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developers and manufacturers exists in the FDA’s response to 2016 “21st Century Cures Act”, with publication of a draft Guidance document outlining the agencies planned changes to the medical device approvals process and their oversight activities.