CE Marking Process For Medical Devices In The Eu

Scope and evidence must be confirmed before any paid tests or filings.

CE marking under Regulation (EU) 2017/745 (MDR) is the manufacturer’s declaration of conformity after the applicable assessment—not a general EU permission or an automatically required third-party certificate. The practical sequence depends on the device’s intended purpose, risk class and special features. A wrong classification can invalidate the chosen route.

First decide whether the MDR route applies

Fix the intended medical purpose, claims, user, patient population, mode of action and use environment before selecting a conformity assessment path. Conventional medical devices and relevant accessories may fall under the MDR; in-vitro diagnostic devices generally follow Regulation (EU) 2017/746 (IVDR), not this route. Certain products without a medical purpose are covered by MDR Annex XVI and common specifications. Custom-made, investigational and qualifying legacy devices require separate analysis: the ordinary CE route below cannot simply be applied to them.

Conformity assessment route by device class

Class is determined by MDR Article 51 and Annex VIII, considering all applicable rules; where more than one rule applies, the more stringent classification governs. The April 2026 revision of MDCG 2021-24 is interpretive guidance, not a replacement for the Regulation. These rows are orientation gates, not final product classifications.

Device/route	Assessment involvement	Decision before launch
Class I, non-sterile, non-measuring, not a reusable surgical instrument	Manufacturer conducts assessment, prepares MDR technical documentation and EU declaration of conformity; normally no notified body for this route.	Verify that no Annex VIII rule or feature moves the product into another row.
Class I supplied sterile (Is), with measuring function (Im), or reusable surgical instrument (Ir)	Notified body is required, but its intervention is limited to relevant sterility, metrological or reprocessing aspects under Article 52(7).	Define each special feature and the restricted review scope; do not call this unrestricted self-certification.
Class IIa	Notified-body conformity assessment under the applicable MDR Annex IX route or permitted alternatives in Article 52.	Identify the designated body and the applicable technical-documentation sampling requirements.
Class IIb or III	Notified-body assessment is required; the documentation review and, for certain products, additional procedures vary by class, implantability and technology.	Confirm Article 52 branch and possible consultations before requesting a proposal.
Custom-made or investigational; eligible legacy product	Special MDR provisions or transitional conditions apply; ordinary CE-marking steps may be inappropriate. For class III custom-made implantable devices, Article 52(8) additionally requires notified-body conformity assessment; this is not the ordinary CE-marking route. For class III custom-made implantable devices, Article 52(8) specifies Annex IX, Chapter I, or alternatively Annex XI, Part A, in addition to Annex XIII; it does not substitute the full ordinary class III CE route.	Check Articles 20, 52, 62 onward, 120 and Annex XIII as applicable before deciding.

A six-gate process from intended purpose to CE mark

Freeze the intended purpose and legal-manufacturer identity; screen the MDR/IVDR boundary, accessories and Annex XVI before preparing a quote or submitting samples.
Document the classification rationale rule by rule under Annex VIII, including software, invasiveness, duration of use and any sterile, measuring or reusable-surgical feature.
Build the manufacturer’s Article 10 quality management system, risk management and clinical evaluation processes; allocate an Article 15 person responsible for regulatory compliance. A manufacturer outside the EU appoints an EU authorised representative under Article 11.
Compile Annex II/III technical documentation and evidence for Annex I general safety and performance requirements (GSPRs); resolve test, usability, biological, software, clinical and manufacturing gaps that apply to this device.
If the selected route requires a notified body, verify its MDR designation and device-code scope in NANDO, submit the agreed assessment package and close nonconformities. Do not mistake laboratory testing or an ISO certificate alone for MDR certification.
After completing the applicable conformity assessment, draw up and maintain the Annex IV EU declaration of conformity and affix the CE mark under Article 20 and Annex V (with the notified-body number where required). Before first placing the device on the EU market, complete applicable actor and device registration in EUDAMED and UDI obligations, taking account of any specific transitional provision. Continue post-market surveillance, vigilance and change control.

Evidence pack: what must be defensible

Use this document-to-decision crosswalk as a release review. Regulation (EU) 2017/745 is binding law; harmonised standards can give a presumption of conformity only for requirements they cover, while MDCG guidance supports interpretation. ISO 13485 certification by itself is not the CE mark. For a harmonised standard to provide that legal presumption, its reference must also be published in the Official Journal of the EU.

