Do I need a notified body for my medical device?

If you’re planning to sell a medical device in the European Union (EU), one of the first questions you’ll encounter is whether you need a Notified Body (NB) to assess and certify your product. Notified Bodies are independent organizations designated by EU authorities to evaluate whether a medical device complies with the Medical Device Regulation (MDR 2017/745) or the In Vitro Diagnostic Regulation (IVDR 2017/746).

But do you really need one? The answer depends on your device’s classification and risk level. Some manufacturers can self-certify, while others require a thorough third-party assessment. Let’s break it down.

When you DON’T need a Notified Body

If your device falls into the lowest-risk category, you may be able to self-certify, meaning you don’t need a Notified Body to assess compliance before placing your product on the market.

This applies to:

• Class I (Non-sterile, Non-measuring) Medical Devices – Examples include basic bandages, manual wheelchairs, and reusable surgical instruments.
• Class A In Vitro Diagnostic Devices (IVDs) – If the IVD poses minimal risk to patients and users (e.g., laboratory reagents with no direct patient contact), manufacturers can self-declare conformity.
• Class IIb – Higher risk (e.g., infusion pumps, ventilators)
• Class III – Highest risk (e.g., heart valves, implantable pacemakers)

Self-certification means you still need to follow all MDR or IVDR requirements, such as preparing technical documentation, implementing a quality management system, and ensuring post-market surveillance. However, you won’t need an external audit from a Notified Body.

When you DO need a Notified Body

For most medical devices and IVDs, an independent third-party assessment is required before you can affix the CE Mark and legally sell in the EU.

You must work with a Notified Body if your device falls into one of the following categories:

• Class I Sterile (Is) or Measuring (Im) Devices – For example, sterile wound dressings or thermometers require Notified Body involvement due to their additional risks.
• Class IIa and IIb Devices – These include items like dental fillings (IIa) and infusion pumps (IIb), which involve moderate to high risks requiring Notified Body assessment of technical documentation and quality management systems.
• Class III Devices – The highest-risk category, including implantable devices like pacemakers or heart valves. These undergo the strictest scrutiny, including clinical evaluation, before certification.
• Most In Vitro Diagnostic Devices (IVDs) – If your product falls into Class B, C, or D, you will need an NB to verify compliance, as these devices can impact patient health outcomes directly (e.g., HIV tests, blood glucose monitors, genetic testing kits).

Choosing and working with a Notified Body

If your device requires Notified Body involvement, you’ll need to select an accredited organization designated for your device type. Not all NBs are authorized for every category, so it’s crucial to check their designation scope in the NANDO database.

Once you choose an NB, the process typically involves:

1. Submitting your technical documentation – The NB reviews your device’s safety, performance, and compliance with MDR/IVDR.
2. Undergoing audits (if applicable) – If your device is medium to high-risk, your manufacturing site may be inspected for quality management compliance (ISO 13485).
3. Receiving certification – If approved, you receive a CE Certificate, allowing you to legally sell your device in the EU.

Conclusion

Not all medical devices require a Notified Body, but if your product falls into anything beyond Class I (non-sterile, non-measuring) or low-risk IVDs, third-party assessment is necessary. Understanding your device classification is key to determining whether you can self-certify or need NB approval.

If in doubt, consult a regulatory expert early in your process. This can save time, money, and ensure a smooth path to EU market approval.