Research and planning

Internal working document

This page is for internal planning only. It will not be included in the final response to BSI.

Analysis

What BSI is asking: The CER section "Date of the next Clinical Evaluation" (the section BSI calls "§18") does not specify a regular cadence for CER updates (e.g., "every year", "every 2 years"). Instead, it presents conditional options from MEDDEV 2.7/1 rev 4 and gives a specific next-update date (January 2027) without committing to a recurring frequency. BSI wants a clear, unambiguous update frequency cadence aligned to MDR Articles 61(11) and 86.

What regulations are at stake

• MDR Article 86(2): "For class IIa and class IIb devices, the PSUR shall be updated when necessary and at least every two years." However, our device is Class IIb, and our PMS plan (R-TF-007-001) and PMCF plan (R-TF-007-002) already commit to annual PSUR updates, which exceeds the minimum Article 86 requirement. Note: BSI's question text states "at least every 2 years" for both IIa and IIb — this is a simplification. Article 86 actually requires at least every 2 years for IIa and IIb (and annually for III), but our QMS goes beyond this by committing to annual updates for our IIb device.

• MDR Article 61(11): "The clinical evaluation and its documentation shall be updated throughout the life cycle of the device concerned with clinical data obtained from the implementation of the manufacturer's PMCF plan [...] and the post-market surveillance plan [...]." This does not prescribe a specific frequency — it requires continuous updating based on incoming data. The practical mechanism is the PSUR cycle (which triggers CER updates).

• MEDDEV 2.7/1 rev 4, Section 6.2.3: The CER currently references this guidance, which gives tiered options (annually if significant risks/not well established; 2-5 years if well established). This is an MDD-era guidance document and while still referenced in practice, MDR Article 86 sets the binding minimum. The CER should reference MDR requirements as the primary authority, not MEDDEV guidance.

Underlying concern: BSI wants to see a firm commitment to a regular, predictable CER update cycle — not conditional language or one-off dates. The PSUR cycle drives CER updates, and the CER should explicitly state this linkage and the resulting frequency.

Relevant QMS documents and sections

Document	Path	Relevance
R-TF-015-003 CER, "Date of the next Clinical Evaluation"	apps/qms/docs/legit-health-plus-version-1-1-0-0/product-verification-and-validation/clinical/Evaluation/R-TF-015-003-Clinical-Evaluation-Report.mdx (line 1046)	The section BSI flagged. References MEDDEV 2.7/1 rev 4 conditional options. States next update January 2027. Does NOT state a regular cadence.
GP-015 Clinical Evaluation, "Updating the clinical evaluation"	apps/qms/docs/procedures/GP-015/index.mdx (line 195)	States "We have defined an annual update of the clinical evaluation." Also states updates triggered within one year if new PMS data has potential to change the evaluation. This is the procedure-level commitment BSI is looking for — it just needs to be mirrored in the CER.
GP-007 Post-market surveillance, "Frequency of updates"	apps/qms/docs/procedures/GP-007/index.mdx (line 230)	Defines PSUR frequency: "at least annually for class IIb and III medical devices."
R-TF-007-001 PMS Plan, "Planned PSUR"	apps/qms/docs/legit-health-plus-version-1-1-0-0/post-market-surveillance/R-TF-007-001-Post-Market-Surveillance-PMS-Plan.mdx (line 159)	States: "The PSUR will be updated at least every year and will summarize and analyze the results of the post-market surveillance activities described in this plan."
R-TF-007-002 PMCF Plan, "Estimated date of the PMCF evaluation report"	apps/qms/docs/legit-health-plus-version-1-1-0-0/post-market-surveillance/R-TF-007-002-Post-Market-Clinical-Follow-up-PMCF-Plan.mdx (line 190)	States: "The PSUR will be generated after the first year of market placement of the device and updated on an annual basis, as required for Class IIb devices."
R-TF-015-001 Clinical Evaluation Plan	apps/qms/docs/legit-health-plus-version-1-1-0-0/product-verification-and-validation/clinical/Evaluation/R-TF-015-001-Clinical-Evaluation-Plan.mdx	Mentions "Mechanism for Future Updates" but does not specify a fixed CER update cadence. Should also be checked for consistency.
R-TF-007-003 PSUR	apps/qms/docs/legit-health-plus-version-1-1-0-0/post-market-surveillance/others/R-TF-007-003-Periodic-Safety-Update-Report-PSUR.mdx	The PSUR itself. Should reference CER update alignment.

