GP-032 CE Mark Process (MDR)

Procedure flowchart

Purpose

This procedure defines the end-to-end process to obtain and maintain CE marking under Regulation (EU) 2017/745 (MDR). It integrates internal experience from BSI non-conformities and ensures that submissions are complete, traceable, and audit-ready before and after Notified Body (NB) assessment.

Scope

This procedure applies to all devices that require CE marking under MDR and to all lifecycle stages relevant to conformity assessment: initial MDR certification, significant changes, surveillance and recertification, legacy-transition contexts under MDR transitional provisions (where applicable), and post-market maintenance of CE compliance.

References

Reference	Description
Regulation (EU) 2017/745	Medical Device Regulation (MDR)
MDR Annex I	General Safety and Performance Requirements (GSPR)
MDR Annex II and III	Technical documentation and PMS documentation
MDR Annex XIV	Clinical evaluation and PMCF
MDCG 2020-1	Clinical evaluation guidance for MDSW
MDCG 2020-5	Clinical evaluation equivalence
MDCG 2020-6	Sufficient clinical evidence for legacy devices
MDCG 2020-7	PMCF Plan template
MDCG 2020-8	PMCF Evaluation Report template
MDCG 2020-13	Clinical Evaluation Assessment Report (CEAR) template
MDCG 2022-21	PSUR guidance
MEDDEV 2.7/1 rev.4	Clinical evaluation methodology (as applicable under MDCG 2020-6)
ISO 13485:2016	QMS requirements
ISO 14971:2019	Risk management
IEC 62304	Software lifecycle processes
IEC 62366-1	Usability engineering

Responsibilities

JD-001

• Approve CE marking strategy and major submission decisions.
• Approve final submission package prior to NB submission.

JD-003

• Lead regulatory strategy and conformity assessment planning.
• Own NB submission package assembly and submission coordination.
• Coordinate responses to NB questions and NCs.

JD-004

• Ensure QMS integration, document control, and record completeness.
• Verify traceability, consistency, and archival of CE evidence.

JD-005

• Lead clinical strategy, CER, PMCF, and clinical evidence rationale.
• Ensure alignment with MDR Annex XIV and MDCG clinical guidance.

JD-007

• Provide product technical evidence (software, cybersecurity, V&V).
• Support closure of technical NCs.

Detailed process

1. Define CE regulatory strategy

1. Confirm qualification, intended purpose, and classification.
2. Confirm conformity assessment route and NB interaction plan.
3. Define applicable standards and guidance baseline.

2. Build submission architecture

1. Structure technical documentation per MDR Annex II and III.
2. Define traceability chain:
   • intended purpose -> claims,
   • claims -> acceptance criteria,
   • acceptance criteria -> evidence,
   • evidence -> analysis and conclusions.

3. Clinical evidence strategy and execution

1. Ensure CER is standalone and reviewer-readable.
2. Ensure each claim has explicit evidence mapping and rationale.
3. Define PMCF linked to specific identified gaps.
4. Narrow claims before submission if evidence is insufficient.

4. Pre-submission readiness review

Run a formal checklist for Annex I, Annex II/III, CER traceability, risk consistency, and IFU claim consistency.

5. NB submission and interaction management

1. Submit controlled package version.
2. Log questions/NCs and assign owners.
3. Close findings through evidence-backed document updates.

6. Certification and post-market maintenance

1. Finalize certificate scope and Declaration of Conformity.
2. Maintain PMS/PMCF/PSUR/vigilance obligations and change control.

Lessons integrated from BSI non-conformity experience

1. Traceability must be explicit end-to-end.
2. CER must be self-sufficient.
3. Use exact MDR/MDCG language expected by reviewers.
4. Do not rely on future PMCF to justify current evidence gaps.
5. PMCF activities must be specific, measurable, and gap-linked.
6. Risk and clinical evidence must remain cross-consistent.