Intended-purpose statement, claims set and Annex VIII classification memo, with every potentially applicable rule addressed. Decision: does the stated purpose support the selected legal scope and class?
Annex I GSPR matrix linking each applicable requirement to a test, analysis, procedure or reasoned non-applicability. Decision: can every applicable GSPR be substantiated?
Risk-management file, benefit–risk conclusions and engineering verification/validation including device-relevant safety and performance tests. Decision: is the benefit–risk balance supported by relevant verification and validation?
Clinical evaluation and supporting data under Article 61/Annex XIV; assess whether a clinical investigation is needed rather than presuming every device requires one. Decision: is clinical evidence sufficient for this device and is an investigation needed?
Annex II/III technical file, manufacturing controls, QMS and PRRC arrangements; notified-body applications/certificates when required. Decision: are manufacturing controls and any required notified-body assessment complete?
Labels and instructions for use, UDI/Basic UDI-DI decisions, declaration, EUDAMED records and a post-market surveillance plan (including PMCF or a documented justification where applicable). Decision: are labelling, declaration, registration and PMS ready before market entry?

Hold points that change the route

Use a stop/go review before distributing any units. These are practical checks derived from the MDR, not a separate official EU approval procedure.

Trigger	What to verify	Safe next action
“Class I” but sterile, measuring or reusable surgical	Check product configuration and Article 52(7).	Engage an appropriately designated notified body for the limited scope before release.
Software claim changes from storage to diagnosis or therapy support	Re-run Annex VIII, notably Rule 11 where applicable, and refresh clinical/risk evidence.	Reassess class and procedure before changing claims or release.
Legacy certificate or custom-made prescription offered as ordinary CE evidence	Check eligibility, restrictions and applicable special/transitional articles. A patient-matched or industrially adapted device is not automatically a legally custom-made device; verify the statutory definition and manufacturing method.	Document the separate route; do not apply a new-device CE checklist blindly.

EUDAMED registration before market entry and continuing duties

Since 28 May 2026, four EUDAMED modules are mandatory: actor registration, UDI/device registration, notified bodies and certificates, and market surveillance. The market-surveillance module is for competent authorities and the European Commission, not a manufacturer filing step. For a new MDR device first placed on the EU market on or after that date, check actor registration/SRN and required UDI/device registration before first placing on the market; notified bodies register the certificates for which their module applies. Devices already placed on the market before mandatory use and eligible legacy devices may have different transitional registration treatment: check the precise device, first-placement date, continued placing and current Commission guidance instead of assuming a single deadline. The vigilance/post-market-surveillance and clinical-investigation modules are not yet mandatory as of this review; the underlying vigilance and PMS legal duties still apply. CE marking also leaves applicable market-language, importer/distributor and change-control obligations in force. The actor module also covers EU and non-EU manufacturers, EU authorised representatives and importers: verify the separate actor registration/SRN appropriate to each operator, rather than treating the manufacturer’s SRN as the importer’s registration.

What to do with your device now

Prepare a one-page input pack: product description and claims, intended users/patients, mechanism of action, software functions, contact/invasiveness and duration, sterile/measuring/reusable status, manufacturer location, current certificates and planned first EU sale date. The first safe output is a written MDR-versus-IVDR scope and Annex VIII class rationale, followed by a route-specific evidence gap list and notified-body scope check if relevant. For narrower questions, use the related pages:

Official legal and regulatory sources

Device-specific questions

Can a class I device receive the CE mark without a notified body?

Yes for a genuinely ordinary class I device after the manufacturer meets MDR duties and issues its declaration. Class Is, Im and Ir require notified-body intervention limited to specified aspects; class must be substantiated.

Does a notified body issue the CE mark?

No. When its involvement is required it issues the relevant MDR certificate(s); the manufacturer issues the EU declaration and affixes the CE mark. The notified-body number accompanies the mark when required.

Is ISO 13485 certification enough to sell a medical device in the EU?

No. The MDR requires conformity with applicable requirements, evidence and the proper Article 52 route. A QMS standard or its certificate cannot replace technical documentation, clinical evaluation or an applicable notified-body assessment.

Does every medical device need a clinical investigation?

No automatic rule applies to every device. Clinical evaluation is required; whether new clinical investigations are needed depends on the device and the evidence/requirements, especially Article 61 and the implantable/class III rules.

Can an MDD-era certificate or a custom-made prescription be used for ordinary CE marking?

Not without a specific route analysis. Article 120 transitional eligibility is conditional. Custom-made devices follow Annex XIII and normally do not bear the ordinary CE mark; class III custom-made implantable devices additionally require notified-body assessment under Article 52(8). A prescription alone is not evidence of ordinary CE conformity. For a class III custom-made implantable device, the additional assessment is Annex IX, Chapter I, or Annex XI, Part A. A patient-specific prescription does not by itself make an industrially manufactured product custom-made.

Who enters devices and certificates in EUDAMED after 28 May 2026?

Manufacturers must check applicable actor and UDI/device registration before first placing new MDR devices on the EU market; notified bodies register MDR certificates in the relevant module. The market-surveillance module is operated by authorities. For devices first placed before 28 May 2026 or legacy devices, verify transitional rules before choosing a registration deadline.