European Union Responds to PPE Need During COVID-19 Crisis

The coronavirus outbreak has had and continues to have an immense impact on multiple different sectors and industries globally. While some industries are facing massive cutbacks, others, such as manufacturers of personal protective equipment (PPE) are seeing a surge in demand unlike ever before. Countries all over the world are reporting mass shortages of facemasks, gloves, surgical gowns and eyewear protection. Manufacturers in this space are responding by expediting production and producing larger volumes of product. Manufacturers whose usual business is slowing down have also turned to the production of PPE as a means to protect both the lives of the population desperately in need of such equipment and their own livelihood.

The existing EU regulatory regime applicable to PPE items is particularly complex. Depending on the intended purpose of the product and the time at which it was placed on the market (which is particularly relevant in the context of COVID-19), these items may fall within the scope of either or both of the following EU product safety regimes:

• The PPE regime, which covers design, manufacture and marketing of PPE under EU Regulation 2016/425 (PPE Regulation).

 

• The Medical devices regime, which aims to ensure the safety and efficacy of medical devices across Europe, governed currently in principle by Council Directive 93/42/EEC of June 1993 concerning medical devices, which soon will be replaced by a new legislative regime that, due to COVID-19, has had its date of application delayed a year until 26 May 2021.

Both regimes apply a risk-based classification of products and contain escalating regulatory requirements based on these risk profiles, a requirement to comply with complex conformity assessment procedures, mandatory CE-marking requirements and, often, the involvement of notified bodies.

Recognising the crucial need for such items to be able to respond to the global pandemic and the complexity of applicable regimes, the European Commission has taken steps to alleviate the regulatory burden on existing and pivoting manufacturers. In doing so, the European Commission has made it clear that any relaxations afforded will not be at the expense of the quality of the products and the safety of the users, which is equally important in the current context. All initiatives are aimed at striking a balance between the paramount consideration of ensuring that only safe PPE that adequately protects users is placed on the market with the necessity for such items to be made swiftly available.

The European Commission's approach to increasing the production and supply of PPE in the EU is three-fold:

• Identifying and applying support measures to increase the existing manufacture of PPE in the EU.

 

• Involving PPE companies who were not previously active on the EU market in EU PPE supply.

 

• Converting production lines of EU manufacturers in other sectors (such as the textile sector) to produce PPE.

To reach these goals, the EC, alongside other relevant organisations, has introduced a number of initiatives, including:

• Together with the European Committee for Standardisation (CEN), making fully and freely available all relevant European harmonised standards.

 

• Recommending the use of harmonised standards to place new products on the market as a means to speed up production timeframes by benefitting from the presumption of conformity.

 

• Providing guidance aimed at prospective manufacturers on the production and importation of PPE. The guidance document provides for a broad overview of the main regulatory requirements for making PPE available on the EU market. It outlines relevant regulatory regimes (namely PPE and medical devices above), the applicable technical standards and testing, authorisation processes, CE-marking requirements and materials requirements.

 

• Providing guidance to assist in the classification of borderline products to determine if they fall under the medical devices regime, the PPE regime or both. The guidance states that:
  • Disposable and re-usable face masks, coveralls, gloves and eyewear which are used to protect against harmful agents including viruses fall within the scope of the PPE Regulation.
  • Surgical masks, examination gloves and some surgical gowns fall within the scope of both the PPE medical devices regimes and need to conform to requirements of both.
• Providing confirmation that any items, which are considered medical devices, will likely be classified as ‘Class I products', unless specific rules apply.

 

• Recommending the following actions to assist with conformity assessment under the PPE Regulation:
  • Notified bodies should prioritise swift conformity assessments for requests by economic operators.
  • PPE products not conforming to the harmonised standards, notified bodies should take WHO recommendations as a reference for their technical assessment.
  • Notified bodies who issue certificates should immediately inform relevant authorities and other notified bodies as part of coordination under the PPE Regulation.
• Recommending the following steps to ensure the continued focus on market surveillance activities designed to detect non-compliant PPE and medical device products that raise serious risks of health and safety to users:
  • Market surveillance authorities may authorise products for the EU market without finalised conformity assessment procedures if the equipment ensures an adequate level of health and safety in line with EU legislation.
  • In exceptional cases, purchases organised by EU countries for healthcare workers may skip necessary conformity assessment procedures for equipment, provided that the EU countries' authorities have ensured adequate safety levels.
  • Market surveillance authorities should inform the Commission and relevant authorities urgently of any temporary arrangement through the Information and Communication System for Market Surveillance.

Even before the Commission introduced the above-mentioned initiatives, national authorities were starting to take matters into their own hands. Local authorities on a global scale have put in place various emergency measures to deal with PPE shortages, from lifting regulatory requirements on production and limiting exports to simplifying loan procedures and removing administrative fees to create favourable conditions for production. For example, the UK product regulator, the Office for Product Safety and Standards sent out letters to various authorities in late March asking them to streamline the clearance of non-compliant PPE to ensure it meets essential health and safety standards. The letters came as a response to a recommendation issued by the EU Commission on 16 March concerning PPE and medical devices. Other EU countries have put in place similar emergency measures to streamline the distribution process and halt exports of essential equipment.

Globally, the trend in regulation of PPE appears to track closely with the flattening of the COVID-19 case curve. Countries nearing the peak of the coronavirus curve, like most EU member states, have been taking measures mostly aimed at production and supply of PPE, whereas countries who have passed the peak, such as Thailand and Taiwan, have been focusing more on facilitating for businesses and limiting exports.

Irrespective of where countries are in the cycle of the pandemic, all countries appear cognisant of the safety of the PPE 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 apparently non-compliant facemasks and other PPE, despite dwindling national supplies.

The current focus, at least in the EU, appears to be on ensuring that essential health and safety standards are met, but that non-compliance with other less "critical" requirements may be circumvented in exceptional circumstances. Manufacturers and interested parties should continue to monitor the development of the outbreak and the issuance of guidance to ensure that they are aware of the position, which changes on an almost daily basis.

Dispatch from the EU is a monthly feature provided exclusively for PSL subscribers by Cooley LLP, www.cooley.com. For further information about the above, contact Rod Freeman at rfreeman@cooley.com.