The HPRA provides information on this webpage related to COVID-19 and the regulation of medical devices.
During this time, the vast majority of HPRA staff are working remotely. Where possible, please correspond with us by e-mail using existing HPRA staff e-mail contacts or via relevant mailboxes. Please see Contact Information for Medical Devices for additional details, including emergency contacts.
The HPRA is working in partnership with the Department of Health and the HSE to minimise and proactively address any risks posed to the ongoing supply of medical devices to Irish health institutions and patients. This work programme involves liaising closely with industry stakeholders, including representative bodies, manufacturers and distributors, so that there is continued access to the devices used by healthcare professionals to diagnose and to treat patients with Covid-19.
The most recent updates are listed first. Please click on an item to see more information.
6 April 2020 – Regulation of Hand Sanitiser
Hand sanitisers that make general claims in relation to an antibacterial action or killing of germs (and do not make medicinal claims or contain medicinal substances) are classified as biocides and regulated by the Pesticides Registration and Control Division in the Department of Agriculture, Food and the Marine.
Soaps intended to clean and/or moisture the hands are likely to be considered as cosmetic products, regulated under European Regulation (EC) No. 1223/2009.
Hand sanitisers that contain medicinal substances and are presented as treating a disease or preventing a virus or an infection should be classified as a medicine.
More information is available in our news item. The news item includes links to European Commission COVID-19 guidance on hand sanitisers.
3 April 2020 – Regulation of Face Masks and Gloves
The regulation of face masks and gloves differs depending on the product type and its intended purpose. Face masks and gloves may be considered personal protective equipment (PPE), medical devices or, in some instances, they can be considered both.
More information is available on our website regarding the regulation of PPE, medical devices, and dual purpose masks and gloves. The webpage also includes links to European Commission Covid-19 guidance for PPE.
30 March 2020 – EU Commission Proposal on MDR Delay
The Medical Device Regulation (MDR) was due to become fully applicable on 26 May 2020. However, the outbreak of COVID-19 has placed unprecedented and unexpected pressures on economic operators, notified bodies and competent authorities.
With the above in mind, and the acknowledgement that patient health and safety are central to the work of the MedTech sector, the European Commission announced on 25 March 2020 that work on a proposal to postpone the application date of MDR for one year is ongoing. The Commission aims to submit this proposal in early April to the Parliament and Council for adoption before the end of May.
This proposal will allow competent authorities, notified bodies, manufacturers and other stakeholders to focus fully on urgent priorities related to the COVID-19 outbreak.
Further information on the Commission’s announcement can be found here.
27 March 2020 – Falsified diagnostic tests for COVID-19
The HPRA is aware of falsified tests for the diagnosis of COVID-19 (SARS-CoV-2) circulating
in Europe but has no evidence to date of their availability in Ireland. Falsified tests are fake or
counterfeit tests that vendors pass off as real and/or certified.
Current HPRA advice, in line with the NPHET strategy, is that members of the public
should not purchase tests for COVID-19 online or from any other retailer.
These tests may provide incorrect results.
The HPRA wishes to advise that currently all testing for COVID-19 in Ireland is
under the direction of the NPHET and conducted in the National Virus Reference Laboratory
(NVRL), in a number of hospital diagnostic laboratories and other designated laboratories. All
samples are currently taken by healthcare professionals in a community test centre or in the patient’s home. The HPRA would like to reiterate the importance that all testing in Ireland is
aligned with this national approach and is transparent to ensure that:
- test results are reported to the relevant stakeholders (for monitoring and surveillance purposes);
- contact tracing activities are initiated (where appropriate); and
- an incorrect test result does not lead to false reassurance resulting in individuals failing to seek the necessary medical help. During this time, the individual may also unknowingly spread the virus.
Please see our Information Notice for further details.
26 March 2020 – Revised European Harmonised Standards for Medical Devices
The European Commission adopted decisions 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 device manufacturers to demonstrate conformity to the EU Medical Devices Directive, 93/42/EEC and provide companies with easy and direct access to the internal market for their products, while ensuring a high degree of safety for users and consumers. The standards cover the devices listed below:
- Medical face masks (EN 14683:2019)
- Surgical drapes, gowns and suits (EN 13795:2019 parts 1 and 2)
- Washer-disinfectors (EN ISO 15883:2018 part 4)
- Sterilisation (EN ISO 13408:2018 and EN ISO 25424:2019)
The standards are available for free download from the websites of CEN national members.
