GSPR checklist & compliance

Applies to

Both MDR 2017/745 and IVDR 2017/746. The GSPR checklist (cross-reference table) is a mandatory component of the technical documentation under Annex II of both regulations.

Disclaimer

This site provides general information only and does not constitute legal or regulatory advice. Always consult the official regulation text and a qualified regulatory professional.

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The GSPR cross-reference table

Manufacturers must prepare a GSPR cross-reference table — a structured document that maps each applicable GSPR to the evidence of compliance. This is required by MDR Annex II, Section 4, and is a key document reviewed by notified bodies.

The table must show, for each GSPR:

Column	Content
GSPR number	e.g. GSPR 1, GSPR 6, GSPR 23.2(a)
Applicability	Applicable / Not applicable
Justification if not applicable	Brief rationale (e.g. "Device is not sterile — GSPR 7 on sterility not applicable")
Method of demonstration	Harmonised standard / Common Specification / Other means
Standard or CS reference	e.g. EN ISO 14971:2019, EN ISO 10993-1:2018
Document reference	Internal document number or reference to test report, clinical evidence, etc.

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Checklist — MDR Annex I GSPR applicability by device type

Use this table as a starting point. Applicability depends on the specific device — confirm for each product individually.

Chapter I — General requirements

GSPR	Requirement summary	Passive device	Active device	Implantable	Software	IVD (IVDR)
1	Fundamental safety and performance	✅	✅	✅	✅	✅
2	Risk management	✅	✅	✅	✅	✅
3	Performance under transport/storage conditions	✅	✅	✅	✅	✅
4	Design, manufacture, packaging	✅	✅	✅	✅	✅
5	State of the art	✅	✅	✅	✅	✅

Chapter II — Design & manufacture

GSPR	Requirement summary	Passive device	Active device	Implantable	Software	IVD (IVDR)
6	Chemical, physical, biological properties	✅	✅	✅	❌	✅
7	Infection and microbial contamination	Depends on sterility	✅	✅	❌	✅
8	Devices with medicinal substance	Only if applicable	Only if applicable	Only if applicable	❌	❌
9	Devices with human/animal tissue	Only if applicable	Only if applicable	Only if applicable	❌	Only if applicable
10	CMR substances and endocrine disruptors	Depends on materials	Depends on materials	✅	❌	Depends on materials
11	Interaction with the environment	✅	✅	✅	✅	✅
12	Measuring function	Only if measuring function	Only if measuring function	Only if measuring function	Only if measuring function	✅
13	Protection against radiation	Only if radiation-emitting	✅ if radiation	Only if radiation	❌	❌
14	Active devices — energy sources	❌	✅	✅ if active	✅ if energy source	❌
15	Mechanical risks	✅	✅	✅	❌	✅
16	Energy supplied or emitted	❌	✅	✅ if active	❌	❌
17	Self-test / near-patient testing	❌	Only if self-test	❌	Only if self-test	✅ if POCT/self-test
18	Electromagnetic compatibility	Only if electrical	✅	✅ if active	✅	Only if electrical
19–22	Active and implantable device requirements	❌	✅	✅	✅	❌

Chapter III — Information supplied

GSPR	Requirement summary	Applies to
23.2	Label requirements	All devices
23.3	IFU on packaging	All devices
23.4	IFU content requirements	All devices

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Demonstrating compliance — choosing the right approach

Priority 1 — Harmonised standards (presumption of conformity)

If a harmonised standard covers the GSPR, use it. The presumption of conformity significantly simplifies notified body assessment. Check the Official Journal list of harmonised standards for MDR — not all ISO standards have been harmonised under MDR yet.

caution

Not all relevant ISO standards have been formally harmonised under MDR/IVDR. An ISO standard without harmonised status under MDR does not create a presumption of conformity — it is still useful as evidence but must be supplemented with additional justification.

Priority 2 — Common Specifications (CS)

Where the Commission has published CS, compliance is mandatory unless the manufacturer can justify an equivalent or better approach. Check the Official Journal for CS published for your device category.

Priority 3 — Alternative means

Any scientifically valid approach may be used. Document:

• The rationale for not using a harmonised standard or CS
• The alternative method or test applied
• The results and interpretation
• Why this approach is at least as rigorous as the standard approach

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Practical tips for building the GSPR table

1. Start with the GSPR text — read every requirement in Annex I before assessing applicability
2. Work with the intended purpose — applicability depends entirely on what the device does and for whom
3. Involve subject matter experts — biocompatibility (GSPR 6), EMC (GSPR 18), software (GSPR 17/21) require specialist input
4. Link to actual documents — the table should reference specific test reports, risk management outputs, and technical files by document number
5. Keep it current — the GSPR table must be reviewed and updated when the device changes or when post-market data triggers a review
6. Version control — the table is part of the technical documentation and must be under document control

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What notified bodies look for

Notified bodies assess the GSPR table as a core part of their technical documentation review. Common findings include:

• GSPR marked "not applicable" without adequate justification
• Non-harmonised standards cited without supplementary justification
• References to outdated versions of standards
• Test reports that do not cover the actual device (wrong specimen, wrong configuration)
• Missing GSPR — especially GSPR 10 (CMR) and GSPR 18 (EMC) for relevant devices
• No update after significant device change

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Related pages

• GSPR overview — