Medical Devices & MDIVD
Medical devices (MD) are health products of which the clinical utility continues to progress and where the positive benefit/risk ratio must be assessed and maintained throughout their entire life cycle.
While waiting for the European regulation project vote, regulations concerning medical devices are still based on the requirements of the following European directives which have been transposed into national laws of all Members States of the EU:
- 90/385/EEC of the Council of 20 June 1990, relating to active implantable MD (AIMD);
- 93/42/EEC of the Council of 14 June 1993, concerning MD;
- 98/79/EC of the European Parliament and of the Council, relating to in vitro diagnosis MD(IVD);
- and subsequent directives.
Nevertheless, Member States keeps some prerogatives such as the organization of materiovigilance, reimbursement and advertising as well as national specificities like DMOS and transparency in France for example.
WHITE-TILLET assists you in the management of your medical devices, pre-or post-market, in the following areas:
24 Rue Gambetta 77400 LAGNY-SUR-MARNE, France