NEWS
European Commission to delay IVDR
The European Commission is proposing an extension to the transition period for the forthcoming In Vitro Diagnostic Medical Devices Regulation (IVDR), with the aim of ensuring continued availability of essential healthcare products. The Commission is also proposing
measures to enhance transparency in the medical device sector including by speeding up the launch of some elements of the European Database on Medical Devices (EUDAMED). The IVDR has been applicable since May 2022 and aims to modernise and upgrade the EU framework for in vitro diagnostics (IVDs) to ensure their safety for patients. However, the available data shows that many IVDs currently on the market do not yet comply with the new rules. To improve the availability of such devices, this latest proposal will give more time for manufacturers to apply the new rules, under certain conditions, without compromising safety requirements. Under the current provisions, these rules would apply from 26 May 2025 for high risk IVDs or 26 May 2027 for lower risk IVDs. The additional time granted to companies depends on the type of device. The proposal also requires manufacturers to give prior notice if they foresee the interruption of supply of IVDs or medical devices. The European database on medical devices, EUDAMED, is key for the effective and efficient implementation of the Medical Device and IVD Regulations. It will increase transparency in the EU, providing an overview of all medical devices available on the European market. Today’s proposal aims to speed up the launch of the parts of EUDAMED that are already finalised, so that it is mandatory from late 2025. The Proposal will now be put forward to the European Parliament and Council for adoption. The Commission will begin its
preparatory work for a targeted evaluation of the legislation on medical devices this year. The evaluation should assess how the legislation is affecting the availability of devices, as well as looking at the additional costs and administrative burden linked to the implementation of legislation, especially for small to medium enterprises.
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UK set to miss out on HealthTech innovations
Persistent regulatory ambiguity and NHS procurement processes mean the UK is at risk of missing out on the latest HealthTech innovations, the latest survey of the industry reveals. The data, captured by the Association of British HealthTech Industries (ABHI) and CPI, in the report The Pulse of Healthtech: 2023 Business Survey highlights that these barriers are now having a tangible impact on the ability of the sector to bring HealthTech to the UK. The regulatory uncertainty experienced has now led to almost half of businesses removing products from the UK market, and over a third of companies have chosen not to bid on specific tenders due to unworkable procurement requirements. Challenges have also been compounded by cost pressures to businesses, with over 77% of respondents highlighting that the cost to serve the NHS had increased over the last year.
Despite these challenges, companies do rate the UK as highly as anywhere in the world in the willingness of the health system to collaborate with industry. Changes are, however, needed to realise the full value
Atom Scientific brings Falc products to the UK
Atom Scientific has announced a new distribution partnership with Falc Instruments for the UK, adding the Italian company’s laboratory equipment to its already extensive range.
Falc Instruments was founded in 1973 in the industrial area of northern Italy and the company now has over 50 years’ experience in the manufacture of high-quality equipment for scientific laboratories. Falc’s ultra-modern facility is certified to UNI ISO 9001 – VISION 2000 and produces high quality, high precision, yet affordable temperature control
equipment to suit all applications, such as stirrer hotplates, heating mantles, block heaters, ovens and water baths. The range also includes robust and
reliable agitation products including shakers, rockers rollers and rotators. Quality is at the heart of every product, supported by a long-standing tradition of technical expertise to meet and exceed customer’s expectations. See the products on the Atom Scientific website at
www.atomscientific.com.
FEBRUARY 2024
WWW.PATHOLOGYINPRACTICE.COM
of HealthTech, which has been recognised by the Government as a key driver for the improvement of the health and wealth of the UK. The survey’s data findings also indicate positive sentiment towards early-stage research support,
elements of the local skills base and the opportunity that AI presents. Peter Ellingworth, Chief Executive, ABHI,
said: “These issues will not be news to anyone within our industry, and those who work to support it, but what is stark is the level of innovation that is at risk of not reaching UK patients. We operate in a global industry, and if we are serious about making the UK a destination market for HealthTech innovation, as outlined in the Life Sciences Vision, we must do things differently in order to remain competitive. The survey supports that there is a vast opportunity to realise the full potential of the sector and positive work is underway to realise it.”
The survey captures data from
HealthTech businesses operating in the UK. Further details, and the full survey report, can be accessed at
https://www.abhi.org.uk/ media/15qkybzf/survey-report-05.pdf.
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