Your product is a DM or an IVDD if it meets the definition stated in the new European regulations (EU) MDR 2017/745 or (EU) IVDR 2017/746.

To find out more, please consult these articles on the different classes of medical devices: different DM classes and IVDD classes.

European regulations on MDs and IVDDs were significantly modified in 2017 with the publication of two new European regulations that currently regulate medical device compliance requirements for market access, as follows:

• For MDs: Download the MDR - Medical Device Regulation EU) 2017/745 (MDR)
• For IVDDs: The European Union In Vitro Diagnostics Regulation (EU) 2017/746 (IVDR)

For Class I medical devices, CE marking is obtained on the basis of a self-declaration submitted by the manufacturer.
For medical devices belonging to other classes (IIa, IIb, III), the procedure for obtaining CE marking is more restrictive, requiring 3 key elements to be implemented.

It is the manufacturer's responsibility to follow European regulations and implement 3 elements:

• A Quality Management System
  (QMS - ISO13485 compliant) within the company initiating the project;

• Technical Documentation complying with applicable European
  European regulations to manage product risks;

• Selection of a clinical evaluation protocol to attest to the device's performance, safety and clinical benefit relative to human variability.

Other applicable standards will also need to be considered, depending on the characteristics of your product, such as ISO13485, ISO14155; ISO 14971 and IEC62304, etc.

To find out more, read this article on the different classes of medical devices.

On average, it takes 18 months (from contractual agreement with the Notified Body to delivery of the CE certificate of conformity), depending on the characteristics of your medical device and the regulatory requirements involved. Depending on the nature of your product, these delays may vary.

These delays are directly linked to the time needed to design and produce the documents required to submit your product's conformity file, and to the availability of notified bodies.

To find out more, please consult this article on CE marking.

The best thing to do is to start your regulatory procedures as early as possible in the research and development phase of your product. This enables you to anticipate and manage the risks associated with the use of your innovation at an early stage, and to embrace the principles of continual improvement.

We support projects at different stages of maturity, whether you're in the research, development, deployment or marketing phase. At each stage, there are regulatory must-dos for which you can consult us. We'll work with you to plan what you need to put in place according to your state of progress.

To find out more, read this article on the regulatory process for a medical device..

We support companies in accessing the European and US FDA markets (CE marking, 510K procedure, PMA, ....).

Regardless of your geographical location, our team can provide you with a personalized and local support.

We have all the necessary resources to collaborate remotely, and can also travel (on a case-by-case basis) to meet you.

Our multi-disciplinary team is driven by business experts accredited by BPI France for the “Diagnostic DM” program. (a scheme to help DM manufacturers finance the regulatory process).

Backed by a highly-specialized medical ecosystem, it supports innovative projects in all aspects of market access strategy, quality, regulatory and clinical affairs, and is approved for the Research Tax Credit.

We have a market access strategy unit, a QARA unit, a clinical unit and a digital health unit, all working together to provide a 360° vision of your innovation. The team is made up of senior QARAs with over 10 years' experience in quality and regulatory affairs (with registrations in around 40 different countries), as well as QARA engineers with experience of different types of medical devices (hardware, software), PhD profiles, particularly for subjects linked to clinical research, profiles with dual QARA and clinical skills, experts in digital health and artificial intelligence...

Your preferred contacts will be selected in real time to offer you the right expertise for your needs.

To contact us: contact@rumb.fr. or via the contact form on our website.