As noted in our previous overview article and our article on UK-specific guidance for the manufacture and supply of certain medical devices for COVID-19, the regulatory environment for rapid production of COVID-19 medical supplies changes on a daily basis. Most recently, the European Commission has weighed in to provide some Europe-wide insight.

On 30 March 2020, the European Commission produced a series of guidance documents aimed at increasing volumes of essential medical equipment and materials, namely: personal protective equipment (PPE) such as masks, gloves and gowns; 3D printed medical products (including ventilators) and leave-on hand cleaners and disinfectants. These items are recognised as key to the fight against COVID-19.

The user-friendly guidance, written in informal Q&A style that captures recurrent questions from companies, aims to help navigate the extraordinarily complex European regulatory frameworks that ordinarily apply to these types of products. It does so by providing a broad roadmap to placing these products on the European market. The guidance contemplates both EU-based manufacture but also importation, which is interesting in the context of several Member States banning the export of certain medical supplies based on unmet need within the Member State itself.

The Commission makes several statements reiterating the non-binding nature of the guidance and the continued need for companies to ensure for themselves that they are compliant with the regimes. Specific statements, for example on the classification of hand cleaner/disinfectant products based on claims, appear to contradict previous Commission guidance produced in less time-sensitive periods. It is unclear whether these statements intentionally deviate from an earlier position, reflecting a relaxation in approach, or are simply an error. Such examples only serve to underline the significant pressures that all of those in these areas are having to grapple with, as well as the considerable complexity of regulatory regimes.

The guidance documents on products produced as COVID-19 supplies are:

  • Production and importation of protective equipment like face masks, gloves, coveralls and surgical gowns. The guidelines, aimed at prospective manufacturers, provides a whistle-stop tour of the broad requirements for making protective equipment available on the EU market. It outlines the relevant regulatory regimes (namely the PPE and medical devices regimes), technical standards and testing, authorisation. CE-marking and materials requirements. The document underlines the several regulatory pathways that manufacturers may choose to take, based on which relevant voluntary technical standards are selected. It also reiterates the fact that relevant technical standards for these products are being made available free of charge. (See full guidance of 30 March 2020, Conformity Assessment Procedures for Protective Equipment, here).

 

  • Use of 3D printing and 3D printed products for medical use. Prospective manufacturers are again introduced to the applicable legal framework (namely the following regimes: machinery, electromagnetic compatibility, waste electric and electronic equipment, restriction on hazardous substances and chemicals, amongst others). Mandatory harmonised standards, that more directly establish compliance with the regulatory regimes, are set out in detail, as are other non-harmonised standards. Specific technical standards for ventilators (whole products, their components and accessories), which can be produced through 3D printing, are also outlined. With respect to product specifications, prospective manufacturers are advised to collaborate with existing medical devices manufacturers for further guidance, a practice we too encourage more broadly in our previous overview article. (See full guidance of 30 March 2020, Conformity assessment procedures for 3D printing and 3D printed products to be used in a medical context for COVID-19, here).

 

  • Framework for leave-on hand cleaners and hand disinfectants: The regulatory framework (biocidal product regime or cosmetics product regime) is outlined. Given the particular propensity for these products to straddle these two applicable regimes, detailed guidance is given on what might determine the classification of products, particularly in relation to claims about the product. Also, whilst no reference is made expressly in the guidance, it is worth noting that the human medicines regime can apply to these products in some circumstances. Some of the claims referred to in the guidance document would, in fact, normally push the products into the human medicines regime according to previously issued European Commission guidance. It is unclear whether the above position is a specific leniency granted in the circumstances or simply an oversight. (See full guidance of 30 March 2020, ‘Guidance on Applicable Legislation for Leave-on Hand Cleaners and Hand Disinfectants (gel, solution etc.) here).

 

Based on the tone of the above updates, we expect future updates to similarly be compliance roadmaps for manufacturers new to the products they are producing, rather than express statements of regulatory position.

As always, we will keep you updated on future developments on this rapidly changing topic. The EU Commission has so far confirmed that it will be publishing guidance relating to medical devices in the coming days.

 

Posted by Sarah-Jane Dobson

International products lawyer, Cooley LLP