CE Marking Process and Timeline

The CE marking process for bringing a medical device to market under the EU Medical Device Regulation (MDR) 2017/745 starts with one document that ties everything together: the technical documentation file, structured around MDR Annex II. This file is where every safety claim, design decision, test report and clinical justification for your device comes together into a single, audit-ready record. Because it draws on inputs from both the regulatory consultant and the manufacturer, a clear division of responsibility matters from day one. The table below sets out exactly that: every clause of Annex II, what it covers, and who is expected to deliver what, so nothing falls through the cracks.

The table is organized into eight sequential phases, from initial scoping through to final conclusion and approval, mirroring the natural order in which a technical file gets built. Each row maps to a specific Annex II clause and section number, paired with a plain-language description of what that section requires. Alongside it, two columns spell out the split in ownership: what I3CGlobal handles as your regulatory partner, and what falls to you as the manufacturer or client. Because MDR requirements shift depending on whether a device is sterile, implantable, an active non-implantable device, or a passive/non-implant device, several rows note where the applicable standards or test expectations diverge by device type.

Working from a shared, clause-by-clause reference like this keeps both sides aligned throughout the technical file build, and reduces the back-and-forth that usually slows down CE marking projects. It gives manufacturers visibility into exactly what evidence and documentation they need to prepare, and when, while giving I3CGlobal’s regulatory team a clear scope for review, compilation and Notified Body liaison. The result is a technical file that is complete, internally consistent, and structured the way assessors expect to see it. If you have questions about where your device fits, or which sections need particular attention for your specific product, our regulatory affairs team is ready to walk through it with you.

