Start with the device and the applicable EU rules
The Medical Device Regulation, Regulation (EU) 2017/745 (MDR), and the In Vitro Diagnostic Medical Device Regulation, Regulation (EU) 2017/746 (IVDR), cover different product scopes. The IVDR concerns devices intended to examine human specimens for specified medical purposes. Intended purpose matters: equipment used in a hospital or laboratory is not automatically a medical device or IVD. Check accessories and any relevant exclusions; the MDR also covers specified products without a medical purpose listed in Annex XVI.
Document the product’s qualification, classification and applicable conformity assessment route before commissioning work. The manufacturer remains responsible for demonstrating conformity. Use the MDCG medical-device classification guidance and IVD qualification guidance alongside the legislation. Guidance supports interpretation; it is not legally binding.
How harmonised standards support MDR and IVDR
Using harmonised standards is voluntary. Where an applicable standard’s reference is published in the Official Journal of the European Union, using it can give a presumption of conformity only with the regulatory requirements it covers. An EN, ISO or IEC label alone does not establish that status. Check the separate MDR and IVDR references on the Commission’s harmonised-standards page.
Match the exact European edition and amendments, any limitations in the citation, and the requirements mapped in its informative Annex Z. A newer international edition is not automatically the version cited for EU purposes. Record the standards and alternative technical solutions used, the requirements they address and remaining evidence gaps. The MDCG guidance on standardisation explains these distinctions. Common specifications are a separate regulatory instrument and should also be checked where relevant.
Standards to consider for your device
This is a selection guide, not a mandatory or exhaustive list of harmonised editions. Confirm scope and the relevant European adoption before purchasing a document or specifying tests.
| Standard or family | What it addresses | What to check |
|---|---|---|
| ISO 13485 / EN ISO 13485 | Quality management systems for medical-device organisations. | The organisation, activities and sites covered. QMS certification alone does not establish device conformity or authorise CE marking. |
| ISO 14971 / EN ISO 14971 | A lifecycle process for identifying hazards, evaluating and controlling device risks, and monitoring controls. | Device-specific risks, benefit–risk decisions and production or post-production information. It does not prescribe universally acceptable risk levels. |
| IEC 60601-1 and related EN standards | Basic safety and essential performance of medical electrical equipment. | Whether the equipment is in scope and which collateral or particular standards apply. Part 1 should not be used alone where a particular standard applies. |
| ISO 10993 / EN ISO 10993 series | Biological evaluation within a risk-management process. | Materials, direct or indirect body contact and exposure duration. Establish an evaluation plan before ordering a generic test package. |
| ISO 15223-1 / EN ISO 15223-1 | Symbols used with information supplied for medical devices. | Relevant symbols and amendments alongside the applicable labelling and language requirements. |
| IEC 62304 / EN 62304 | Development and maintenance processes for medical-device software. | Software scope and lifecycle evidence. This standard does not cover validation and final release of the complete medical device. |
Connect standards to the evidence you need
Keep the conformity assessment plan, technical documentation and risk-management work connected. For MDR devices, clinical evaluation addresses the clinical evidence supporting safety, performance and, where relevant, clinical benefits. For IVDs, performance evaluation considers scientific validity, analytical performance and clinical performance as applicable. A laboratory test report or an ISO 13485 certificate cannot replace these evaluations. Relevant starting points include MDR Article 61 and Annex XIV, IVDR Article 56 and Annex XIII, and the MDCG guidance on IVD clinical evidence. Use the Commission’s legislation overview to check amendments and current consolidated texts.
ISO 13485 certification is not CE marking. It assesses a defined quality-management-system scope. It does not by itself certify every product, complete the MDR or IVDR conformity assessment route, or remove the manufacturer’s obligations. ISO develops standards; external certification bodies issue certificates. Ask what the certificate covers, who issued it and whether it is valid.
Plan how post-market information will update risk and clinical or performance evidence. For legacy devices, assess transition eligibility separately against the current rules; do not infer eligibility from a standards certificate or an old conformity-assessment document. The Commission’s current guidance index includes post-market and transition resources.
Choose the right type of specialist support
- Regulatory, clinical or QMS consultants: define the work required, such as a classification rationale, evidence-gap assessment, risk-management support or QMS implementation. Ask for relevant device experience and clear deliverables.
- Laboratories: agree the test method and edition, specimen requirements, applicable scope of accreditation and reporting needs. Laboratory accreditation does not make the laboratory a notified body or approve the device.
- Certification bodies: clarify whether the engagement is for ISO 13485 QMS certification and verify its scope.
- Notified bodies: where the route requires one, check designation under the correct regulation and for the relevant device scope through the Commission’s notified-body information and NANDO links. Consultancy or testing alone does not constitute that conformity assessment.
Prepare a short brief with the device and intended purpose, target markets, proposed classification, project stage, evidence available, required deliverable and timing. Request medical-device regulatory support or laboratory support according to the work needed. Before appointing a laboratory, use our accreditation-scope checklist. An introduction does not guarantee provider acceptance or a regulatory outcome.
Find standards in the catalogue
Compare document scope, edition, amendments, language and licence terms before purchase. The external catalogue is a discovery and purchasing route; a catalogue listing does not prove harmonisation or suitability for your device.
Explore Standards for Other Industries
Navigate to other key sectors to find relevant European and International standards.