Gap analysis

What we have

The annual CER update cadence is already defined — just not in the CER itself:

1. GP-015 (procedure level): "We have defined an annual update of the clinical evaluation." (line 197)
2. GP-007 (procedure level): PSUR "at least annually for class IIb" (line 235)
3. R-TF-007-001 (PMS Plan): "The PSUR will be updated at least every year" (line 159)
4. R-TF-007-002 (PMCF Plan): "updated on an annual basis, as required for Class IIb devices" (line 190)
5. The CER itself already gives a next-update date of January 2027 (approximately 1 year after initial CE marking submission), which is consistent with an annual cycle.

What's missing (BSI's concern is valid but narrow)

The CER section "Date of the next Clinical Evaluation" (line 1046) has two problems:

1. References MEDDEV 2.7/1 rev 4 as the primary authority for update frequency, presenting conditional options ("annually if significant risks...; 2-5 years if well established"). Under MDR, the binding authority is Article 86 (for PSUR frequency) and Article 61(11) (for continuous CER updating). MEDDEV 2.7/1 is MDD-era guidance and should not be the primary reference for update cadence.

2. Does not state a regular cadence. Instead of writing "the CER will be updated annually," it gives a specific date (January 2027) and conditional language ("unless the manufacturer receives new information..."). BSI wants a clear, unconditional frequency commitment.

Root cause: The CER section was written following the MEDDEV 2.7/1 rev 4 template structure (which suggests conditional language), rather than directly referencing the MDR requirements and our own procedure GP-015, which already commits to annual updates.

Response strategy

Approach: Update the CER to explicitly state the annual update cadence, referencing MDR and GP-015

This is a narrow documentation gap. The annual cadence is already our policy (GP-015) and implemented in the PMS/PMCF plans. The CER just needs to reflect this clearly.

Fix required in R-TF-015-003 (CER)

Rewrite the "Date of the next Clinical Evaluation" section to:

1. State the regular cadence: "The clinical evaluation is updated annually, in alignment with the PSUR cycle for this Class IIb device."
2. Reference MDR as the primary authority: Cite Article 61(11) (continuous updating based on PMS/PMCF data) and Article 86 (PSUR frequency driving the update cycle), not MEDDEV 2.7/1 rev 4.
3. Reference GP-015: "This annual cadence is defined in our Clinical Evaluation procedure (GP-015)."
4. Keep the event-triggered update provision: "Additionally, the CER will be updated within one year if new PMS data is received that has the potential to change the current evaluation, per GP-015."
5. Keep the January 2027 date as the next specific update milestone, but frame it as the first instance of the annual cycle, not a one-off.

No fix needed in other documents

GP-015, GP-007, R-TF-007-001, and R-TF-007-002 all already state the correct annual cadence. They are consistent with each other and with the fix to the CER.

Optional: Check CEP (R-TF-015-001)

The CEP mentions "Mechanism for Future Updates" but does not specify a fixed cadence — it says updates will be triggered by emerging clinical concerns. Consider adding an explicit cadence statement to the CEP for full consistency, though this is not strictly required by BSI's question.