Annex II Clause	Description	Scope of I3CGlobal	Scope of Client
Phase 1 – Device Introduction
0	INTRODUCTION	Provide the overview and structure of the technical file as per the MDR Annex II framework. Define scope of technical documentation	Review and confirm the scope of technical documentation.
0	TECHNICAL FILE DETAILS	Frame the technical documentation file (TDF). Set up the cloud folder structure and share it with all stakeholders.	Provide internal document control and record control numbers as per EN ISO 13485 procedures.
0	REVISION HISTORY	Prepare and maintain the TDF revision history template; log changes at every review cycle / update as applicable (Until granting CE)	Inform I3CGlobal of any device or changes requiring a new revision entry.
0	WARNING	Insert the standard confidentiality/proprietary information notice as per company practice.	Confirm the confidentiality classification of the technical file as per EN ISO 13485 / GMP procedure.
0	TECHNICAL FILE	Compile and format the complete technical documentation file (TDF) as per MDR Annex II (both Part A and Part B annexures / supporting evidence).	Provide all device-specific source documents and data required for compilation wherever applicable and as per your availability.
0	PURPOSE	Draft the purpose statement of the TDF with reference to MDR 2017/745.	Review and approve the purpose statement.
0	SCOPE	Define the scope of the technical file, covering the device models/variants under review.	Confirm the exact models, variants and accessories to be included in the scope.
0	COMPANY PROFILE	Review and update in TDF	Provide company profile details – history, facilities, and certifications held.
0	LEGAL NAMES AND ADDRESS OF THE MANUFACTURER	Verify the manufacturer name and full manufacturing location address against any legal address proof issued by a government / central / state agency. Review the corporate office address if applicable and to be printed on the CE certificate.	Provide the manufacturer's name and registered address with supporting evidence. Provide contact information with the name of the person, designation and email.
0	EUROPEAN UNION AUTHORIZED REPRESENTATIVE	Review EAR agreement, mandate and EAR SRN details along with PRRC.	Confirm the appointment of the EU Authorized Representative and provide the mandate, agreement and SRN
0	NOTIFIED BODY	Provide guidance on Notified Body selection, ensuring the NB's designation scope covers the applicable device category, and prepare the section referencing NB details. Submit applications with multiple NBs if not applied	Provide the notified body name, identification number and certificate details (if already engaged).
Phase 2 – Device Description and Specification, Including Variants and Accessories / Components / Modules
1.1a	PRODUCT OR TRADE NAME	Format and insert the product/trade name in the document.	Provide the confirmed product/trade name(s).
1.1a	GENERAL DESCRIPTION	Draft the general description based on inputs, ensuring MDR-compliant language. Compile the device description section from the data supplied. Compile the description of the device housing/enclosure, applicable accessories (e.g., leads, probes, cables) and, where applicable, embedded firmware, and their interoperability at a high level. Review its consistency with the labelling	Provide the technical write-up about the device. Provide description of the device housing, accessories, and (where applicable) embedded firmware and their interoperability. Provide information on the intended anatomical/use site and method of use or implantation. Provide details of the device's operating environment (body contact, MRI conditionality, wireless connectivity, etc., where applicable)
1.1a	INTENDED PURPOSE	Review and refine the intended purpose statement for MDR compliance. Review its consistency with the labelling	Provide the intended purpose statement of the device.
1.1a	INTENDED USERS	Format the intended user profile section. Review the intended users based on the intended clinical use and clinical data Review its consistency with the labelling	Identify the intended user group(s) (e.g., healthcare professional, layperson).
1.1b	BASIC UDI-DI	Guide on basic UDI-DI generation and verify or validate the format the Issuing agency's guideline Review its consistency with the labelling	Generate and provide the basic UDI-DI via the assigned issuing agency.
1.1c	THE INTENDED PATIENT POPULATION	Review the intended patient population based on the intended clinical use and clinical data Review its consistency with the labelling	Provide the intended patient population details.
1.1c	MEDICAL CONDITIONS	Review the medical conditions based on the intended clinical use and clinical data Review its consistency with the labelling	Provide the medical condition(s) the device is intended to treat, diagnose or monitor.
1.1c	INDICATIONS	Draft the section format and cross-check consistency with labelling. Review the medical indications on the intended clinical use and clinical data Review its consistency with the labelling	Provide the indications for use.
1.1c	CONTRA-INDICATIONS	Draft the contraindications based on the labelling requirements from Risk and Clinical Evaluation	Provide contraindications, if any. Confirm the listed contraindications
1.1c	WARNINGS	Cross-check warnings against GSPR and labelling requirements from Risk and Clinical Evaluation	Provide the list of warnings/precautions associated with device use.
1.1d	PRINCIPLE OF OPERATION	Draft/review the principle of operation description for regulatory clarity.	Provide the technical explanation of how the device works (mechanism of action).
1.1e	MEDICAL DEVICE RATIONALE	Draft the rationale for qualifying the product as a medical device under MDR Article 2 or MDCG 2019-11	Provide supporting technical/clinical rationale and intended medical purpose evidence.
