UK

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 Although they were sufficient for the time, these legislations are becoming increasingly outdated with the advancement in medical technologies.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 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

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

The new guidance on Virtual Manufacturing has been published by the MHRA. The document, titled “Virtual Manufacturing replaces Own Brand Labelling for medical device manufacturers” can be found here[1]. As the title suggests, this replaces the previous OBL guidance and its requirements must be met by 1st September 2017. One of the critical new requirements … Read more

It would have been difficult to miss the recent news (certainly if you’re based in Europe) regarding the UK Government’s delivery of the letter to the EU Commission, invoking Article 50 of the Lisbon Treaty, where a member state officially notifies of its intention to leave the EU, and so the negotiation process begins. So … Read more