As the spread of COVID-19 continues to have a significant impact on all industries and sectors worldwide, many manufacturers are looking to assist and to develop new products during this emergency. Despite the rush to help, there are a number of regulatory considerations that manufacturers should be aware of.
Under normal circumstances, medical devices cannot be placed on the market without a CE mark. Obtaining regulatory approval and certification for medical devices before placing the product on the market can take a number of months. The Irish regulatory authority for medical devices, the Health Products Regulatory Authority (HPRA), has however introduced a relaxation of the rules to permit certain non-CE marked medical devices relevant to the COVID-19 emergency to be supplied in certain circumstances. The process involves an urgent assessment of an application to place devices on that market that could help during these unprecedented times.
The HPRA will assess the device to determine whether its provision is in the interest of protection of health, despite the fact it is not yet CE marked. This process is unique to regulatory exemptions and is specifically for the management of the COVID-19 pandemic only.
Separately, the HPRA has also advised that manufacturers and distributors of In-Vitro Diagnostic Test Kits for COVID-19 1 should contact the HPRA prior to supplying the testing kits to the Irish market. The HPRA has stated that it can advise if a particular test is in line with the national strategy for COVID-19 testing in Ireland at a particular/given point in time.
Revised European harmonised standards for medical devices
The European Commission has also reached a decision on harmonised standards for medical devices to respond to the urgent need for high performing devices to be placed on the European market. The agreed standards allow medical device manufacturers to show conformity to the relevant medical device regulations and will make it easier for companies to gain direct access to the internal market for their products, while also ensuring a high degree of safety for users and consumers.
Examples of some of the devices covered include:
- Medical face masks
- Surgical drapes, gowns and suits
To ensure a quick response to the increased demand for medical devices and PPE generated by COVID-19, the European Commission has agreed with the European standardisation organisation that 14 standards can now be accessed for free and will be fully available by the national standardisation bodies.
Personal protective equipment (PPE)
According to current estimations by the World Health Organisation “PPE supplies across the world need to be increased by 40%”. The urgent requirement for PPE has resulted in a number of companies adapting their businesses to help in this crisis in remarkable ways.
Manufacturers should, however, be mindful of certain regulatory issues once PPE production begins.
Face masks and gloves – PPE or medical devices?
Face masks and gloves are just two of the essential products that are designed to ensure protection against COVID-19 for frontline workers. But how are these products regulated?
Face masks and gloves may be considered as PPE or medical devices and sometimes, they can be classified as both if they have a dual purpose. Their regulation will differ depending on the type of product and the manufacturer’s intended purpose for the product. If the product is intended to have a dual purpose it will fall within the scope of both the PPE Regulation 2 and the Medical Device Directive (MDD) 3 or the Medical Device Regulation (MDR).4
The product must comply with the legal requirements of the MDD or MDR and relevant basic health and safety requirements of the PPE legislation. Manufacturers are encouraged to assess on a case-by-case basis the intended purpose of their device and to determine what specific safety requirements will apply.
CE marks for PPE
In the context of COVID-19, the European Commission has issued guidance to facilitate the uptake of new PPE products on the EU market. As part of this guidance, the Commission has urged all notified bodies, including third party testing bodies, to prioritise any new requests submitted by manufacturers for COVID-19 related products.
The Commission has also provided for certain scenarios in which products may be placed on the market even if the conformity assessment procedures have not yet been finalised or, in certain circumstances, have not even commenced.
Firstly, if national market surveillance authorities find that the equipment ensures an adequate level of health and safety in accordance with the essential requirements set out in EU law, they may authorise these products on the EU market, even though the conformity assessment procedures, including the affixing of CE marking, have not been fully finalised.
Secondly, in exceptional circumstances, products can be placed on the market even if the certification procedures have not been initiated and no CE marking has been affixed upon them, if the following cumulative conditions are fulfilled:
- The products are manufactured in accordance with one of the EN standards or in accordance with any of the other standards referred to in the WHO guidelines or a technical solution ensuring an adequate level of safety
- The products are part of a purchase organised by the relevant Member State authorities
- The products are only made available for the healthcare workers
- The products are only made available for the duration of the current health crisis, and
- The products are not entering the regular distribution channels and made available to other users
Finally, manufacturers should be aware of the risks involved when placing unregulated products on the Irish market. The supply of unregulated products not authorised to be on the market may result in enforcement action taken by the HPRA and withdrawal of the product from the market given the health and safety risks involved for members of the public. In addition, manufacturers should be mindful that under Irish product liability law, there is a risk they may be found liable for damages where a product is considered to be defective. Therefore manufacturers must remember their obligation to provide safe products to the public.
A number of Irish manufacturers across the country have been adapting and modifying their businesses over the past few weeks to assist healthcare frontline workers in the fight against COVID-19 by developing new innovative products. From an early stage in production, companies should identify whether the product they are manufacturing is, in fact, a medical device or PPE, or both. Manufacturers should have a clear understanding of the regulatory path the product must follow and what derogations are permitted.
Product liability issues are also something that businesses should think about before deciding if they want to commence production of medical devices or PPE.
For more information, please contact a member of our Product Regulation & Consumer Law team.
The content of this article is provided for information purposes only and does not constitute legal or other advice.