1.1f	DEVICE CLASSIFICATION AND JUSTIFICATION	Perform device classification per MDR Annex VIII and prepare the classification justification/rationale document per MDCG 2021-24, Rev.1; classify embedded firmware safety class per IEC 62304 where applicable.	Provide the details required for classification and review/approve the classification.
1.1g	EXPLANATION OF NOVEL FEATURES	Draft the section highlighting novel design features, materials, or (where applicable) algorithms/AI-ML functions, versus previous/prior-generation versions	Identify and describe the novel design features, materials, or (where applicable) algorithms/AI-ML functions, versus previous/prior-generation versions
1.1h	DESCRIPTION OF THE ACCESSORIES	Compile description of accessories (e.g., external programmer/controller, leads, cables, consumables) and their interaction with the device.	Provide description of all accessories supplied with or used alongside the device.
1.1i	DESCRIPTION OF THE VARIANTS	Send a requisition to the client for modules, versions or configurations, if applicable covered in the scope of TDF and prepare the consolidated section as per MDR Annex II, Section 1.	Provide the description of all device variants/models and their differences. Provide complete details of the modules, versions or configurations, if applicable
1.1j	COMPONENTS DESCRIPTION WITH DRAWINGS	Compile the component description section and insert engineering drawings/diagrams in the required format. Review the housing, connector and (where applicable) electronic assembly drawings and refine according to MDR and, where applicable, IEC 62304 requirements.	Provide engineering drawings, exploded views and component descriptions. Provide the electronic/firmware architecture diagram (where applicable) along with SOUP items and configuration components
1.1k	DESCRIPTION OF THE RAW MATERIALS	Review the raw materials list / Bill of Materials (BOM), including patient-contacting materials.	Provide the raw materials list / Bill of Materials (BOM) with material certificates/traceability.
1.1l	TECHNICAL SPECIFICATIONS	Compile and review the technical specification tables/section.	Provide detailed technical specifications (dimensions, weight, materials, performance parameters, power/battery, connectivity, ingress protection, etc. as applicable)
1.2a	AN OVERVIEW OF THE PREVIOUS GENERATION	Review the previous versions provided	Provide previous released versions in the market
1.2b	AN OVERVIEW OF EQUIVALENT OR SIMILAR DEVICES	Assist in identifying equivalent and similar devices and list them, with comparisons based on high-level technical specifications.	Provide technical and clinical information of the equivalent/similar device (if the equivalence route is pursued).
Phase 3 – Information to be Supplied by the Manufacturer
2	LABELS	Review label and symbol content against MDR labelling requirements (Annex I, 23.1–23.4) and ISO 15223-1 symbols; provide corrections.	Provide the content of all device labels and its deployment information
2	IFU	Review IFU content against MDR Annex I check requirements, risk, clinical and applicable standards and provide corrections.	Provide the draft Instructions for Use in all required languages.
Phase 4 – Design and Development Information
3a	DESCRIPTION OF THE DESIGN	Compile and review the device design description/design controls summary, covering mechanical, electronic (where applicable) and firmware (where applicable) design, and the development plan.	Provide design file extracts/design description as per ISO 13485 design control requirements (and IEC 62304 where firmware is present). Provide the device development plan
3b	MANUFACTURING PROCESSES	Review the manufacturing process flow and methodology shared	Provide the manufacturing process flow, methodology and process validation records (IQ/OQ/PQ) used for production
3b	FINAL PRODUCT SPECIFICATION AND TESTING	Compile the final product release specification and testing section. Compile/review the final acceptance/release test reports.	Provide final product/release specifications and QC test records. Provide final acceptance test reports (and firmware release notes, where applicable).
3b	MANUFACTURING ENVIRONMENTAL CONTROLS	Format the manufacturing environment/cleanroom controls section and cross-check against applicable standards.	Provide details of cleanroom classification (where applicable), environmental monitoring and contamination controls used in manufacturing
3c	SUPPLIERS AND SUBCONTRACTORS	Review the BOM and list the suppliers and subcontractors	Provide the list of critical suppliers/subcontractors, their roles and certificates (e.g., ISO 13485). Provide the BOM
Phase 5 – General Safety and Performance Requirements (GSPR)
4	THE GENERAL SAFETY AND PERFORMANCE REQUIREMENTS	Complete the GSPR checklist, referencing supporting evidence/documents, and identify gaps.	Provide test reports, standards compliance data and technical justifications for each GSPR.
4	DECLARATION OF CONFORMITY	Prepare the Declaration of Conformity as per MDR Annex IV.	Review and sign the Declaration of Conformity.
4c, 4d	LIST OF APPLICABLE LEGISLATION	Identify and compile the list of applicable EU legislation	Confirm any additional national/regional legislation applicable to the device.
4c, 4d	LIST OF APPLICABLE GUIDELINES	Identify and compile applicable MDCG guidance documents.	Review and confirm the applicability of the listed guidelines.
4c, 4d	LIST OF APPLICABLE HARMONIZED STANDARDS	Identify applicable harmonized standards (per the EU Official Journal) and compile the list.	Confirm standards tested against and provide certificates of compliance.
4c, 4d	LIST OF APPLICABLE NON-HARMONIZED STANDARDS	Identify relevant non-harmonized / state-of-the-art standards applicable to the device.	Confirm any additional standards followed and provide supporting test reports.
Phase 6 – Benefit-Risk Analysis and Risk Management
5a	THE BENEFIT-RISK ANALYSIS	Prepare/review the benefit-risk analysis and methodology as per Annex I, Chapter I.	Provide clinical/technical data supporting the benefit-risk determination.
