Requirements map
Medical device testing: what your product actually needs
Medical device testing splits into thirteen laboratory categories, and which ones apply to you is decided by a handful of facts about your product: whether it is powered, whether it has a radio, what it touches and for how long, and whether it ships sterile. Pick your product below and each category is stated as a condition, cited to its source, and ends at the laboratories in our register that hold the standard.
This is a map of what testing a product class commonly needs. It is not regulatory advice, and it does not replace your own risk analysis or a notified body's view.
The product family
6 of 15 mapped
This map is built product by product, and the family it works from has 15 product types. The first version maps 5 of them in full, plus medical device software, where the honest answer is that most of what it needs is not laboratory testing. The remaining 9 are listed here rather than left out, so you can see what this version covers instead of guessing at it.
- Wearable ECG patch monitorAn adhesive single-patient patch that records the heart's electrical activity (an electrocardiogram, or ECG) for days at a time.Covers 9 categories
- Ambulatory ECG recorder with electrodesA body-worn recorder plus disposable electrodes, fitted by a clinician and worn for a day or two. Often called a Holter recorder.Map in preparation
- Fingertip pulse oximeterA clip-on meter that reads blood oxygen saturation (SpO2) and pulse rate through the fingertip, often sold for home use.Covers 6 categories
- Bedside patient monitorA mains-powered clinical monitor combining ECG, SpO2, blood pressure and temperature, with alarms.Covers 8 categories
- Blood pressure monitorAn automated upper-arm oscillometric device sold to consumers.Covers 5 categories
- Volumetric infusion pumpA mains-powered clinical pump that delivers fluid to a patient through a disposable tubing set.Map in preparation
- Insulin pump, worn or patchA body-worn battery pump whose infusion set puts a fine tube under the skin, used unsupervised at home.Map in preparation
- Continuous glucose monitoring systemA skin-inserted sensor plus a wireless transmitter and a phone or receiver app.Covers 7 categories
- Medical device softwareSoftware that is itself the medical product: an app, a program or a cloud service, with no hardware of its own. The industry calls this software as a medical device.Mostly not laboratory testing. This page says so plainly and shows what is left.Covers 2 categories
- Automated external defibrillatorA defibrillator an untrained bystander can use, with a high-energy output and a battery that has to sit ready for years.Map in preparation
- Sterile single-use intravenous setDisposable tubing supplied sterile, sitting directly in the fluid and blood path.Map in preparation
- Reusable stainless surgical instrumentA non-powered instrument that the hospital cleans and steam sterilizes between cases.Map in preparation
- Advanced wound dressingAn adhesive or absorbent dressing supplied sterile, in prolonged contact with a wound.Map in preparation
- Electrosurgical unitA mains-powered generator that delivers high-frequency energy to tissue through an active electrode.Map in preparation
- Clinical electronic thermometerA handheld battery thermometer for oral, underarm or ear use, sold for the home.Map in preparation
The rows marked in preparation are waiting on a real answer rather than on time. Most of them are sterile products, where our register coverage is still thin enough that a map would end at two laboratories, and one of them turns on a battery question our own validation record has not settled. We would rather show you the gap than fill it with a guess.
How to read these pages
Every card states a condition first, never a verdict. Where our evidence is strong the card says a category may require testing; where it is good but less certain it says the category commonly involves it. Nothing on these pages declares a standard mandatory for your product, because that judgement is yours and your notified body's.
Plain words first
- MDR:
- the EU Medical Device Regulation, the law a medical device must satisfy to be sold in the EU.
- RED:
- the EU Radio Equipment Directive, the law that applies on top of the MDR as soon as your product contains a radio such as Bluetooth or Wi-Fi.
- Harmonised:
- a standard named on the EU's official list. Testing to it earns presumption of conformity, meaning the authorities accept it as proof without further argument.
- Accredited scope:
- the exact list of tests a laboratory has been independently assessed to perform, published by its national accreditation body.
Harmonised means EU regulators officially recognise this standard under the MDR: test to it, and that requirement is presumed met. Not harmonised does not mean the standard is wrong or unneeded. It only means that automatic recognition does not apply, so the testing still counts as evidence, without the shortcut. Under the RED the same logic applies with one difference worth knowing: a gap against Article 3(1) does not block self-declaration, while deviating from EN 300 328 or EN 301 893 triggers EU-type examination by a notified body.
Every standard shows the edition the Official Journal actually cites, because presumption of conformity attaches to the cited edition and not to the standard in the abstract. Every claim carries the ontology row id it came from, and the "Why?" line under each standard names the instrument it was read from. The regulatory statuses were verified against the consolidated EUR-Lex texts on 2026-08-17.
Laboratory counts are a dated snapshot of our own register, taken on 2026-08-18, not a live query. Each one says how it was counted: laboratories that hold a normalized method in an accredited scope, or laboratories whose published scope text references the standard. The second is a looser match and we say so rather than blend the two.
Looking for the laboratories rather than the requirements?
This page maps what testing a product class may need. Browse the laboratories accredited for medical-device matrices to go straight to the list instead. That page counts its laboratories live.
Do not see your product?
The list above is the whole family this map works from. If your product is not in it, or it sits in a row still in preparation, describe what you need in your own words or search the register directly.