Acute shortages of personal protective equipment (PPE) in the UK have been widely reported. To meet this demand, some companies are now switching their operating capabilities to manufacture PPE for the NHS, care homes and private individuals. However, the regulatory framework applicable to PPE is complex, with reports highlighting that companies are struggling to overcome the red tape.
What remains abundantly clear is that PPE should always meet the necessary safety standards. In fact, the Government reportedly had to withhold the use of 400,000 gowns ordered from Turkey, over fears they did not meet the required safety standards. Regardless, concern remains that some PPE in circulation is substandard or subject to false certifications. Companies should therefore take care when choosing to manufacture PPE and ensure they are comfortable with the safety standards. Equally, those companies purchasing PPE should be confident that the PPE is safe and fit for purpose. This can be achieved through thorough due diligence on the seller, taking all necessary steps to ensure the PPE conforms to relevant requirements and robust warranties in the procurement agreement.
The manufacture and provision of PPE in the European Union is governed by Regulation 2016/425 (the Regulation). Whilst the UK has left the EU, this legislation continues to apply during the transition period. PPE includes "equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person's health or safety". This wide definition will cover eye protection, facemasks, gloves, gowns and other protective clothing. It will not cover equipment designed to protect individuals other than the wearer. Such equipment will be seen as medical equipment or a medical device and subject to additional regulation.
Where a product falls within the definition of PPE, the manufacturer must comply with the Regulation and the product must comply with the health and safety requirements (in Annex II) and technical documentation (in Annex III). The product must also go through conformity assessment procedures (i.e. be "CE" marked), which are dependent on the risk categorisation of the product.
The UK Government has tried to simplify this process, to cope with the COVID-19 pandemic and speed up the manufacture of PPE for NHS and other frontline staff. The main guidance is the Guidance for New High Volume Manufacturers of COVID-19 PPE and the Guidance for New Small-Scale Manufacturers of COVID-19 Personal Protective Equipment. Unfortunately, the guidance is complex, with overlapping provisions, and differs depending on whether manufacturers are making high or low volume PPE, and if the end users are private individuals or NHS and other front line workers.
Key points from the guidance include:
- Manufacturers remain liable to ensure that the PPE is effective in guarding against the risks it is designed for. Manufacturers cannot disclaim their liability for ineffective PPE.
- All PPE manufactured for the COVID-19 pandemic must meet the applicable safety standards e.g. BS/EU standards and, where made for the NHS and frontline workers, applicable technical standards. If a company cannot make the PPE to the safety levels required, its PPE should not be supplied.
- The PPE will need to be assessed as safe and subject to a conformity assessment procedure by a third party assessor, known as a "Notified Body". The conformity assessment process will involve testing of the PPE.
- PPE manufactured for the NHS and frontline staff cannot be placed on the market or sold/donated to the Government or NHS before being approved by the relevant Notified Body.
- Provided PPE is made specifically for the COVID-19 pandemic and it is not for NHS or frontline use, it does not need to have completed its conformity assessment procedure before being placed on the market. However, a manufacturer must have submitted its application with the Notified Body, begun conformity assessment procedures and received confirmation from the Notified Body that the PPE has an adequate level of health and safety, before the PPE can be placed on the market. Full conformity assessment procedures must be completed as soon as possible thereafter.
- Any PPE for the NHS or other frontline workers can only be purchased by the Government or NHS and should only be used during the COVID-19 crisis, after which it must be removed from the health system.
Businesses can offer their help to the Government with large volume PPE manufacture for the NHS and frontline staff. However, many reports have discussed that companies, who have submitted their offers to help, have faced delayed responses.
Companies selling PPE for private use should consult with their Local Authority Trading Standards department, who will have additional guidance about PPE manufacture and sale. Such companies should also be mindful of applicable advertising rules when marketing their PPE.
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