Search results
Results from the WOW.Com Content Network
An authorised representative may also carry out a conformity assessment of a medical device on behalf of the manufacturer. [7] European ‘Blue Guide" [8] describes that delegation of an authorised representative should be set out in writing (as an agreement, mandate, or power of attorney) to define contents and limits of tasks. The copy of the ...
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.
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 It repealed Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMDD).
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 ...
Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency (EMEA). [ 4 ] [ 5 ] The EMA contributed to the Global Vaccine Action Plan developed by the Decade of Vaccines Collaboration, endorsed by the 194 Member States of the World Health Assembly in May 2012, and published ...
At the same time the NB-MED (European Forum of Notified Bodies Medical Devices) coordination revised their code of conduct due to criticism. [ 7 ] [ 15 ] In late 2013 and early 2014, a French court ordered (and later upheld its decision) that notified body TÜV Rheinland pay restitution to those affected by the PIP scandal. [ 16 ]
Get AOL Mail for FREE! Manage your email like never before with travel, photo & document views. Personalize your inbox with themes & tabs. You've Got Mail!
Regulation (EU) 2017/746 (IVDR) is a regulation of the European Union on the placing on the market and putting into service of in vitro diagnostic medical devices (IVD), repealing Directive 98/79/EC (IVDD), which also concerned IVD. The regulation was published in April 2017 and is closely aligned to the EU regulation on medical devices.