How can small businesses get their medical devices approved in the EU?

If you’re a small business or startup looking to sell a medical device in the European Union, you might feel overwhelmed by all the regulations and paperwork. Don’t worry—you’re not alone! While the EU has strict rules for medical devices, they’re there to ensure safety and quality. The good news? With the right approach, even small companies can complete the process successfully. Let’s break it down step by step.

Step 1: figure out if your product is a medical device

Not every product used in healthcare is considered a "medical device" under EU rules. The Medical Device Regulation (MDR 2017/745) defines a medical device as anything used for diagnosis, prevention, monitoring, or treatment of diseases, injuries, or disabilities.

Examples of medical devices: Syringes, bandages, pacemakers, dental implants, and even some mobile health apps.

Not medical devices: General wellness products, like fitness trackers that don’t diagnose or treat anything.

If you're unsure, check Annex XVI of the MDR or consult an expert.

Step 2: determine your device’s risk class

The EU classifies medical devices into four risk categories:

• Class I – Low risk (e.g., reusable surgical instruments, bandages)
• Class IIa – Medium risk (e.g., hearing aids, dental fillings)
• Class IIb – Higher risk (e.g., infusion pumps, ventilators)
• Class III – Highest risk (e.g., heart valves, implantable pacemakers)

Why does this matter? The higher the risk, the more strict the approval process.

Step 3: choose a Notified Body (If Required)

If your medical device falls under Class Is (sterile), Im (measuring), IIa, IIb, or III, you will need to work with a Notified Body (NB). These independent organizations assess whether your product meets MDR/IVDR requirements.

To choose the right Notified Body:

• Check the NANDO database for designated Notified Bodies.
• Compare fees, turnaround times, and expertise in your specific device category.
• Ensure the NB is designated for your device type under MDR or IVDR.

Once selected, you will submit your technical documentation for review.

Step 4: undergo conformity assessment

Your chosen conformity assessment route depends on your device classification.

• Class I (non-sterile, non-measuring): Self-certification, no Notified Body needed.
• Class Is, Im, IIa, IIb, III: Requires NB review of technical documentation and QMS.

For higher-risk devices, an on-site audit of your QMS (ISO 13485 compliance) is required. Once the Notified Body confirms compliance, they issue a CE Certificate.

Step 5: CE Marking and Declaration of Conformity

Once all assessments are successfully completed, you can affix the CE Mark to your product.

Final steps include:

• Drafting and signing a Declaration of Conformity.
• Ensuring all labeling and Instructions for Use (IFU) comply with MDR requirements.
• Registering your device in the EUDAMED database.

Congratulations! Your medical device is now ready for the EU market.

Step 6: work with a Notified Body

For most medical devices (except Class I non-sterile, non-measuring devices), you’ll need a Notified Body (NB) to assess your device’s compliance with MDR requirements.

What to do:

• Find an appropriate Notified Body designated for your device type.
• Submit your technical documentation for review.
• Prepare for audits of your Quality Management System.

Once your device successfully passes the conformity assessment, the Notified Body will issue a CE Certificate.

Step 7: register your device in EUDAMED

Once your device has been assessed and approved, it must be registered in the European Database on Medical Devices (EUDAMED). This ensures transparency and traceability within the EU market.

What to do:

• Obtain a Single Registration Number (SRN) through your national Competent Authority.
• Enter all relevant device details into EUDAMED.
• Ensure post-market surveillance data is updated regularly.

This step is crucial for maintaining compliance and allowing EU regulators to monitor device safety.

Step 8: market your device and ensure ongoing compliance

Congratulations! With CE marking and registration complete, you are now ready to sell your medical device in the EU. However, compliance does not stop here.

Ongoing responsibilities:

• Implement a Post-Market Surveillance (PMS) system to track device performance.
• Report serious incidents and field safety corrective actions as part of Vigilance Reporting.
• Regularly update your technical documentation and conduct periodic audits.

Staying compliant will ensure continued access to the EU market and help maintain customer trust.

Final thoughts: is it difficult for small businesses?

Getting a medical device approved in the EU as a small business or startup may seem like an overwhelming task, but it is entirely achievable with the right approach. While larger manufacturers have dedicated regulatory teams, small businesses can navigate the process effectively by leveraging external support, careful planning, and understanding key regulatory requirements.

The EU’s Medical Device Regulation (MDR) has introduced stricter compliance requirements, but these rules apply to all manufacturers equally—big or small. By taking a structured approach, prioritizing quality management, and engaging with experts when needed, small businesses can successfully bring their medical devices to market.

Persistence, preparation, and regulatory awareness are the keys to success!