In early March, the MHRA presented a webinar to discuss the upcoming changes to the Medical Device regulations for the UK. From the webinar, it is quite clear that the MHRA is doing their best to align the new regulations with the MDR and IVDR. Various topics were discussed in this webinar and will be … Read more
LNE-GMED (8521) and Scarlet (8536) have just been given approved body status by the Medicines and Healthcare Products Regulatory Agency (MHRA). These new additions bring the total number of UK approved bodies to 9. The full scope of LNE-GMED can be accessed using the following link The full scope of Scarlet can be accessed using … Read more
Currently, the UK MDR is based on the old EU directives, most notably the MDD, IVDD and AIMD. Although they were sufficient for the time, these legislations are becoming increasingly outdated with the advancement in medical technologies. Due to this, the MHRA intends to layout a new regulation that will be closer aligned to the … Read more
The MHRA has designated three new UK approved bodies, almost doubling it’s capacity for the certification of medical devices. There are now a total of seven UK approved bodies in the UK. These approved bodies play an important role in the medical device industry by helping manufacturers to get their device on the market and … Read more
The MHRA recently published its intention to put into place a 12-month extension to the UK’s transitional arrangements. Currently, the UK MDR 2002 states that CE-marked devices will be accepted on the Great Britain (GB) market until the end of June 2023. However, this will now change. The MHRA will introduce an extension to the … Read more
Advena Limited UK, in our continuing endeavour as a leading UK based regulatory consultancy organisation are at the forefront of establishing a new trade association in the UK. Specifically aligned with the UK’s medical device regulations and with direct communication links to the Medicines and Healthcare products Regulatory Agency (MHRA). This new trade association will … Read more
In February 2019, the MHRA published guidance on the use of the ‘UKCA’ (UK Conformity Assessed) mark in the event of a ‘No-Deal’ Brexit. The guidance stated that the UKCA mark would not be recognised on the EU market and manufacturers would still be required to obtain CE marking for products to be placed on … Read more
A publication released by the MHRA on the 4th January, updated on the 26th February explains how the UK will regulate all medical devices under Directive 90/385/EEC on active implantable medical devices (AIMDD), Directive 93/42/EEC on medical devices (MDD) and Directive 98/79/EC on in vitro diagnostic medical devices (IVDD). Whilst all those devices currently CE … Read more
Even now after the draft text of the withdrawal agreement has been agreed by Government, there remains considerable uncertainty regarding the commercial impact of Brexit and how this will affect UK based medical device manufacturers who CE mark devices. As we have done over the last 2 years, we at Advena track UK political news … Read more
There has been a lot of uncertainly about how Brexit is going to affect medical device manufacturers in the UK. Here at Advena we track the UK political news closely and feel now that unless there is significant shift in Westminster a “hard” Brexit may be almost inevitable. This is emphasised by the UK Notified … Read more
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