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Illustration MedTech start-ups: where to begin preparing for CE marking?

MedTech start-ups: where to begin preparing for CE marking?

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1. Why structure your approach from the outset?

Preparing for CE marking is not an administrative formality at the end of the process, but a process that begins with the very first design ideas. Structuring your approach from the outset will

  • save time and avoid costly iterations in the pre-clinical or clinical phases,
  • secure your technical and clinical choices,
  • maximize your chances of attracting investors and partners,
  • build a robust technical file, accepted by a notified body.



2. Understanding the regulatory basis

CE marking for medical devices is governed by Regulation (EU) 2017/745 (MDR). It requires, from the earliest stages of development:

  • a risk analysis in accordance with ISO 14971,
  • a demonstration of compliance with general safety and performance requirements (Annex I of the MDR),
  • justification of fitness for use (ISO 62366),
  • rigorous clinical evaluation,
  • the creation of a technical file (appendices II and III of the MDR),
  • and the implementation of an ISO 13485-compliant quality management system (QMS).



3. Key steps to be taken upstream

Here are the milestones that every MedTech start-up should aim for right from the early development phase:


a) Clarify product use

  • Destination and intended use
  • Check that the product is indeed a medical device (article 2.1 of the MDR)
  • Classification according to Annex VIII of the MDR


b) Frame regulatory development

  • Define a regulatory development plan: milestones, deliverables, resources
  • Identify applicable harmonized standards (Commission list)
  • Anticipate requirements for fitness for use, biocompatibility, cybersafety, etc.


c) Lay the documentary foundations

  • Start up a lean QMS that complies with ISO 13485: document control, risk management, purchasing management, design (7.3)
  • Select appropriate management tools: eQMS, traceable database, etc.


d) Lay the foundations of the technical file

  • Draft the first versions of :
    • device description,
    • risk analysis (preliminary),
    • clinical development plan (PMCF if applicable),
    • compliance demonstration strategy.



4. Examples of effective approaches

  • Startup A (connected device): integrated IEC 62304 requirements for the software from the outset, avoiding redesign of the software architecture prior to CE evaluation.
  • Startup B (implantable device): structured its risks according to ISO 14971 + FMEA, facilitating validation by the notified body from the very first submission.
  • Startup C (class I): used a "lean ISO 13485" approach to demonstrate sufficient conformity without burdening its operations.



5. Mini FAQ

Is it necessary to have a notified body right from the start?

No, but it is important to identify those competent for your class and product typology, as their deadlines and expectations may condition your strategy.


Is it possible to outsource the entire QMS?

Outsourcing is possible, but you' ll need to demonstrate that the manufacturer is in control. Key procedures must be understood and validated internally.


How long will it take?

Between 12 and 36 months, depending on the class of DM, the level of innovation, clinical requirements and the maturity of the start-up.



6. And now, what to do concretely?

Here's a checklist of the first steps to take:

  • Validate that the product falls within the definition of a DM (MDR art. 2)
  • Define destination andintended use
  • Classify the DM according to Annex VIII
  • Draw up an initial ISO 14971 risk analysis
  • Start an ISO 13485 documentation system
  • Map applicable technical standards
  • Lay the foundations of the technical file
  • Assess preclinical testing/validation needs
  • Choose an experienced regulatory partner (anyone in particular??)



7. Conclusion

CE marking can't be improvised, but it can be prepared pragmatically, without losing sight of business, clinical and industrial issues. The earlier you structure your approach, the greater your chances of success, financing and market access.


At CSDmed, we support MedTech start-ups from the R&D phase through to CE or FDA approval, with a tailored, realistic and results-oriented approach.


Contact us to lay the foundations of your regulatory strategy and save time in getting your product to market.