How to check a device’s risk class (RF, HIFU, laser)?

1. Check the declaration of conformity

Legal basis

Medical Device Regulation (MDR) 2017/745 – Art. 19

Every medical device must have:
an EU Declaration of Conformity

✔ What you will find in it:

• the device class: I / IIa / IIb / III
• the intended purpose (medical vs aesthetic)
• the manufacturer’s details

This is the most important document for the buyer

2. CE marking + notified body number

Art. 20 MDR

The device should bear:

• the conformity mark CE
• (for higher classes) the notified body number, e.g. CE 0123

✔ Interpretation:

• CE without a number → usually class I
• CE + number → class IIa, IIb, III

The higher the class → the higher the risk

3. Instructions for use

Annex I MDR

The manufacturer must specify:

• indications
• contraindications
• risks
• possible complications

✔ What to look out for:

• whether burns / tissue damage are described
• whether the device acts at depth
• whether it requires special training

4. Classification under the MDR (Annex VIII)

The buyer can ask:

“Under which MDR rule was the device classified?”

Most commonly for aesthetics:

• Rule 9 → energy-based devices

5. Checking the intended purpose is crucial!

Is the device intended:

• for treatment (medical)
• to improve appearance (aesthetic)

✔ Why this matters:

• it affects the risk class
• it affects VAT
• it affects how the device is used

6. The EUDAMED database (EU)

Art. 29 MDR

the official EU database of devices (still being partially implemented)

You can check:

• the manufacturer
• the class
• the certification

7. Notified body certificate

For class IIa and higher:

the manufacturer MUST hold a certificate from a notified body

✔ What to check:

• the name of the body
• the number
• the validity

The most common mistakes buyers make

❌ “It has CE marking, so it’s safe”
👉 CE ≠ no risk

❌ “It’s medical, so it’s better”
👉 that depends on its intended purpose

❌ “Anyone can use it”
👉 the MDR does not regulate this

Practical interpretation for aesthetics

The 3 most important questions to ask the seller

The buyer should always ask:

1. What is the device’s MDR class?
2. What is its intended purpose (medical vs aesthetic)?
3. Under which MDR rule was it classified?

“A buyer can check a device’s level of risk on the basis of its MDR class, declaration of conformity and CE marking – however, CE marking alone does not mean low risk, only that safety requirements have been met.”