The COVID-19 pandemic has brought about an unprecedented strain on resources in Ireland and all around the world. Shortages in medical devices, from ventilators to face masks, gowns and disinfectors have been widely reported. Many manufacturers, including traditionally non-medical manufacturers have been working to mass supply medical devices to assist in the crisis.
However, medical devices are heavily regulated and manufacturers should be aware of the onerous obligations they are subjected to under the regulatory regime. Medical devices must be approved by a notified body prior to being put on the market. This process is generally time consuming and can cause delays. Due to the unprecedented nature of the current crisis, regulators are now streamlining the process to allow devices to be put on the market as soon as possible to protect patients, healthcare providers and society.
EU Response – harmonising standards
To respond to the urgent demand, the European Commission has adopted decisions on harmonised standards which will allow manufacturers to place high performing devices on the market. These standards facilitate a faster and less expensive conformity assessment procedure. The revised harmonised standards apply to critical devices such as:
- Medical face masks
- Surgical drapes, gowns and suits
This represents an additional measure taken by the Commission to respond to the coronavirus outbreak. Also upon the urgent request of the Commission, the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC), in cooperation with their members made available a number of European standards for certain medical devices and personal protective equipment.
The Irish response
The Irish regulator, the Health Products Regulatory Authority (HPRA) continues to work remotely, and has a dedicated section of their website to keep stakeholders informed of developments related to COVID-19 and health products.
The HPRA has developed a process for the urgent assessment of applications to use non-CE marked medical devices in Ireland during the COVID-19 crisis. The HPRA will assess devices to determine whether the provision of non-CE marked devices is in the interest of the protection of health.
This process is unique to Regulatory Derogations specifically for the management of the pandemic. The HPRA also has a compassionate use process for authorisations in accordance with article 11.13 of the Medical Devices Directive, which applies to an individual patient's use of a single device.
The HPRA have committed to completing their reviews as quickly as possible and will work with applicants to get products to market.
How we can help
Our Life Sciences and Product Regulatory team has particular experience in the medical devices sector. We have an in-depth understanding of the regulatory landscape, and are keeping abreast of all COVID-19 related changes in procedures. We can provide practical legal and compliance advice to manufacturers hoping to bring a product to market to help in the fight against this pandemic. We are familiar with the HPRA procedures and can guide manufacturers through the new derogation process.
For more information on how we can help, please contact a member of our team who will be able to guide you.
The content of this article is provided for information purposes only and does not constitute legal or other advice.