Manufacturers of Class I Reusable Surgical Instruments must now obtain a CE certificate under Annex IX Chapters I & III or Annex XI – Part A (limited to the re-usability aspects, as appropriate) by no later than May 26th, 2020 for these devices. Failure to do so will exclude them from placing these devices on … Read more
As many of you will now know, the Conservative & Unionist Party have elected a new leader in Boris Johnson, who has also become the UK’s new Prime Minister. The new Prime Minister has clearly laid out his plans for the timetable of Brexit, in as much as that he and his team of cabinet … Read more
In early June, the European Commission (EC) announced the four issuing entities for the Unique Device Identifier (UDI): GS1, the Health Industry Business Communications Council (HIBCC), ICCBA Informationsstelle für Arzneispezialitäten (IFA GmbH). The decision was made with the help of the Medical Device Coordination Group (MDCG) after the four companies were found to meet all … Read more
Advena are exhibiting at FIME 2019, this trade fair is considered one of the most important across the Americas and is taking place at the Miami Beach Convention Center in Florida. Advena will be located at booth B45 in the gold zone, at this important show in Miami from 26th to 28th June 2019. We … 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
Advena Limited, Malta have chalked up a remarkable success! Following the successful re-certification audit at our UK office at the end of February 2019, the next task was to audit our office in Malta (an EU27 member state) for inclusion on our ISO 13485:2016 certification. Advena’s experts set about this tricky task providing carefully planned advice … Read more
Advena will be located in Za’abeel Hall 4, Stand Z4 J43 at this important show in Dubai from 28th to 31st January 2019. We will be available to meet existing and prospective clients during this trade show. We advise those who would like to meet one of our team to email for an appointment (info@advena.mt) … 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
Software within the healthcare industry is exploding with innovation so much so that regulation is only now starting to catch up!, making software key to a medical device revolution. Software is now incorporated within many medical devices including smartphones. This means that such software and applications must abide by the relevant EU legislation and must … Read more
There is considerable uncertainty regarding the commercial impact of Brexit and how this will affect medical device manufacturers who CE mark devices and use a UK based EU Authorised Representative (EC REP) and label their devices with a UK address. Here at Advena we track the UK political news closely and feel now that unless … Read more
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