CE Mark – Technical Files for IVD Medical Devices

The new Regulation 746/2017 of the European Parliament and of the and of the Council of 5 April 2017 on IN VITRO diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU, states in Article 10 "Manufacturers shall draw up and keep up to date technical documentation for those devices. The technical documentation shall be such as to allow the conformity of the device with the requirements of this Regulation to be assessed".

A "manufacturer", based on Article 2 "Definitions" of the new Regulation, "a "manufacturer" means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark”.

Therefore, all manufacturers of in vitro diagnostic medical devices, whether primary (OEM) or secondary (OBL – Private Label Manufacturers), are required to issue, maintain and keep up to date a complete technical file for in vitro diagnostic medical devices.

Attention! There is no longer any differentiation between Primary (OEM) and Secondary Manufacturer (OBL). In the spirit of the new Regulations, the Primary manufacturer is considered a "supplier" of the Secondary, and the Secondary a "customer" of the Primary.

What NOVITAS for you:

• Compilation of the production technical file of an in vitro diagnostic medical device.
• Communication with the primary manufacturer to obtain the information necessary for compiling the technical file
• Communication with the Competent Authority (EOF) or the appropriate Notified Body for the assessment of the technical file and the marking the product with CE.
• Σύνταξη τεχνικού φακέλου λογισμικού κατά IEC 62304 για ιατροτεχνολογικά προϊόντα που ενσωματώνουν λογισμικό (Software as a Medical Device), καλύπτοντας τον πλήρη κύκλο ζωής ανάπτυξης λογισμικού.

*Where IVD = In vitro diagnostics

**Where MD = Medical devices