CE marking

For your medical devices

Certification of your medical devices

For a medical device to be placed on the European market, it must be CE marked (European conformity). To do this, your product must comply with defined regulatory requirements, not only in terms of health and safety, but also in terms of performance and environmental protection. Our team can help you put together the technical file you need to obtain CE marking for your medical and healthcare devices.

The standard for marketing in Europe is Regulation (EU) 2017/745. Regulation (EU)2023/607 was published on March 20, 2023, and extends the transition periods set out in the Medical Devices Regulation. Depending on the risk class, the deadline is either December 31, 2027 or December 31, 2028.

The life cycle of a medical product

The certification of a medical device involves working on the expected requirements throughout its development. From the feasibility phase onwards, understanding users needs, clinical and regulatory requirements can give your company the competitive edge needed to bring your product to market.

We can help you right from the start of your medical device project, not only to determine whether your product is indeed a medical device, but also to analyze its initial risks and assess your humain resource requirements. We can also support you in the planning, development and manufacture of your product, for example, in the design of a prototype based on both customer needs and technical requirements. Once your device has been validated and launched on the market, we can also support you in post-marketing surveillance, for comprehensive monitoring throughout the life of your product.

Our support for CE marking of your medical products

Because obtaining CE marking can be a complex and time-consuming process, Cisteo is here to help you. Our mastery of the applicable regulations and the competitive environment will help you ensure that your product development meets all regulatory requirements. Our support service for drafting technical documentation in compliance with Regulation (EU) 2017/745 can include different elements depending on your needs, whether you're a start-up in the midst of developing your medical device or a manufacturer needing to outsource part of the process :

Classification of your DM (risk class, EMDN code, MDS/MDN/MDT/MDA code)
Choose your Notified Body
Responses to general safety and performance requirements
Clinical evaluation file
Literature review (State of the art)
Fitness for use file
Biological risk assessment
Toxicological risk analysis (excluding laboratory analysis costs)
Map of PMCF
Plan de PMS

CE Marking training courses

To help you register your medical device, our company advises and trains you in assessing your product's conformity, compiling technical documentation, writing the technical file, etc.

They trust us

Lauriane has guided us through the classification of our system, providing in-depth thought, enabling us to define the appropriate regulatory compliance path and the corresponding steps. She provides answers to each of our requests. Her approach is pragmatic, concrete and tailored to our needs.

G. Haiat, PhD, CSO WaveImplant

Lisa's support enabled us to identify the gaps in our technical documentation.

It was a real added value. She brought us her expertise, a thorough and precise grasp of the subject. She also brought simplicity to the regulatory difficulties.

This support was essential for us. It helped us understand the logic behind it, and now we'll be able to duplicate, and thanks to the hotline, we can contact Lisa again at any time.

Stéphanie Hudeley, Project Manager, Benoit Systèmes

Regulatory strategy, compiling your technical documentation

We provide you with concrete answers. Let's talk about your project!