Technical files and Procedures for CE Marking
The CE marking of your product is the legal manufacturer’s responsibility (according to the directives).
The CE mark guarantees that the medical device complies with all the regulatory requirements that apply.
However, in order to have the right to put the CE mark, the legal manufacturer has to establish a technical file and comply with the CE marking procedure in regards to the class of the device.
WHITE-TILLET advises and assists you in:
- Implementing, updating, upgrading of technical files (STED or European regulation format);
- The strategy and the CE marking process;
- The realization of the post-market surveillance file including post-market clinical data and risk management files;
- Relations with the Competent Authorities and Notified Bodies;
- The preparation of dossiers for the USA and their presentation to the FDA via our international network;
- The preparation of the file ‘active substance’ of the technical dossier for combination products
- Diagnostic test files (IVD) or companion tests of medicinal products.
Tillet Y. Drug/Device Combinations : a Promising Future. AMIPS Info 4ème Trim 2005 et 1er Trim 2006;72:74-77.
Tillet Y., Lewellen O., Perroy AC. When does healthcare stand-alone software become a medical device ? TOPRA Regulatory Rapporteur; 10 (1) January 2013:21-25.
Maillols-Perroy A.C. et Tillet Y. Legal issues in pharmaceutical digital communication in the EU. Regulatory Focus. RAPS Part 1, 2,3 ;April, May, June 2013.
Tillet Y et Elia-Foeillet S. Voyage dans le monde des dispositifs médicaux. La Gazette Juillet 2013 ;80 :4-10.
Dubos C., Rath-Lavialle A., Tillet Y. How to set up and manage a 510(k) process? RIS.World; White-Paper October 2015.
Tillet Y, Breysse A, Dreyfuss T, Dubos C, Lewellen O, Rath-Lavialle A, Tillet A, Yang M, Zerial A. Precision medicines and pharmacogenomic testing: from scientific basis to assessment, regulatory framework, labelling, and practical information. Gazette de l’AFAR, 2016. In press.
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