This week, we take a closer look at issues relating to the supply and use of personal protective equipment (“PPE”) in the context of the response to the COVID-19 crisis.
The coronavirus outbreak continues to have an immense impact on the supply of PPE, with countries all over the world reporting shortages of the facemasks, gloves, surgical gowns and eyewear protection that are central to the fight against COVID-19. Manufacturers already in the PPE space have responded by expediting production and producing larger volumes of product. Manufacturers in different sectors/industries have also turned their efforts towards the production of PPE.
PPE or medical device?
The regulatory regime applicable to PPE in Europe is not straightforward, with products potentially falling within the scope of one of two complex EU product safety regimes:
- PPE legislation, which covers the design, manufacture and marketing of PPE, governed by EU Regulation 2016/425 (the “PPE Regulation”); and/or
- the medical devices legislative suite, which aims to ensure the safety and efficacy of medical devices across Europe, governed currently in principle by Council Directive 93/42/EEC concerning medical devices (the “Medical Devices Directive”, which is soon to be replaced by a new legislative regime which, because of COVID-19, has had its date of application delayed by one year until 26 May 2021).
Whilst a case-by-case analysis of any borderline products is always warranted, there are a few principles, recently reiterated in authorities’ publications on PPE production during COVID-19, that assist in distinguishing between PPE and medical devices.
- Where a product’s main purpose is to protect a patient from the user (for example, a surgical face mask), it may be regulated as a medical device. Likewise, if a medical gown is used to protect a patient from the wearer (i.e. a healthcare worker), it is a medical device.
- If the product’s main purpose is to protect the wearer, e.g. to protect the healthcare worker from the patient, it is PPE.
In the EU, protective equipment including masks, gowns, safety glasses and disposable gloves played a critical role in protecting healthcare workers in EU countries during the first months of the COVID-19 pandemic. Now, some of this equipment is also playing an increasingly important part in Member States’ plans to lift lockdown measures. In Austria, the Czech Republic, France, Germany, Luxembourg and Slovakia, for example, there are requirements for citizens to wear facemasks in public locations. Moreover, there is increasing demand for protective equipment from EU companies whose workers are returning to offices and factories. This “new normal” raises issues for businesses seeking to supply, source and provide protective equipment for healthcare workers, consumers or employees.
The PPE Regulation and Medical Devices Directive establish stringent requirements for the design, manufacture and sale of protective equipment that falls within their scope. Equipment must usually undergo a full conformity procedure to demonstrate compliance with requirements before it can be CE marked and lawfully marketed.
The European Commission has taken measures in Recommendation 2020/403 to relax these stringent requirements for equipment produced for healthcare workers during the current pandemic. Importantly, these measures include flexibility to place equipment on the EU market before it has been CE marked. This is a significant relaxation of usual hurdles, and demonstrates how seriously the EU is taking its efforts to remove barriers to getting this equipment to market. These measures sit alongside other initiatives including making technical standards available free of charge, and offering advice to companies who have not previously manufactured PPE. For more information, please see our previous blog post here.
However, manufacturers should be aware that the EU’s regulatory flexibilities are designed to apply only in limited circumstances. Notably, protective equipment must be:
- part of a purchase organised by the relevant Member State authorities;
- supplied only to healthcare workers, and not enter regular distribution channels; and
- available only for the duration of the current COVID-19 pandemic.
This means that the flexibilities under Recommendation 2020/403 will not apply in the context of supplying protective equipment to businesses for distribution to consumers or employees.
The UK has implemented Recommendation 2020/403, to offer a streamlined process for manufacturers wishing to supply PPE to the NHS during the current pandemic. The aim of these routes is to ensure PPE may be supplied within a matter of weeks, rather than going through the usual process for approval, which may take several years.
The UK has also gone a step further to allow the placing on the market of PPE intended to protect workers in any environment (not just healthcare workers), even if it has not completed formal conformity assessment procedures including “Type” approval by a Notified Body and having been CE marked. Where manufacturers seek to rely on this flexibility, they must be able to show that they have:
- submitted a formal application to a Notified Body for Type approval and had the PPE accepted into that process; and
- had the Notified Body confirm that the PPE has an adequate level of health and safety in accordance with the essential requirements under the applicable EU regime.
The UK’s Office for Product Safety and Standards (“OPSS”) has published this Guidance to help businesses manufacturing large volumes of PPE navigate the current regulatory flexibilities. OPSS has also published Guidance for small scale manufacturers, including individuals, who may wish to manufacture PPE to support local efforts. This Guidance sets out a step-by-step approach to making PPE, including which standards will need to be followed in order to ensure the PPE is effective. The Guidance encourages businesses to speak to their local Trading Standards for advice on how to ensure they are supplying safe and effective PPE to the public. We anticipate OPSS will publish further guidance on this topic as the lockdown eases and more businesses seek to ensure both their workers and customers are adequately protected.
Cracking down on counterfeits and non-compliant products
Whilst it is widely accepted that measures to alleviate regulatory burdens are needed during a time of crisis, and the majority of EU businesses are using the relaxations in the spirit in which they are intended, it would seem from reports by EU regulators that, unfortunately, others are not.
The UK’s Medicines and Healthcare products Regulatory Agency (“MHRA”) took part in an annual, globally-coordinated operation to tackle the illegal online sale of medicine and medical devices, and this year’s exercise identified a disturbing trend: criminals are taking advantage of the COVID-19 pandemic by exploiting the demand for PPE and hygiene products. Counterfeit face masks and unauthorised antiviral medication in particular were seized in the operation.
This trend has led EU authorities to take steps to crack down on counterfeit and non-compliant products. In the UK, OPSS is coordinating intelligence across the UK’s ports and borders to protect the UK marketplace and healthcare professionals from unsafe products. Authorities in the Netherlands have taken steps to identify counterfeit and non-compliant products and recently recalled 600,000 defective face masks. Consumers are also being asked to play their part and remain vigilant: the World Customs Organisation issued a warning towards the end of March to remind the general public to exercise extreme caution when purchasing critical medical supplies from unknown sources, particularly online.
Keeping up with the crisis
What can we learn from the current actions of PPE regulators in their oversight of the production and supply of PPE products during the COVID-19 crisis?
Irrespective of where they are in the cycle of the pandemic, all countries are mindful of the safety of the PPE that is being used in the fight against the virus. Authorities in China, for example, have been more stringent than ever in assessing products being put on the domestic market to ensure they meet health and safety standards. In EU countries, such as Belgium, there have been reports of authorities rejecting non-compliant facemasks and other PPE, despite dwindling national supplies. Although the UK has taken significant steps to ease usual regulatory burdens, last week also saw the OPSS detaining 700,000 face masks delivered to the UK that it deemed to be non-compliant.
The message is clear: the supply of PPE is critical, but the demand for equipment will not override essential safety requirements. Manufacturers and interested parties should continue to monitor the development of the outbreak and guidance on regulatory easements from authorities to ensure that they are aware of the current position, which changes on an almost daily basis.