Medical
medical device testing and certification
A device or accessory used for medical purposes.
medical device — conformity scope
For a medical device, classification determines everything: the risk class changes the conformity-assessment route, the clinical-data expectation and the notified-body requirement. For electrical devices, medical electrical safety and the EMC series, and for those with software, the software lifecycle, are part of the file.
The list below is the European Union framework. The same product falls under a different mark and approval regime in another market; Smart Service Finder shows that market's requirements when you select it.
Regulation
medical device legislation that typically comes into play for
The following is the European Union framework and shows typical application. Which title actually applies depends on the class, intended use and components of the product; The scope is determined by examining the product.
The Medical Device Regulation. Classification (I, IIa, IIb, III), clinical evaluation, technical documentation and post-market surveillance obligations; the notified body's role grows as the class rises.
The In Vitro Diagnostic Medical Devices Regulation. In vitro diagnostic devices fall under this regulation instead of the MDR.
The European medical device database. From 28 May 2026, the actor registration, UDI/device, certificate and market surveillance modules are mandatory; placing on the market is not possible without a valid SRN.
Relevant essential requirements also apply to medical devices that also qualify as machinery.
Restriction of hazardous substances in electrical and electronic equipment.
Registration, evaluation, authorisation and restriction of chemicals; SVHC notification.
Standards
Standards typically referenced in the dossier
- ISO 13485medical device quality management system
- ISO 14971
- ISO 10993
- ISO 10993-5in vitro cytotoxicity
- ISO 10993-10skin sensitivity assessment
- IEC 60601-1Basic safety in medical electrical devices
- IEC 60601-1-2electromagnetic compatibility in medical electrical devices
- IEC 62304medical device software lifecycle processes
- IEC 62366
- ISO 11135
- ISO 11137
- ISO 11607end product sterile barrier packaging
What is required?
Each item links to the relevant service page: the legislation entry to the certification scheme, the test family to the laboratory page, and the mark to the market page.
European Union — required mark
3- CE — European UnionThe umbrella for entering the EU market; all regulations applicable to the product are met.
- MDR — European UnionMedical Device Regulation — a notified body is involved depending on the risk class.
- IVDR — European UnionIn Vitro Diagnostic Regulation — classification is rule-based, most devices fall under NB scope.
Required legislation
3- Medical Device Regulation (MDR)
- In Vitro Diagnostic Regulation (IVDR)For products within IVD scope
- RoHS
Required tests
4- Medical Device TestingBiocompatibility and performance
- Electrical SafetyIEC 60601-1
- EMC / EMI TestingIEC 60601-1-2
- Packaging TestingSterile barrier and ISO 11607
Required certificates
2What must be in the technical file
6- Technical documentation (MDR Annex II–III)
- Risk management file (ISO 14971)
- Clinical evaluation report
- Post-market surveillance plan
- EUDAMED registration and UDI assignments
- Details of the authorised representative or importer established in the EU
How does the process work?
The flow below is a general order independent of product type; timing and acceptance criteria are determined by the standard the product falls under.
1Defining the scope
It is determined which legislation the product falls under based on its technical characteristics and intended use.
2Testing and evaluation
Tests are planned for the applicable headings; results are evaluated according to the relevant standards.
3Technical file
Design, production and test records are compiled in the technical file, accompanied by a risk assessment.
4Declaration or certificate
Depending on the product group, the manufacturer's declaration is prepared or third-party certification is carried out.
medical device which market is it going to?
Who bears the obligation, where the test will be performed, and what customs will require all vary by market.
What changes depending on the market?
Same product, different regimen
- European UnionA notified body is mandatory for devices other than Class I; the quality system is demonstrated via ISO 13485, risk management via ISO 14971, and biocompatibility via the ISO 10993 series. EUDAMED registration is required from 28 May 2026.
- United KingdomThe UKCA regime carries the same technical requirements into its own legislation; CE marking is recognised indefinitely for many product groups.
- United StatesThe FDA 510(k) or PMA route is followed; from 2 February 2026, the quality system is audited under QMSR (21 CFR Part 820, referencing ISO 13485:2016).
medical device — let's work out the scope together
Share the product's technical characteristics; let us tell you in writing which headings apply to your scope and which tests are required.
This result is a starting roadmap, not a conformity assessment. Which legislation a product falls under depends on its technical characteristics, intended use and user group; it is only finalised by examining the product. You may have an obligation not shown in the list, and an item shown here may not apply to your product.