Why CE Certification Matters for Startups
CE marking is not just a regulatory requirement — it’s the passport to the EU market. Without it, medical devices cannot be legally sold in Europe. For startups, achieving CE certification also builds trust with investors, healthcare providers, and global partners.
Step 1: Identify the Applicable Regulation
- Check whether your product falls under MDR (EU 2017/745) or IVDR (EU 2017/746).
- Misclassification at this stage can lead to delays and extra costs.
Step 2: Classify Your Device
- Devices are categorized into Class I, IIa, IIb, or III based on risk.
- Higher-risk devices require stricter evaluations and notified body involvement.
Step 3: Build a Quality Management System (QMS)
- Most startups adopt ISO 13485 as their framework.
- Even small teams must establish documented procedures for design, manufacturing, and post-market activities.
Step 4: Prepare Technical Documentation
Your technical file must include:
- Device description & intended use.
- Risk management documents (ISO 14971).
- Clinical evaluation data.
- Instructions for use and labeling.
Step 5: Engage a Notified Body (If Required)
- For higher-risk devices, a Notified Body must review and approve documentation.
- Startups should engage early, as capacity is often limited.
Step 6: Register in EUDAMED
- Upload your device data to the EUDAMED database.
- Assign a Unique Device Identification (UDI) code.
Step 7: Affix the CE Mark
- Once approval is granted, place the CE mark on your device, packaging, and manuals.
- This confirms compliance across the EU.
Tips for Startups
- Plan Early: CE certification can take 12–18 months — factor this into your roadmap.
- Leverage Consultants: External experts can speed up the process and reduce mistakes.
- Budget Wisely: Certification costs can be high — allocate resources from the start.
- Stay Agile: Unlike big corporations, startups can often adapt processes faster.
Conclusion
For startups, CE certification may seem like a mountain to climb, but with the right preparation, it becomes a clear and achievable path.
By following these steps, medical device startups not only gain access to the EU market but also prove to investors and customers that they are serious about safety, compliance, and long-term success.
