Regulatory AffairsMedical Devices
On 5 April 2017, the EU issued Regulation 745/2017 laying down the obligations on Medical Devices and manufacturers, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.
On 5 April 2017, the EU issued Regulation 746/2017 laying down the obligations on In Vitro Diagnostic Medical Devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
Complete Solutions
We offer complete solutions in:
- Preparation, update and gap Analysis of Medical Device technical documentation (technical file).
- Support with current EU and local legislation requirements on medical devices.
- Notification of Medical Devices with the Local Competent Health Authorities.
- Direct communication with the Local Competent Health Authorities for the evaluation of the technical file and CE Marking.
Full Support
Through our experienced network of partners we can support you with:
- Communication with Notified Bodies for CE marking.
- Development and execution of risk analysis/management and clinical investigation studies though established laboratories.
- Declaration of Conformity and Conformity Assessment.
- Development, implementation and adjustment of ISO 13485 requirements on medical devices.
- Development of post-market surveillance system and recall procedures in communication with the Local Competent Health Authorities.