News > Regulatory

22nd September 2020

Safety-critical alerts are changing at the MHRA

The MHRA will now issue all safety-critical alerts for medicines and medical devices that require action as National Patient Safety Alerts The Medicines and Healthcare products Regulatory Agency (MHRA) is changing the way it issues safety-critical alerts to healthcare providers. From now on, all safety-critical alerts for medicines and medical devices that require action to…

18th August 2020

Centre expert advises on US public health emergency preparedness and response

Professor Jane Noyes, from the National Centre for Population Health & Wellbeing Research, was asked to join a US National Academies of Sciences, Engineering, and Medicine review of the current state of the evidence for public health emergency preparedness and response (PHEPR) in the United States. The lessons learned from responding to public health emergencies…

21st May 2020

Creo signs commercialisation agreement

Creo Medical Group has signed a commercialisation agreement with the Department of Health and Social Care to provide NHS Hospitals with access to one its products at preferential rates for a limited period. The medical device company said the agreement relates to its CROMA Advanced Energy Platform and associated devices for use in gastrointestinal therapeutic endoscopy….

05th May 2020

An Opportunity to Support Welsh Firms That Have Fallen Through The Gap

Advice from Professor Dylan Jones Evans, USW Over the weekend, the UK Government announced a further £617 million in funding for the Small Business Grants Fund (SBGF) and the Retail, Hospitality and Leisure Grants Fund (RHLGF). These had previously enabled local authorities to distribute £12.33 billion to businesses as part of the Treasury’s support for…

30th March 2020

European Commission draws up plans to postpone MDR implementation

The European Commission has announced its intention to postpone the implementation of the new Medical Device Regulation (MDR) following the Coronavirus outbreak. The new regulation was due to come into force on 26th May this year but in light of the pandemic, and calls from trade bodies, the Commission has confirmed it is working on a…

12th March 2020

APPG for Life Sciences relaunched

The All-Party Parliamentary Group (APPG) for Life Sciences has been relaunched to assist the government in exploring the challenges and opportunities facing the sector. Pictured left-to-right: Jerome Mayhew MP, Lord Mair, Darren Stenlake (Sysmex), Chris Green MP, Charlotte Casebourne (Theolytics), Haseeb Ahmad (ABPI) and Steve McCabe MP. The first meeting for the group was held…

14th October 2019

Brexit preparation – free webinars

There are less than three weeks remaining before the UK is due to leave the EU. Medilink UK wants to make sure that life sciences and healthcare companies are fully prepared and is hosting a series of FREE webinars around nine different business areas. These 45-minute webinars, designed to help businesses understand the risks and opportunities that…

07th October 2019

Medilink UK and Mediwales to give Wales MedTech businesses detailed guidance on how to prepare for Brexit

Medilink UK, a membership organisation representing over 1350 medical technology and life-science companies, and Mediwales, are hosting a free event on 8thOctober in Cardiff at the Village Hotel (29 Pendwyallt Road, Cardiff, CF14 7EF) to help life science businesses prepare for Brexit. There are over 13,000 life science jobs in Wales and over 1800 in…

26th August 2019

UK Supreme Court approves ‘Skinny Labelling’

The UK’s highest court has held that patents directed towards new medical uses for known products must disclose some sound scientific reasoning or directly relevant experimental evidence in support of the claimed use.  The test for infringement of such patents is likely to depend primarily on the objective appearance and presentation of an allegedly infringing…

19th August 2019

Webinar Follow Up – Regulation of Medical and IVD Devices in relation to EU Exit

Further to the webinar facilitated last week, MHRA have confirmed they are happy for us to share the slides and all relevant links/follow up e-mail to all out MDCC suppliers and trade associations. The Webinar was held on Friday 19th July covering an Update Regulation of Medical Devices and In-Vitro Diagnostic Devices. Please find attached the…