A Q&A document on the EU Regulation’s Unique Device Identification (UDI) system has been published to answer some of the most burning questions when it comes to the application of UDI to medical devices and IVDs. The document covers the following themes: UDI-DI. Basic UDI-DI (BUDI). UDI Labelling. UDI Rules for System and Procedure Packs … Read more
On 26 May 2021, the Medical Device Regulation (EU) 2017/745 (MDR) began to apply following a 4-year transition period from the previous Active Implantable Medical Device Directive 90/385/EEC (AIMDD) and Medical Device Directive 93/42/EEC (MDD). The ‘Transitional Provisions’ within Article 120 of the MDR govern this switch and lay out specific derogations from the Regulation … Read more
Hopefully, the answer is yes. May 26th, 2021 is only a matter of months away and time is short. Please remember Advena Ltd is well placed to help those clients who do not have the necessary resources, either internally or local to their operation. We have a team of consultants, based in our offices both … Read more
It would seem like there will be a considerable number of medical devices compliant with the MDD on the market after 26 May 2020. To compensate, the Article 120(3) of the MDR requires that such devices opting for this ‘legacy route’ meet certain conditions: From 26 May 2020: The device continues to comply with the … Read more
The EU’s medical device regulations 2017/745 and 2017/746 require that each device placed on the market must be accompanied by a unique device identification (UDI) which shall be used for identification and traceability purposes. Note, this requirement applies to all devices apart from custom-made and investigational devices. The above is the proposed symbol to be … Read more
There are several devices that currently do not require a CE certificate under the Directives, which will need certification under the EU MDR by 26 May 2020 for continued market access. This may be due to up-classifications (e.g. some software that is currently Class I under MDD but are Class IIa or higher under MDR) … Read more
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
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
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