Whether maintaining constant supplies of personal protective equipment (PPE), medical devices and pharmaceuticals or finding the vital vaccine needed to rid us of the effects of the virus, the healthcare and life sciences sector is playing a vital role during the COVID-19 crisis. It is also continuing to have a profound effect on our hospitals, hospices, nursing homes and voluntary healthcare providers across Ireland.
Our Healthcare & Life Sciences team has unrivalled experience in areas of the healthcare, medic
al and pharmaceutical industries. We have an in-depth understanding of the regulatory landscape, and are keeping abreast of all COVID-19 related changes in procedures and regulations. We can provide practical legal and compliance advice to manufacturers hoping to bring products to market. We are also advising clients on how to progress their medical negligence disputes during this unprecedented time. We continue to provide legal and practical guidance and can steer you through this unfamiliar territory.
Webinar: Software as a Medical Device
21.04.21
We will host an MDR Workshop on Software as a Medical Device on Wednesday, 21 April at 4:00pm-6:00pm Irish time.
Online Conference: Consumer Products in 2021 - Three Key Issues for the Year
23.03.20
We will host an online conference on Tuesday 23 March at 4.00pm GMT which will consider the top three key issues manufacturers and suppliers of consumer products will be facing in 2021.
Webinar: Software as a Medical Device
07.10.2020
In this webinar, our speakers provided practical guidance on how to get software medical devices onto the European market under the upcoming MDR and also did a deep dive on new obligations arising under the MDR.
Webinar: The EU Regulation of Wearables – A Changing Landscape
07.07.20
We hosted a webinar on Tuesday 7 July on key legal considerations for the wearables industry in the EU.
Mandatory COVID-19 Vaccines for Children?
19.03.2021
COVID-19 vaccines have brought much needed relief in the fight against a global pandemic that has dramatically changed life in Ireland since March 2020
The Medical Devices Regulation – Where Are We Now?
23.02.2021
The Medical Devices Regulation (MDR) represents a significant development of the existing regulatory system for medical devices in Europe and will replace existing Directives which have been operative for over 25 years.
The New Consumer Agenda
19.02.2021
The European Commission (the Commission) launched its ‘New Consumer Agenda’ on 13 November 2020 (the Agenda), to further empower European consumers in the green economy and the digital transformation of the single market.
The Regulation of Hand Sanitizers During COVID-19
29.06.2020
Due to COVID-19 the demand for hygiene products such as hand sanitizer has escalated beyond supply. We discuss some of the necessary legal considerations for producing hand sanitizer at present.
How COVID-19 is Impacting Healthcare Litigation
15.06.2020
The progress of healthcare litigation has not been immune from COVID-19 disruptions. The Courts Service of Ireland has been adjourning personal injury court hearings and motion lists unless urgency can be shown. As a result, all parties involved in healthcare litigation now face a number of additional obstacles.
The Role of Wearables in the Battle Against COVID-19
28.05.2020
We look at what role wearable technology can play and the legal issues that may arise for manufacturers of wearables when used for this purpose.
COVID-19 Corporate Update: Next Steps for the Irish Nursing Homes Sector
29.05.2020
The Irish Minister for Health Simon Harris announced in April 2020 new measures to help tackle the rising COVID-19 crisis in nursing homes. This temporary scheme is intended to help nursing homes financially with up to €72 million available in supports over a three-month period (the Scheme).
The Role of Wearables in the Battle Against COVID-19
28.05.2020
The contagious nature of COVID-19 has made screening, monitoring of patients and detecting the early signs of the virus extremely difficult. As a result, the European Commission has recommended that digital technologies play a valuable role in the battle against the virus. We look at what role wearable technology can play and the legal issues that may arise for manufacturers of wearables when used for this purpose.
Healthcare & Medical | Charitable Healthcare Organisations Required to Adopt Charities Governance Code
22.04.2020
At a time when many healthcare organisations are overrun dealing with the current pandemic, some other members of staff have time on their hands. It may be that those staff members have the skills to assist in compliance with the Charities Governance Code.
Public, Regulatory & Investigations | COVID-19 - Measures Introduced to Increase the Number of Healthcare Workers in Ireland
22.04.2020
A number of steps have been taken in Ireland to increase significantly the number of healthcare workers in light of the COVID-19 pandemic.
The Health Service Executive (HSE) launched the ‘Be on call for Ireland’ recruitment drive on 17 March 2020. The Chief Executive of the HSE, Mr Paul Reid, announced that the health service is looking for qualified healthcare workers including medical, nursing and therapy personnel as well as healthcare assistants as part of the recruitment campaign. The HSE later announced on 10 April that there will be an increase in the annual intake of medical interns this year, from 734 to approximately 1,100. This number would depend on how many students pass their final exams and accept an internship offer.
Life Sciences & Product Regulation | HPRA Updates Guidance on Clinical Trials During COVID-19
22.04.2020
The Health Product Regulatory Association (HPRA) is responsible for protecting and enhancing public and animal health through the regulation of medicines, medical devices and other health products. The HPRA is cognisant of the fact that sponsors and investigators may need to alter their approach to clinical trials, to take account of changing circumstances in light of COVID-19. In its most recent guidance issued on 2 April, the HPRA has stressed that in doing so, parties may not abandon the trial protocol. The urgent safety measure mechanism, provided for under current legislation, may be used by the parties where deviations from the protocol need to be made prior to relevant ethics committee or HPRA approval being obtained.
Healthcare & Medical | To Detain, or Not to Detain? Detention Powers of Healthcare Providers During COVID-19 Crisis
22.04.2020
The ongoing COVID-19 pandemic has given rise to drastic changes in all walks of life, to protect public health. But what happens when an individual refuses, or is unable, to follow public health advices, to the extent that members of the public are put at risk? We consider both the old and new legislative powers of healthcare professionals to detain affected persons under the Health Act 1947.
Life Sciences & Product Regulation | Manufacturing Medical Devices and PPE for COVID-19 - 5 Key Considerations
22.04.2020
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.
Life Sciences & Product Regulation | EU Relaxes Rules for Critical Medical Devices to be Placed on the Market
07.04.2020
Many manufacturers are working tirelessly to produce medical devices to protect patients and healthcare providers. Harmonised standards in the EU will now allow high performing devices to be placed on the market with a faster and less expensive procedure for manufacturers. We examine the practical implications of these measures.
Mediation | Courts Close but Remote Mediation can be the ‘New Normal’
07.04.2020
The COVID-19 pandemic means we are living and working in unprecedented times. For now, the pandemic has changed how we work, but we have adapted. We look at how we continue to resolve disputes in this “new normal”.
Public, Regulatory & Investigations | COVID-19 – Do Normal Standards of Practice Apply?
09.03.2020
We examine the approach adopted by UK statutory health and care regulators to professional regulation in light of the COVID-19 outbreak and consider the Irish position.
Healthcare & Medical | COVID-19: A Notifiable Disease – Guidance for Medical Practitioners
06.03.2020
Medical practitioners, including clinical directors of diagnostic laboratories, who diagnose COVID-19 or suspect that a patient under their care is a carrier of the disease, should now be aware of their notification requirements.
