the Implementing Regulation on Common Specifications for the reprocessing of single-use medical devices and the Implementing act on devices without an intended medical purpose (Annex XVI MDR) are in the pipeline and may even be adopted by 26 May 2020, while this concerns essential...
A medical devices company with a substance based device that does the same as some medicines decided to challenge the high VAT rate applied to its products based on violation of the principle of tax neutrality and then ran into what I can only qualify as an impressive exercise in regulatory b...
devicessectorinsupportoftherequirementslaiddownintheapplicableEUlegislation,taking intoaccountitsspecificities. Thecontentsofthisdocument: 1.EUlegislationonmedicaldeviceswithinthe“NewApproach”andthe“New LegislativeFramework” 2.ThegeneralframeworkforharmonisedEuropeanstandards ...
This is nothing new and we knew this from the Court’s quite steady case law in the field (see for example here in relation to the Court’s specific view on additional national liability rules concerning medical devices). Ergo, it’s a national matter said the EU Court, subject to the ...
ANDAMENDMENT 21 ARTICLE20DISPUTESETTLEMENT 22 MedicalDeviceDirective2015i ARTICLE21RESERVATIONS 22 ARTICLE22ENTRYINTOFORCE 22 ARTICLE23ANNEXES 23 ARTICLE24DEPOSITORY 23 ANNEX1EssentialPrinciplesofSafety andPerformanceofMedicalDevices 27 ANNEX2RiskClassificationRulesforMedicalDevices otherthanIVDMedicalDevices 41 ANNEX...
The General Medical Council (Registration Appeal Panels Procedure) (Amendment) Rules Order of Council 2009doi:2009 No. 2752
On November 2023:regulation #161on amendment on rules of clinical trials for medical devices and in-vitro diagnostics in the Eurasian Economic Union. Russian and Eurasian Medical Device Regulations – Highlights 2022 Posted on30.12.2022 Reply
Medical Devices (Amendment) Rules, 2020 Medical Device Status Effective April 1, 2020, the status of a medical device expanded beyond the 23 previously notified medical devices, requiring thatallmedical devices be registered under The Drugs and Cosmetics Act of 1940. Beginning October 1, 2022 all...
The Union health ministry has released Draft Medical Devices Amendment Rules, 2019 for registration of 36 medical devices based on the Drugs Technical Advisory Board (DTAB) recommendations. These draft rules are made available for objections and suggestions from the stakeholders on or after the expiry...
The rules are published and usually have at least three months for public review and comment before implementation. Even if all the processes function smoothly, it can conceivably take a bill over a year from inception to implementation. Occasionally, after bills have jumped through all the hoops...