Update: Since 26 May 2021, the MDD Directive 93/42/EEC has been fully replaced by Regulation (EU) 2017/745 (MDR). CE marking of medical devices is now carried out exclusively in accordance with the MDR.

CE Mark for Medical Devices MDD – 93/42/EEC

The new Regulation 745/2017 of the European Parliament and of the Council of 5 April 2017 on medical devices, amends Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and and repeals Council Directives 90/385/EEC and 93/42/EEC.

In Article 10 of the new Regulation "General obligations of manufacturers" the following are stated:

"The manufacturers of devices, other than custom-made devices, 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" according to Article 2 "Definitions" of the new Regulation "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 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 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 a Medical Device production Technical File
• Communication with the primary manufacturer to obtain the necessary information
• 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.

*Where MD = Medical devices