Obligations of Manufacturers of Medical Devices and IVD Medical Devices

The new Regulations 745/2017 of the of the European Parliament and of the and of the Council of 5 April 2017 on on medical devices, and 746/2017 of the European Parliament and of the Council of 5 April 2017 on IN VITRO diagnostic medical devices, in Article 10 "General obligations of manufacturers" provide, among other things, that:

Manufacturers of devices shall draw up and keep up to date technical documentation for those devices (medical devices and in vitro diagnostics). The technical documentation shall be such as to allow the conformity of the device with the requirements of these Regulations to be assessed.
Manufacturers shall establish, document, implement and maintain a risk management system.
Manufacturers shall perform a clinical evaluation.
Where compliance with the applicable requirements has been demonstrated by the applicable conformity assessment procedure, manufacturers of devices, other than custom-made or investigational devices, shall draw up an declaration of conformity EU
Manufacturers shall comply with the relevant registration obligations for their products.
Manufacturers shall ensure that procedures are in place to keep series production in conformity with the requirements of this Regulation . Manufacturers of devices, other than investigational devices medical devices, shall establish, document, implement, maintain, keep up to date and continually improve a quality management system that shall ensure compliance with this Regulation in the most effective manner and in a manner that is proportionate to the risk class and the type of device. The quality management system shall cover all parts and elements of a manufacturer's organisation dealing with the quality of processes, procedures and devices. It shall govern the structure, responsibilities, procedures, processes and management resources required to implement the principles and actions necessary to achieve compliance with the provisions of this Regulation.
Manufacturers of devices shall implement and keep up to date the post-market surveillance system.

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 and of an in vitro diagnostic medical device.
Communication with the Competent Authority (EOF) or the appropriate Notified Body for the assessment of the technical file and the CE marking of the product.
Preparation of risk analyses (RM/RA) for the production of a medical device and an in vitro diagnostic medical device based on the applicable international and harmonised standards and Regulations.
Preparation of literature-based clinical evaluations (CLR).
Drafting of product Declarations of Conformity (DoC).
Development, installation and implementation of a new or or adaptation of an existing ISO 13485 quality management system for the entire production chain of the medical device or the in vitro diagnostic medical device.
Development of a surveillance system (PMS) and and recall system (RMS) following the placing of the medical device or the in vitro diagnostic medical device on the market.