE outside of these areas will temporarily require an export licence.

Guidance setting out the exporting restrictions on PPE products and the export control process now in place, including how to apply for a licence, can be found here.