In the response to BSI

1. Acknowledge that the CER section did not specify a regular cadence.
2. State that the annual CER update cadence was already defined in GP-015 and implemented in the PMS and PMCF plans (R-TF-007-001 and R-TF-007-002).
3. Describe the CER update: the section now explicitly states annual CER updates aligned to the PSUR cycle, referencing MDR Articles 61(11) and 86.
4. Note that the first update is scheduled for January 2027 (approximately one year after initial market placement), with subsequent updates annually.
5. Reference red-lined CER documentation as evidence.

Confidence level: High. This is a straightforward documentation gap. The annual cadence is already our policy and practice — the CER just failed to state it clearly. The fix is a single-section rewrite with no impact on other documents. BSI should be satisfied with an explicit annual cadence statement referencing MDR requirements.

Key research findings

Finding 1: Annual cadence already defined at procedure level

GP-015, line 197: "We have defined an annual update of the clinical evaluation. The justification for this frequency will be included in the R-TF-015-001 Clinical Evaluation Plan and/or in the R-TF-015-003 Clinical Evaluation Report."

This is the key finding. GP-015 explicitly promises that the CER will contain the frequency justification — but the CER section currently references MEDDEV conditional options instead of stating the annual commitment. The fix fulfills the promise GP-015 already makes.

Finding 2: All PMS/PMCF documents are aligned on annual frequency

• R-TF-007-001 (PMS Plan): "at least every year" (line 159)
• R-TF-007-002 (PMCF Plan): "on an annual basis" (line 190)
• GP-007 (procedure): "at least annually for class IIb" (line 235)

There is no inconsistency across the QMS. The CER is the only document that does not clearly state the annual cadence.

Finding 3: MEDDEV 2.7/1 rev 4 is MDD-era guidance

The CER section references "section 6.2.3 of MEDDEV 2.7/1 revision 4 (June 2016)" as the basis for its update frequency logic. This guidance was written for the Medical Devices Directive (MDD) 93/42/EEC, not for MDR 2017/745. While still used as reference material, MDR Article 86 is the binding requirement. The CER should cite MDR as the primary authority.

Finding 4: Article 86 frequency depends on device class

BSI's question text simplifies by saying "at least every 2 years" for both IIa and IIb. MDR Article 86 actually states:

• Class IIa and IIb: PSUR updated "when necessary and at least every two years"
• Class III: PSUR updated "at least annually"

Our device is Class IIb, so the MDR minimum is every 2 years. However, our QMS commits to annual updates, which exceeds the minimum. The response should state the annual commitment without highlighting that we go beyond the minimum (per the CLAUDE.md principle: don't over-share).

Addressed weaknesses (BSI auditor perspective)

Internal working document

These concerns were identified through a critical review from the BSI auditor's perspective and have been proactively addressed.

Low risk: CEP also lacks explicit cadence

Observation: The CEP (R-TF-015-001) mentioned a "Mechanism for Future Updates" but did not state a fixed cadence. BSI's question was specifically about the CER, so this was unlikely to be raised in this round. However, if BSI reviewed the CEP in a later round and found the same omission, it could have generated another item. Resolution: We proactively added the annual cadence to the CEP to ensure consistency across all documents.

Low risk: January 2027 date assumes CE marking in early 2026

Observation: The CER stated the next update was January 2027, and the PMCF plan stated "after the first year of market placement." If CE marking was delayed beyond early 2026, the January 2027 date would be inconsistent with "one year after market placement." Resolution: We replaced the hardcoded "January 2027" date in both the CER and CEP with "one year after initial CE marking" to decouple the cadence from specific calendar dates and resolve this timing issue.

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Regulatory framework: what the BSI meeting revealed

Read this before finalising the response

The BSI clarification meeting (2026-03-25) with Erin Preiss and Nick revealed that refusal is extremely likely unless every gap is closed. Item 1 is categorised as minor in the action plan, but every weakness in the CER damages overall credibility. The response to this item must be unambiguous and must demonstrate regulatory grounding — not just a procedural commitment from GP-015.

