Industry News

Keep up to date with the latest news and information from Medilink West Midlands and our members across the Medical Technology and Life Science sectors, together with topical regional, national and international news.

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Impact of the new Medical Devices Regulation & In Vitro Diagnostic Medical Devices Regulation

Featured News
9th July 2019

The regulatory landscape for medical devices is presently very challenging. Industry is well aware that the three year transition period from a directive to a regulation ends on the 15th of May 2020, whereupon the new regulatory framework (MDR) will apply in full. This will be followed in May 2022 with the new IVD regulations.

Polyflon launches its second Class 7 Clean Room

21st June 2019

Polyflon are proud to announce the launch of their brand new Class 7 clean room. The new 60sqm ISO 14644-1 facility, with provision for EU GMP Annex 1 Grade C operation

Brexit and the need of an EU Authorised Representative for UK medical device businesses

26th February 2019

An EU based Authorised Representatives (EC Rep) may be needed if UK device businesses export devices to markets where a CE mark is required, after the 29th March 2019 deadline.

MHRA no-deal Brexit contingency legislation for regulation of medicines and medical devices

30th January 2019

The Medicines and Healthcare products Regulatory Agency (MHRA) have provided details of legislation to ensure continuity of supply of medicines, medical devices and clinical trials in a no deal Brexit.

Letter from Secretary of State to Suppliers of Medical Devices and Clinical Consumables

7th December 2018

Matt Hancock, Secretary of State for Health & Social Care, has written a letter to suppliers of medical devices and clinical consumables to update them on the Department’s contingency planning approach.

Presentations now available for Healthcare Innovation Roadshow

19th October 2018

The Healthcare Innovation Roadshow, in collaboration with the West Midlands Academic Health Science Network (WMAHSN), National Institute for Health Research (NIHR) and Medilink West Midlands, took place on Thursday 18th October 2018, at iCentrum in Birmingham.  The Healthcare Innovation Roadshow showcased the support that can be accessed by MedTech SMEs, from funding and adoption to […]

FDA to use ISO 13485 for medical device quality

13th September 2018

To help streamline regulatory processes for medical devices across the world, the FDA has decided to replace its current system with ISO 13485, the organisation has announced.

9 changes to FDA goalposts for medical devices

6th September 2018

A potential silver lining for medical device developers and manufacturers exists in the FDA’s response to 2016 “21st Century Cures Act”, with publication of a draft Guidance document outlining the agencies planned changes to the medical device approvals process and their oversight activities.

9 Steps to right first time regulatory compliance

24th July 2018

By Medilink member, Three Circles. It can be a scary thought, regulatory compliance. So much to get your head around, so much to make sure is done right, and what is “right” anyway.

Optimising battery design for performance

21st June 2018

Professional battery manufacturer Accutronics (MedilinkWM member) has released an infographic to help original equipment manufacturers (OEMs) optimise their device designs to maximise battery performance.

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