5b	RISK MANAGEMENT	Review the risk management file against ISO 14971 (and IEC 62304 / ISO/IEC 27001 / MDCG 2019-16 where firmware or connectivity is present); identify gaps and provide corrective guidance.	Conduct the risk management activities and provide the complete risk management file (plan, analysis, evaluation, control, and report).
Phase 7 – Verification and Validation
6.1a	PRE-CLINICAL SAFETY	Review pre-clinical safety/bench data (and VAPT reports where the device is networked/wireless) for completeness against the GSPR.	Provide pre-clinical bench test reports and, where applicable, Vulnerability Assessment & Penetration Testing (VAPT) reports.
6.1b	BIOCOMPATIBILITY OF THE DEVICE	Review the biocompatibility evaluation/testing against the ISO 10993 series for all patient-contacting materials and identify gaps.	Provide biocompatibility test reports/biological evaluation per ISO 10993-1 for all body-contacting materials.
6.1b	ELECTRICAL SAFETY AND ELECTROMAGNETIC COMPATIBILITY	Review electrical safety and EMC test reports against the applicable IEC 60601 series (and ISO 14708 series where relevant) and identify gaps.	Provide electrical safety and EMC test reports per the applicable IEC 60601 series (and ISO 14708 particular standard where relevant).
6.1b	SOFTWARE / FIRMWARE VERIFICATION AND VALIDATION	Review software/firmware V&V documentation against IEC 62304 and MDR requirements; provide gap analysis.	Provide software/firmware development lifecycle documentation, verification/validation test plan & reports and the software safety & security risk management file.
6.1b, 6.2e	STERILIZATION	Review the sterilization validation (method, dose/cycle, SAL) against ISO 11135 / ISO 11137 / ISO 17665 as applicable and identify gaps.	Provide sterilization validation reports (method, SAL 10⁻⁶ demonstration) per the applicable ISO 11135/11137/17665 standard.
6.1b	STABILITY	Review shelf-life/aging (and, where applicable, battery longevity) stability data and identify gaps.	Provide shelf-life (real-time and accelerated aging) test reports, and battery longevity/stability data where applicable.
6.1c	CLINICAL EVALUATION	Prepare/review the Clinical Evaluation Report (CER) as per MEDDEV 2.7/1 Rev.4 and MDR and MDCG 2020-1 requirements.	Provide clinical data, literature search inputs and post-market clinical follow-up (PMCF) data as available.
6.1d	POST-MARKET ACTIVITIES	Prepare/review the PMS plan, PMS report/PSUR and PMCF plan templates.	Provide post-market surveillance data, complaints, vigilance reports and PMCF data.
6.1d,6.2e	PACKAGING AND TRANSPORTATION	Review packaging (sterile barrier where applicable) and transport/shipping validation against the applicable standards and identify gaps.	Provide packaging validation (ISO 11607-1/-2 where sterile) and transport/shipping simulation test reports.
6.2a	MEDICINAL PRODUCTS WITHIN THE MEANING OF DIRECTIVE 2001/83/EC	Not Applicable, unless the device incorporates a medicinal substance (e.g., a drug-eluting component).	Not Applicable, unless the device incorporates a medicinal substance.
6.2b	TISSUES OR CELLS OF ANIMAL ORIGIN	Not Applicable, unless the device incorporates animal-derived materials.	Not Applicable, unless animal-derived materials are used.
6.2c	DEVICES THAT ARE COMPOSED OF SUBSTANCES OR COMBINATIONS OF SUBSTANCES	Not Applicable, unless the device is absorbed by or locally dispersed in the human body.	Not Applicable, unless applicable to the device design.
6.2d	CMR OR ENDOCRINE-DISRUPTING ACTIVITY	Review device materials against MDR Annex I, Section 10.4 for CMR/endocrine-disrupting substances present above 0.1% w/w and prepare justification if present.	Provide a full material declaration and justification for any CMR/endocrine-disrupting substances present above 0.1% w/w.
6.2e	STERILIZATION	Cross-reference the sterilization validation summary compiled under Section 6.1.5.	Confirm sterilization method and validation status.
6.2f	MEASURING FUNCTION	Partially Applicable – where the device includes a measuring/sensing function, it is evaluated under device verification & validation. Review the accuracy/metrological verification data.	Provide accuracy/metrological verification data.
6.2g	COMBINATION WITH OTHER DEVICES	Partially Applicable – interfaces with accessories/consumables or connected devices are evaluated under device verification & validation. Review the list of interfaces/accessories.	Provide details of the interfaces/accessories connected to or used with the device.
0	MANUFACTURER DECLARATION	Prepare the manufacturer declaration template for the specific-case section.	Review and sign the manufacturer declaration.
Phase 8 – Conclusion and Approval
0	CONCLUSION AND APPROVAL	Prepare the final review summary and compile the complete technical file for client approval.	Perform the final review and provide sign-off/approval of the technical documentation.

CE Marking Process and Overall Timeline under new MDR?

It’s the first question every manufacturer asks, and rightly so, since timelines drive budgets, launch plans and investor conversations. Based on our experience guiding devices through Notified Body review, the typical MDR CE marking journey runs 18 months, from technical documentation preparation through to certificate issuance. The timeline below breaks that journey into clear, sequential phases, so you know exactly what’s happening at each stage, how long it takes, and where I3CGlobal’s regulatory team is working alongside you. Every device is different, but this gives you a realistic, experience-based benchmark to plan against.

Ready to get a realistic timeline for your own device? I3CGlobal’s regulatory team can review your product profile and map out exactly what MDR CE marking involves, phase by phase, month by month. No guesswork, no generic estimates. Submit your email for a quick response within minutes and take the first confident step toward CE certification.

*Page updated by Asha Johnson on August 24th 2026