The four applicable guidance documents

This item depends on understanding how MEDDEV 2.7.1 Rev 4 and MDCG 2020-6 interact. These are two of the four indispensable guidance documents Jordi identified and all four are stored in item-0/:

Document	Role for Item 1
MDR 2017/745, Articles 61(11) and 86	Binding primary authority. Article 86(2) sets the minimum PSUR update frequency for Class IIb devices (at least every two years). Article 61(11) requires continuous CER updating based on incoming PMS/PMCF data. These are not recommendations — they are legal obligations. The CER must cite these articles as the primary basis for its update cadence, not MEDDEV guidance.
MDCG 2020-6	Primary MDR-era guidance for legacy device clinical evaluation. This is the document BSI uses as its compliance reference when assessing the CER. It frames MEDDEV 2.7.1 Rev 4 as process methodology that supplements — but does not replace — MDR requirements. The relationship document stored in item-0/relationship-between-MDCG-2020-6-and-MEDDEV-2-7-1-rev-4/ confirms exactly which MEDDEV sections remain applicable under MDR.
MEDDEV 2.7.1 Rev 4	Applicable under MDR ONLY for the sections listed in MDCG 2020-6 Appendix I — confirmed by the relationship document. Section 6.2.3 (update cadence options: annually if significant risks; 2–5 years if well established) remains applicable but as process guidance, not binding authority. The CER's current reliance on MEDDEV 6.2.3 as the primary authority for its update cadence is therefore incorrect: MEDDEV provides the tiered options; MDR Article 86 sets the binding floor.
MDCG 2020-13	The CEAR template BSI uses to formally assess the CER. Section F explicitly checks the CER update schedule: BSI reviews the PMS Plan, PMS Report, PMCF Plan, PMCF Report, PSUR, and — critically — the CER update schedule. If the CER does not state a clear, unconditional update cadence, Section F cannot be completed, which is a blocking finding.

Why the combined MDCG + MEDDEV approach matters here

The team resolved after the BSI meeting to use a combined MEDDEV + MDCG approach. The practical consequence for Item 1:

• MDCG 2020-6 sets the requirement: the CER must document its update mechanism in a way that satisfies the MDR lifecycle requirements (Article 61(11), 86).
• MEDDEV 2.7.1 Rev 4, Stage 4 (continuous monitoring and CER updating) is the process framework: the CER's update cadence is Stage 4 of the MEDDEV clinical evaluation process. Nick stated: "Unless you complete stages 0, 1, 2, 3, 4, 5 — they won't work and it will fall down." Stage 4 is the PMS-driven update stage. Failing to state the Stage 4 update cadence clearly in the CER means Stage 4 cannot be demonstrated as complete.
• The relationship document confirms that MEDDEV Section 6.2.3 (update frequency guidance) remains applicable under MDCG 2020-6 Appendix I. This means the CER CAN reference MEDDEV 6.2.3 — but only to explain the tiered options that informed the choice of annual frequency, not as the primary authority for the cadence.

The required justification structure

The CER's update cadence section must be justified at three levels, with no ambiguity at any level:

1. Regulatory obligation (MDR): Class IIb device PSUR updated at least every 2 years per Article 86(2); CER continuously updated based on PMS/PMCF data per Article 61(11). We commit to annual frequency, which exceeds the Article 86 minimum.
2. Process compliance (MEDDEV 2.7.1 Rev 4, Section 6.2.3, applicable per MDCG 2020-6 Appendix I): The tiered options in MEDDEV 6.2.3 informed the choice of annual frequency. The device is Class IIb with ongoing clinical development and residual PMCF gaps — the MEDDEV framework supports annual updates for this profile.
3. Implementation (GP-015): The annual update cadence is defined in procedure GP-015 ("We have defined an annual update of the clinical evaluation"), with the first update scheduled one year after initial CE marking. The PSUR cycle (R-TF-007-001, R-TF-007-002) drives the CER update.

Any response to BSI that relies on only one or two of these levels is under-justified. The response must show all three layers explicitly.