CE-Mark Planning Checklist

Scoring System

Total Score: 0 to 42

0Not started or missing
1In progress or incomplete
2Complete & verified or not applicable

General Regulatory Preparedness

Have you determined the correct device classification (Class I, IIa, IIb, III)?

Regulators reference: MDR Annex VIII

0 1 2

Refer to MDR Annex VIII and identify the classification rule applicable to your device.
Double check classification rule and consult guidance for edge-case interpretation.
No action needed - checkpoint completed

Is your intended purpose clearly defined and aligned across all documents?

Regulators reference: MDR article 2(12), Annex I

0 1 2

Draft a clear, MDR-compliant intended purpose and ensure alignment across all documents.
Ensure intended purpose is fully aligned with labelling, IFU, CER, and PMCF.
No action needed - checkpoint completed

Have you appointed a PRRC (Person Responsible for Regulatory Compliance)?

MDR Article 15

0 1 2

Identify a qualified internal or external person per Article 15 and start documentation.
Finalize PRRC appointment with documented roles and QMS responsibilities.
No action needed - checkpoint completed

Have you identified your conformity assessment route?

MDR Annexes IX–XI

0 1 2

Review Annex IX-XI to determine appropriate conformity route.
Confirm NB requirements for selected conformity route; document rationale.
No action needed - checkpoint completed

If applicable, have you engaged with a suitable notified body?

MDR Article 52

0 1 2

Begin searching for suitable notified bodies (NB) as soon as possible. Use the NANDO website to identify NB designated for your device type. Also consider price, communication, customer service, NB business processes and timelines in your decision making.
Once a NB is selected, arrange a business agreement as soon as possible. Engage early on with the NB to setup any audits.
No action needed - checkpoint completed

Technical Documentation (Annex II & III)

Is your device description section complete with variants, accessories, and UDI?

Annex II, Section 1

0 1 2

Prepare a complete device description with all variants, accessories, and UDI info.
Verify consistency of description across CER, IFU, and Declaration of Conformity.
No action needed - checkpoint completed

Are your risk management file, clinical evaluation, and post-market surveillance interlinked?

Annex I, Chapter I & Annex II

0 1 2

Start ISO 14971 risk assessment and link to clinical, usability data, and PMS data.
Link risk control measures to benefit-risk data and residual risk statements.
No action needed - checkpoint completed

Are your design and manufacturing processes fully documented and traceable?

Annex II, Section 3

0 1 2

Document all manufacturing steps, including suppliers and traceability elements.
Add traceability details and ensure alignment with EN ISO 13485 documentation.
No action needed - checkpoint completed

Have you completed your General Safety and Performance Requirements (GSPR) checklist with traceable evidence for supporting each criterion?

Annex II, Section 4.1

0 1 2

Prepare a GSPR checklist and identify all the criteria relevant to your device. Ensure this checklist references supportive data to facilitate audits.
Close any gaps in evidence to demonstrate compliance to the GSPR
No action needed - checkpoint completed

Clinical Evaluation & PMS Planning

Is your Clinical Evaluation Report (CER) compliant with Annex XIV & MDCG 2020-13?

Annex XIV Part A

0 1 2

Review MDCG 2020-13 and Annex XIV; initiate structure for CER.
Ensure CER reflects latest guidance and aligns with clinical claims and IFU.
No action needed - checkpoint completed

Have you completed a robust literature review or clinical investigation (if required)?

Annex XIV

0 1 2

Start a documented literature review or clinical plan based on device classification.
Ensure review protocol is systematic and includes current clinical data.
No action needed - checkpoint completed

Is a PMCF Plan prepared and justified?

Annex XIV Part B & MDCG 2020-7

0 1 2

Assess need for PMCF and prepare plan or justification accordingly.
Refine PMCF objectives, methodology, and link to PMS and CER.
No action needed - checkpoint completed

Are your PMS Plan and PSUR/SSCP aligned with Article 83 and Article 86-87?

Articles 83–86

0 1 2

Draft a PMS plan with key metrics and define PSUR/SSCP requirements.
Ensure PMS plan covers all post-market data sources and report intervals.
No action needed - checkpoint completed

QMS Alignment (ISO 13485 + MDR Requirements)

Is your ISO 13485:2016 certificate up-to-date and includes MDR-specific processes?

Article 10(9)

0 1 2

Begin ISO 13485 implementation or initiate recertification with MDR updates.
Verify certificate scope includes MDR processes and required jurisdictions.
No action needed - checkpoint completed

Are roles, responsibilities, and training documented and traceable?

Annex IX / ISO 13485 Clause 6

0 1 2

Define RA/QA roles, map training needs, and create traceability matrix.
Link training records to competencies and maintain audit readiness.
No action needed - checkpoint completed

Are CAPA, complaints, vigilance, and field safety processes integrated in QMS?

Annex III / Article 87

0 1 2

Develop CAPA, vigilance, FSCA procedures as part of QMS structure.
Integrate vigilance and CAPA into ongoing PMS/QMS feedback loops.
No action needed - checkpoint completed

Is your supplier control documented and risk-based?

Annex II, Section 3 / ISO 13485 Clause 7.4

0 1 2

Map suppliers, define evaluation criteria, and draft quality agreements.
Risk-rank suppliers and include audit records and change notification plans.
No action needed - checkpoint completed

Labelling, UDI & EUDAMED

Are labels, IFUs, and packaging validated and compliant with MDR Annex I, Section 23?

Annex I, Chapter III

0 1 2

Draft labelling and IFU to Annex I, Section 23; validate content with users.
Run internal validation and UDI review checklist on all labelling assets.
No action needed - checkpoint completed

Is Basic UDI-DI assigned and correctly used across all documentation?

Article 27 / Annex VI Part C

0 1 2

Assign a Basic UDI-DI and start preparation for labelling and system integration.
Confirm UDI is implemented across labels, EUDAMED, and technical file.
No action needed - checkpoint completed

Are you registered as a manufacturer in EUDAMED (or prepared to do so)?

Article 29

0 1 2

Collect data required for EUDAMED registration and initiate SRN application.
Verify pending SRN or onboarding documents with NB or competent authority.
No action needed - checkpoint completed

Have you prepared and formatted your SSCP (if Class III or implantable)?

Article 32 / MDCG 2019-9

0 1 2

Verify if SSCP is required; initiate draft using MDCG 2019-9 guidance.
Align SSCP with CER claims and test formatting per MDCG recommendations.
No action needed - checkpoint completed

Result

Critical Risk

Immediate regulatory support needed

Moderate Risk

Review and close gaps before NB engagement

Almost Ready

Final review recommended

Strong Foundation!

Consult with regulatory partner to prepare for final review and regulatory alignment

Contact Now!

Right here at the booth to help you!

Heike Schön
Founder and CEO
Liam Spencer
Head of Regulatory Services
Lars Bak-Christensen
Business Development Manager
Nasim Moradi
Marketing and Team Assistant

Disclaimer

This checklist is intended for informational and internal planning purposes only. It is not a regulatory validation tool, nor does it constitute a complete assessment of conformity under Regulation (EU) 2017/745. Completion of this checklist does not confirm regulatory compliance or readiness for CE-marking submission.

For a complete and reliable regulatory evaluation, we strongly recommend engaging a qualified regulatory professional. Lumis International GmbH accepts no responsibility for decisions made on this preliminary tool without formal consultation.