In early January, the EU commission put forward a proposal to extend the transition period for certain medical devices and the removal of the sell-off date for IVDR devices due to concerns of medical device shortages and notified body capacity. In February, the EU parliament has voted by a landslide in favour of the proposal … Read more
Toward the end of December 2022, the MDCG published a position paper aimed at providing a common understanding and approach to the application of Article 97 of the MDR. Giving some hope concerning devices that were certificated under the MDD but have expired since May 2021 or will expire before an MDR certificate is issued. … Read more
September 2022 saw the release of this much-anticipated document, it records the agreements reached by the Member State members of the Borderline and Classification Working Group (BCWG) following the exchanges under the Helsinki Procedure under Regulation (EU) 2017/745 on medical devices (the MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). This … Read more
The EU Commission has in place a draft implementing regulation, reclassifying certain active products without an medical intended purpose. Certain devices that fall into the category of High intensity electromagnetic radiation emitting equipment without an intended medical purpose are due to be reclassified to ensure an appropriate conformity assessment of those active products is consistent … Read more
MDCG 2022-11 The EU MDCG have published a Position Paper titled “Notice to manufacturer to ensure timely compliance with MDR requirements”. In summary, the document is really a stern warning to manufacturers who have not yet transitioned to the EU MDR, making it clear that those products which do not comply with the regulation requirements … Read more
The updated Blue Guide was published in the Official Journal of the European Union towards the end of June. It includes updates concerning the implications of Brexit, Regulation (EU) 2017/745 & (EU) 2017/746 and more. We have only begun to pick through this new updated text and may have updates on our website in the … Read more
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
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