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).

Potential weaknesses (BSI auditor perspective)

Internal working document

These concerns were identified through a critical review from the BSI auditor's perspective. Items marked with risk level.

Low risk: CEP also lacks explicit cadence

The CEP (R-TF-015-001) mentions a "Mechanism for Future Updates" but does not state a fixed cadence. BSI's question is specifically about the CER, so this is unlikely to be raised in this round. However, if BSI reviews the CEP in a later round and finds the same omission, it could generate another item. Consider proactively adding the annual cadence to the CEP.

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

The CER says the next update is January 2027, and the PMCF plan says "after the first year of market placement." If CE marking is delayed beyond early 2026, the January 2027 date would be inconsistent with "one year after market placement." This is a timing issue, not a regulatory one — the annual cadence commitment is independent of the specific date.