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UKRP-services
The UK medical device regulatory system is independent of the European Economic Area (EEA). All medical device manufacturers will need to follow UK laws for (in vitro) medical devices, based on the EU regulations EU-MDR 2017/745 and EU-IVDR 2017/746. All non-UK manufacturers must have a UK-based UK Responsible Person…
BREXIT impact
How medical devices are currently regulated All medical devices are subject to EU legislation, which requires a manufacturer to place a CE mark on their product to attest compliance to applicable standards. Medical devices are regulated under Directive 90/385/EEC on active implantable medical devices (AIMDD), Directive 93/42/EEC on medical devices…
BREXIT and the impact on your business in the EU
The EU Commission issued a 7 page notice on January 10, 2018 titled: ‘Withdrawal of the United Kingdom and EU Rules in the field of industrial products’ This notice clarifies that after March 30th 2019 the UK becomes a Third Country (NON-EU Country). The consequences affecting non-EU manufacturers…
MDR and IVDR finally published (May 4th, 2017)
European Medical Device Regulations 2017/745 (MDR) and In Vitro Diagnostic Regulations 2017/746 (IVDR) are published May 5, 2017 in the Official Journal of the European Union (OJEU), May 4th, 2017. The MDR will replace the Active Implantable Medical Devices Directive (AIMD 90/385/EEC) and the Medical Devices Directive (MDD 93/42/EC), while…
June 2017: MDR and IVDR significant changes
(May 1, 2017) The Medical Device Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR) were initially proposed in 2008 when the EU Commission triggered a consultation on the community’s existing requirements covering medical devices. The plan was 1st released by the commission in 2012 to modify the EU’s medical…
MDR: Changes in the International Clinical Investigations Standard
Many European and IMDRF documents refer to ISO 14155 as a ‘conformity’ standard. So it is an important tool to demonstrate compliance with the EU regulatory requirements. Especially when performing clinical evaluation to demonstrate and provide clinical evidence what is needed and required to support defined medical claim of the…