Further information is available on the Commission website.
24 March 2020 – Derogation based market access for non-CE marked medical devices for COVID-19
The HPRA has developed a process for the urgent assessment of applications to use non-CE marked medical devices in Ireland, in the context of the COVID-19 emergency. The HPRA assesses these devices to determine whether the provision of non-CE marked devices is in the interest of the protection of health.
To apply for this derogation, please complete a manufacturer and a consultant application form.
This process is unique to Regulatory Derogations specifically for the management of the Covid-19 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 use of a single device.
The HPRA will conduct an initial review of the submission and will work with the consultant and manufacturer applicant to complete the review as quickly as possible.
To assist with the review, please provide information regarding the device, its regulatory status and standards which have been applied.
If you have any queries regarding this process, please contact email@example.com.
23 March 2020 – European Union Export Controls for Personal Protection Equipment (PPE)
The European Commission has introduced an Implementing Regulation setting out emergency export controls on Personal Protective Equipment (PPE). The categories of PPE items subject to control are listed in Annex I of the Regulation and include masks, gloves, gowns and eyewear. While this Regulation does not restrict the free circulation of PPE within the single market, prior authorisation will be required in order to export items on the list to countries outside the EU. A number of countries are exempt from this Regulation including the UK for the duration of the Brexit Transition Period, Norway, Iceland, Lichtenstein, Switzerland, Andorra, the Faroe Islands, San Marino, the Vatican City and the countries and territories listed in Annex II of the Treaty on the Functioning of the European Union.
This measure is intended to assist EU health authorities in responding to the Covid-19 outbreak by protecting the supplies of PPE within the EU. These controls came into force on 16 March 2020 and will apply for a period of six weeks.
Businesses wishing to export items on the list outside the EU must apply to the Department of Business, Enterprise and Innovation for authorisation. Details on the application process can be found on the Department of Business, Enterprise and Innovation’s website.
Further information regarding the practical application of the Regulation can be found in the Commission’s guidelines to assist businesses in the practical implementation of the Regulation.
19 March 2020 – Regulation of Hand Sanitisers and Face Masks
Hand sanitisers that make general claims in relation to an antibacterial action or killing of germs (and do not make medicinal claims or contain medicinal substances) are classified as biocides and regulated by the Pesticides Registration and Control Division in the Department of Agriculture, Food and the Marine. Please contact firstname.lastname@example.org if you have any queries on registration of biocidal products for hand sanitisation.
Additional Update: On 30 March, the European Commission published guidance on the applicable legislation for leave-on cleaners and hand disinfectants (gel, solution, etc.) for operators including small and medium-sized enterprises, which can be found on the European Commission website.
Face masks are classified as Personal Protective Equipment (PPE) where they are to protect the user from inhalation of hazardous substances. The Health and Safety Authority (HSA) is responsible for PPE and there is information on respiratory PPE available on its website. Surgical face masks are classified as medical devices where they are intended to be used in a medical, surgical or dental setting. Surgical masks that qualify as medical devices should be CE marked in accordance with the Medical Devices Directives (93/42/EEC).
13 March 2020 – In-vitro Diagnostic Test Kits for COVID-19
The National Public Health Emergency Team (NPHET) is coordinating the management of and response to COVID-19 in Ireland.
All testing for COVID-19 in Ireland is currently conducted in the National Virus Reference Laboratory (NVRL) and in a number of regional laboratories on samples taken by healthcare professionals. Any decision to change from the current testing strategy will be directed by the NPHET. Members of the public are advised to follow the HSE guidance in respect of testing. This is available on the HSE website.
The current testing strategy in Ireland, based on expert advice, involves laboratory based pathogen detection using nucleic acid technology (NAT) methods (PCR). Our experts agree that serological assays currently cannot compete with molecular diagnosis, particularly in the early phase of infection. This is particularly marked in those who are immunocompromised, and in the elderly.
Stakeholders (manufacturers, distributors) should contact the HPRA prior to supplying IVD test kits for COVID-19 to the Irish market. As this is a rapidly evolving situation, the HPRA can advise if a particular test is in line with the national strategy for COVID-19 testing in Ireland at a point in time. Queries can be submitted to our medical devices team at email@example.com.