From 1 January 2021, medical devices must be registered with the MHRA before being placed on the UK market irrespective of whether UKCA marked or CE marked. Please refer to the MHRA timelines for the risk class of your medical device. For Northern Ireland, the EU MDR and IVDR will apply ...
As of 1 January 2021, medical devices in Great Britain are subject to either the UK MDR 2002 (as amended) or the EU MDR (until 30 June 2023) while those in Northern Ireland must be manufactured in accordance with the EU MDR. This paper provides the answers to some key ques...
in the European Commission's EU medical device database EUDAMED under a unique Single Registration Number (SRN): XI-AR-000001836 for the markets of EEA/EU27 & Northern Ireland.Wellkang is also a registered UK Responsible Person (UKRP) in the UK MHRA medical device database for the market ...
Publication by the UK MHRA of new rules forregulating medical devices from 1 January 2021in Great Britain and Northern Ireland. August 2020: Publication ofCommission Implementing Regulation (EU) 2020/1207, containing the common specifications for the reprocessing of single-use devices. ...
Medical Devices In vitro diagnostics United Kingdom Approved Body Notified Body Approved Body Conformity Assessment Body European Union Great Britain Northern Ireland UKCA for Medical Devices and IVDs – FAQs UKRP MHRA EC REP UKCA DoC ER UK(NI) United Kingdom Responsible Person Medicines ...
does not include any of the revisions that would have been made by the EU MDR. It also clarifies how devices will be regulated in Northern Ireland under the NI Protocol and provides that devices placed on the market there will be required to continue to c...
medical devices; pediatrics; 3D printing; diagnostic imaging; delivery device; patient involvement 1. Introduction In the last decade, there has been an exponential rise in the development of medical devices with a concomitant rise in the number of companies working in the life sciences sector. ...
distributed, purchased, used and disposed of within the UK, not including Northern Ireland, were considered. Devices manufactured or supplied from outside of the UK have not been considered, as different legislations apply to lifecycles beyond those in the United Kingdom. The material extraction st...
Making medical devices: Everything you need to know January 2025 edition: Leadership in Medtech featuring Mike Mussallem Medical Design & Outsourcing’s top stories of 2024: Medtronic moves, surgical robots, sterilization and more MedRes expands its Nitinol Technology Center in California ...
The manufacturer is intending to revise the instructions for use of these devices to incorporate the above pre-test checks. 5. ONWARD DISTRIBUTION TO: Please bring this notice to the attention of all who need to know or be aware of it. This will include distribution to: • • • ...