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.
For an overview of how the HPRA is responding to the challenges presented by COVID-19, please see our infographic.
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.
8 June 2020 – Caution When Purchasing Thermometers
It has recently come to the attention of the HPRA that a number of thermometers placed on the Irish market do not meet regulatory requirements for medical devices. Such devices may not perform as intended and instances of inaccurate temperature readings have been reported to the HPRA.
The HPRA would like to emphasise that those purchasing thermometers used to measure the temperature of an individual take appropriate precautions such as the following:
- Purchase from a reputable source
- Ensure the medical device has a CE mark accompanied by a four-digit number
- Ensure labelling and information provided with the device is in the English language
Thermometers are considered Class IIa medical devices as per Rule 10 of Annex IX of the medical device directive 93/42/EEC. Class IIa medical devices are required to undergo notified body assessment prior to CE marking. Therefore, thermometers should have a four-digit number displayed alongside their CE mark. This four-digit number represents the number of the notified body who has certified the product as being compliant with European medical devices legislation.
More information is available in available in our Safety Notice.
3 June 2020 – European Commission Guidance Update: Placing Medical Devices and PPE Lawfully on the Market in the Context of COVID-19
In response to the rise in new economic operators producing medical devices and PPE, the European Commission has published guidance on the placing (and making available) of these products on the EU market.
As noted in this document, extraordinary circumstances have led to a rapid increase in the need, and demand, for specific devices and equipment. This has resulted in the involvement of economic operators (such as importers, distributors and manufacturers) who were not previously involved in the supply of these products.
The document is available to download from the website of the European Commission. It may be useful to new economic operators in these areas.
The HPRA is the competent authority for medical devices. However, queries pertaining to PPE should be directed to the Health and Safety Authority.
24 April 2020 – Falsified In-Vitro Diagnostic (IVD) Tests for COVID-19
The National Public Health Emergency Team (NPHET) is coordinating the management of, and response to, COVID-19 in Ireland. All tests are conducted in the National Virus Reference Laboratory (NVRL), in a number of hospital diagnostic laboratories and other designated laboratories. Members of the public are advised to follow the HSE guidance in respect of testing. This is available on the HSE website. Further information on the national testing strategy is available on our IVDs for Covid-19 page.
Stakeholders (manufacturers, distributors) should contact the HPRA prior to supplying IVD tests for COVID-19 to the Irish market as 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 sent to firstname.lastname@example.org.
The HPRA is also 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. Members of the public should not purchase tests for COVID-19 online or from any other retailer. These tests may provide incorrect results which may result in individuals failing to seek the necessary medical help. During this time, the individual may also unknowingly spread the virus. It is also important to note that, to date, there are no legitimate CE-marked tests available for self-testing.
Please see our Information Notice for further details.
22 April 2020 – HIQA publishes Rapid HTA of alternative diagnostic testing for coronavirus 2 (SARS-CoV-2)
The Health Information and Quality Authority (HIQA) has published a rapid health technology assessment (HTA) of alternative diagnostic testing methods for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This work was done to inform the work of the National Public Health Emergency Team (NPHET) in their response to the COVID-19 (coronavirus disease 2019) pandemic. According to the World Health Organization (WHO), diagnostic testing for SARS-CoV-2 infection is critical to tracking the viral spread, understanding epidemiology, informing case management, and reducing transmission.
At the request of NPHET, HIQA investigated the potential usefulness of alternative diagnostic tests for the detection of SARS-CoV-2, whether any of the tests that are commercially available are being used internationally, and identified when the tests could be deployed in the clinical pathway.
Further information is available from the HIQA website. Information on the national testing strategy is available on our IVDs for Covid-19 page.
16 April 2020 – Ventilators used in the treatment of COVID-19: Information collated by the HPRA
The COVID-19 pandemic has increased global demand for the supply of many different medical devices, in particular, ventilators and other critical care equipment. In certain scenarios, some devices may need to be repurposed for the treatment of seriously ill patients. Generally, such use would be considered off-label use, i.e. not in accordance with the intended medical use specified by the manufacturer prior to CE marking. However, the HPRA is aware that for the duration of the COVID-19 outbreak, the repurposing of such devices may be deemed necessary by healthcare professionals to treat patients in need.
It remains preferable that, in as far as possible, health care facilities should use approved CE-marked devices to support patients with respiratory failure. In situations of off-label use, it may be helpful to contact suppliers/manufacturers for information on how best to use their devices.
Through our activities as the competent authority, the HPRA is aware of certain manufacturer information, which might be relevant for healthcare professionals working with ventilators. The information is summarised on our Ventilators information page. This page also highlights specific information that may assist manufacturers of ventilators and anaesthetic machines.
16 April 2020 – EU Commission Working Document - Performance of COVID-19 Test Methods and Devices and Proposed Performance Criteria
This working document has been produced as output of a dedicated project group consisting of representatives of the Commission services (DG SANTE, DG JRC, DG RTD), the European Centre for Disease Prevention and Control (ECDC) and several experts from in vitro diagnostics competent authorities and health technology assessment. DG JRC conducted the literature review and developed the proposed performance criteria. All other parties contributed input to the project and reviewed the document. DG SANTE coordinated the project group.
The aim of this working document was to collect and review publicly available information from manufacturers on commercially available devices for COVID-19 and to review performance assessment studies of test methods and devices for COVID-19 that have been performed by academic institutions, national regulatory agencies, international organisations, health technology assessment (HTA) bodies, reference laboratories, and similar organisations. Moreover, this report proposes performance criteria for different types of COVID-19 test methods and devices.
Further EU Commission COVID-19 publications and guidance in respect of medical devices can be viewed on the Commission website. This includes Commission Guidelines on Testing (published 15 April 2020).
Information on the national testing strategy is available on our IVDs for Covid-19 page.
7 April 2020 – European Commission Guidance for Medical Devices in the Context of COVID-19
On 3 April 2020, the European Commission published guidance on medical devices, active implantable medical devices and in-vitro diagnostic medical devices in the context of the COVID-19 crisis. This document, provided in a Q&A format, seeks to provide guidance on the following points related to medical devices:
- Legal requirements for placing medical devices on the market and compliance verification
Use and source of appropriate standards
- Derogation process and the Commission's suggested considerations
A list of harmonised standards for medical devices with relevance to COVID-19 is also provided in the accompanying Annex of the document. The information outlined in this guidance will assist manufacturers in the production of essential medical devices and ensuring these products comply with the necessary standards. This guidance is available from the Commission's website.
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. Please contact email@example.com if you have any queries on registration of biocidal products for hand sanitisation.
Soaps intended to clean and/or moisturise 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 guidance on the applicable legislation for leave-on cleaners and hand disinfectants (gel, solution, etc.) for operators, including small and medium-sized enterprises.
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.
Respirator face masks and gloves intended to protect the wearer from exposure to airborne contaminants and from hazardous substances are classified as PPE and are regulated in accordance with Regulation (EU) 2016/425. The Health and Safety Authority (HSA) is responsible for the regulation of PPE. Further information, including information on respiratory PPE, is available on the HSA website.
Medical/Surgical face masks and gloves intended to provide a barrier and to protect the patient and hospital staff from direct transmission of infective agents and to be used in a medical, surgical or dental setting are classified as Class I medical devices and should be CE-marked in accordance with the essential requirements of Directive 93/42/EEC on medical devices (MDD).
More information is available on our website relating to 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.
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 firstname.lastname@example.org.
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.