Regulation on Medical Devices MDR 745/2017

On 5 April 2017 the EU. approved the new Regulation on medical devices, replacing the two existing directives, the Medical Devices Directive MDD 93/42 and the directive on active implantable medical devices AIMD 90/385. The new Regulation has applied since 26 May 2021. With Regulation (EU) 2023/607, the transition period for existing products (legacy devices) has been extended until 31 December 2027 for higher-risk products and until 31 December 2028 for lower-risk products.

Key changes:

The aim of the new Regulation is to address certain inherent weaknesses in the old directives, as well as the rapid development of science and technology in the field of Medical Devices. To this end, it introduces certain improvements, the most important of which are set out below:

the retention of a Technical File for every medical device manufactured by secondary manufacturers (private label products).
stricter ex-ante control for high-risk devices through a new control mechanism before the market, with the involvement of a pool of experts at EU level
is strengthening of the criteria for the designation and the and of the procedures for the oversight of Notified Bodies.
the inclusion of certain aesthetic devices that present the same characteristics and the same risk profile as the corresponding medical devices falling within the scope of the present Regulations .
improvement of transparency through the creation of a comprehensive EU database for medical devices and of a traceability system at device level.
the introduction of the "Implant Card", containing information about implanted medical devices for a patient.
the strengthening of the rules on clinical evidence, including an EU-level coordinated procedure for the authorisation of multi-centre clinical investigations.
is strengthening of the surveillance requirements post-market for manufacturers.
improved coordination mechanisms between EU countries in the fields of vigilance and market surveillance.

The affected businesses (manufacturers and others) must ensure their products' compliance with the new Regulation within the above transition periods.

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

What NOVITAS for you:

The personnel of NOVITAS have extensive experience and expertise in the field of medical devices and and related services and are in a position to support your company with the following:

Assessment of the completeness of the production technical file of a medical and in vitro diagnostic device.
Revision of an existing medical device production technical file.
Compilation of a medical device production technical file.
Communication with the Notified Body for marking the product with CE.

*Where medical devices = MD

EUDAMED & EOF Registration Services – Technical Documentation

1. EUDAMED Registration for Manufacturers, Importers and European Authorised Representatives

We fully manage the actor registration process in the European EUDAMED database, as required by Regulations MDR 2017/745 and IVDR 2017/746 — for manufacturers, importers and authorised representatives (EC REP) — through to obtaining the Single Registration Number (SRN).

2. Registration of Medical Devices in EUDAMED

We register your medical devices in EUDAMED (UDI/Devices module), with correct assignment of Basic UDI-DI and UDI-DI and complete submission of all required data, so that your devices can be legally placed on the European market.

3. EOF Registration for Manufacturers and Distributors

We support the registration of manufacturers and distributors of medical devices with EOF (the Greek competent authority), preparing and submitting all required documentation.

4. Registration of Medical Devices with EOF (Gremdis database)

We handle the registration of your devices in EOF's Gremdis database, with proper documentation and classification for full compliance with national requirements.

5. Guidance on Technical File Preparation for Medical Devices and Software (MDSW)

We provide specialised guidance on preparing the technical file for medical devices and medical device software (MDSW), in line with the requirements of MDR 2017/745 and the relevant harmonised standards (e.g. IEC 62304).

6. Technical File Development for European Health Data Space (EHDS) Software

We develop software technical documentation in accordance with the requirements of the European Health Data Space (EHDS) Regulation, for EHR systems and health applications falling under the new framework.

7. Preparation and Submission of the Manufacturer Incident Report (MIR)

In the event of adverse incidents, we prepare and submit the Manufacturer Incident Report (MIR) to the competent authorities, as part of the vigilance obligations under MDR 2017/745.

For more information, please do not hesitate to contact us: