Blood pressure monitors, thermometers and home diagnostics

• Regulation (EU) 2017/745 — Medical Devices
• Regulation (EU) 2017/746 — In Vitro Diagnostics for tests
• Directive 2014/53/EU where connected
• Regulation (EU) 2016/679 for the app and cloud

Who has to appoint one

Manufacturers outside the Union placing home health measurement devices on the EU market. Blood pressure monitors, thermometers and oximeters are medical devices; self-tests for infections, fertility or cholesterol are in-vitro diagnostics with their own regime and, for self-testing, higher classification.

Thresholds and exemptions

None. Consumer packaging and low price do not change the classification, and self-test IVDs are generally Class C or B requiring notified body involvement.

What must appear on the label

CE marking with the notified body number, manufacturer and EC REP details, UDI and Basic UDI-DI, lot or serial number, the measurement range and accuracy, and instructions for use including when to consult a doctor.

Marketplace fields

Marketplaces require EUDAMED registration and the EC REP details, and remove devices making diagnostic claims without them. Oximeters attracted extensive enforcement after 2020, including on accuracy across skin tones.

Documentation you must hold

Technical documentation under Annex II and III, clinical evaluation or performance evaluation for IVDs, risk management file, post-market surveillance plan, EUDAMED registration and the authorised representative mandate.

Standards and testing

IEC 80601-2-30 for automated blood pressure monitors, ISO 80601-2-56 for clinical thermometers, ISO 80601-2-61 for pulse oximeters, and for IVDs analytical and clinical performance studies including usability studies for lay users.

Language requirements

Instructions for use and result interpretation in the language of each member state, which for self-tests is critical because misreading a result is a foreseeable harm.

When it applies

Certification and registration before placing on the market. IVDR transitional deadlines run to 2027 and 2028 by class for devices already on the market under the old Directive.

How long records are kept

Ten years under the MDR and IVDR.

What happens if you do not comply

Withdrawal, prohibition of sale, and joint liability of the authorised representative for defective devices. Inaccurate consumer diagnostics attract both device enforcement and consumer protection action.

Who enforces it

Medical device competent authorities, notified bodies, market surveillance and data protection authorities for connected models.

Where the boundary lies

A wellness step counter is a consumer product; a device that measures a physiological parameter for a medical purpose is a device. Connected models add a GDPR representative obligation because health data of EU users reaches the vendor's cloud.

Questions we are asked

Is a smart thermometer a medical device?

If it measures body temperature for a medical purpose, yes, and the connectivity adds the radio and data protection regimes on top.

Are home test kits devices?

They are in-vitro diagnostics under the IVDR, and self-tests are classified higher precisely because a lay person interprets the result.