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The Medical Device Directive—Council Directive 93/42/EEC of 14 June 1993 concerning medical devices—is intended to harmonise the laws relating to medical devices within the European Union. The MD Directive is a 'New Approach' Directive and consequently in order for a manufacturer to legally place a medical device on the European market the ...
The Medicines Control Agency (MCA) and the Medical Devices Agency (MDA) merged in 2003 to form MHRA. In April 2012, the GPRD was rebranded as the Clinical Practice Research Datalink (CPRD). In April 2013, MHRA merged with the National Institute for Biological Standards and Control (NIBSC) and was rebranded, with the MHRA identity being used for ...
Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and placing on the market of medical devices for human use. It repealed Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMDD).
A stringent regulatory authority is a regulatory authority which is: a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before ...
Placing a Medical Device into the European market is contingent upon compliance with the Medical Device Directive (93/42/EEC). While this directive applies in all member states of the European Union, each member state has its own way of implementing the directive within their country, essentially adding regulations to the directive and creating local legislation.
Similar provisions on Post-Market Surveillance are found in the European regulation on in vitro diagnostic medical devices . [ 3 ] [ 4 ] [ 5 ] The MDCG Guideline 2023-3 "Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices" provides further clarification on the topic.
Eucomed was the organisation that represented the interests of the medical device industry in Europe. [1] It represents directly and indirectly 4,500 designers, manufacturers and suppliers of medical technology used in the diagnosis, prevention, treatment and management of disease and disability. [2]
The device was approved with data from a single-arm clinical trial that enrolled thirty people with severe retinitis pigmentosa; the longest follow-up on a trial subject was 38.3 months. [4] People in the trial received the implant in only one eye and tests were conducted with the device switched on, or switched off as a control. [ 5 ]