To help combat the threat posed by the COVID-19 outbreak, the European Commission last week announced the publication of new guidance aimed at assisting manufacturers to increase production of essential medical equipment.

The new guidance focuses on three key product areas – 3D printing for products in a medical context, personal protective equipment (such as masks and gloves) (PPE) and hydro-alcoholic cleansers and disinfectants for the hands. This forms part of an EU-wide push to enable European industry to step up manufacturing and availability of PPE and medical equipment in the face of supply chain disruption and enhanced demand.

It follows on from Commission Recommendation (EU) 2020/403 (the Recommendation), published last month, which temporarily relaxes the procedures on conformity assessment and market surveillance and offers practical guidance on its application.

The Recommendation allows for PPE products to be manufactured in accordance with World Health Organisation (WHO) recommendations provided they afford a level of protection sufficient to correspond with safety requirements in the EU.

Market surveillance authorities are also able to allow (for a limited time) the circulation of PPE or medical devices where the conformity assessment procedures, including the affixing of CE marking, have not been fully finalised. This is contingent on the relevant authorities finding that such devices ensure an adequate level of health and safety in accordance with EU law.

The guidance:

• Getting PPE to market: This guidance sets out the steps to be taken to place PPE products on the market. Normally available for purchase from the European standardisation organisations which developed them, fourteen European standards, including EN 149 (FFP-type masks) and EN 14683 (surgical masks) are now able to be downloaded for no charge. Read the guidance here.
• Conformity assessment procedures for 3D printing: This clearly sets out examples of technical standards to enable manufactures to comply with the applicable EU law. Read the guidance here.
• Clear guidance around leave-on hand cleaners: For economic operators looking to expand their operations to include the production of hydro-alcoholic hand cleaners and disinfectants, the Commission has issued valuable guidance around the applicable legal frameworks (either the Cosmetic Products Regulation or Biocidal Products Regulation) and the requirements for each). Read the guidance here.

With this guidance, the Commission is actively looking to bolster market accessibility and ensure that manufacturers have the help they need to ensure their products comply with the necessary safety standards.

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