BMTA Newsletter BMTA Newsletter - Summer 2020 | Page 12 BSI AND PPE IN THE FIGHT AGAINST COVID-19 Nathan Shipley PPE Group Certification Manager at BSI explores how the business improvement company has been on the frontline with PPE during the COVID-19 pandemic. Personal protective equipment (PPE) has been a hot topic during the COVID-19 pandemic. Not only with frontline healthcare specialists, but also with professionals in the testing industry who have been working tirelessly to enable certified PPE to be placed on the market. CE Marking If PPE bears the CE marking, it has been assessed against the essential safety performance criteria as specified in the EU Regulation. This mark also acts as the manufacturer’s confirmation that the product adheres to the specific requirements of all the Directives that apply to it and that it can be sold legally in the EU. Previously the PPE Directive focused only on manufacturers placing products onto the market, but the PPE Regulation means the whole supply chain is involved. This means importers, distributors or anyone involved in the supply and distribution chain should take appropriate measures to ensure that PPE meets standard requirements. They should also ensure they only make products available on the market which comply with the Regulation and keep relevant documents for at least 10 years. BSI’s status as a notified body for many European Directives and Regulations enables it to offer third party testing and factory production control assessments, where products require it, and can offer support for PPE manufacturers wishing to CE mark their products. The level of involvement of BSI is determined by the Category the product falls under in the Regulation. The European Commission recommendation When the European Commission issued recommendation 2020/403 to increase the amount of PPE that could be used by healthcare professionals in the fight against COVID-19, notified bodies were encouraged to process applications for CE marking swiftly and to consider non-harmonised standards for certification. This was to enable more product to be placed on the market in the EU more quickly. Harmonised standards are listed in the Official Journal which is held on the European Commission website and is a ‘live document’ therefore updated on a regular basis. A harmonised standard is a European standard developed by a recognised European Standards Organisation: CEN, CENELEC or ETSI, created following a request from the European Commission. Nonharmonised standards comply with directives, but non-harmonised standards do not automatically comply with the essential requirements of the directives. BSI’s response In response to the European Commission’s request and in association with CEN, the European Committee for Standardisation, and CENELEC, the European Committee for Electrotechnical Standardisation, BSI has made a series of European Standards (ENs) for Personal Protective Equipment (PPE) used in the context of COVID-19 available free of charge on its website. This is to help support the efforts to fight the pandemic. BSI has also produced a number of technical specifications to fast track the certification of PPE used by healthcare workers to enable it to get to those workers who need it most. Additionally, BSI has created a guide aimed at organisations that do not normally manufacture PPE, so they can be clear of the obligations and how to ensure that the PPE is made safe to use. The standards, which cover face masks, medical gloves, protective clothing and eye masks can be accessed here. Conformity assessments and market surveillance BSI is also supporting manufacturers with conformity assessments and market surveillance procedures within the context of COVID-19 with experts available to discuss the options for clients and other manufacturers. This is to ensure compliant products can be placed on the market as quickly as possible, so that medical professionals and first responders have access to the equipment they urgently need.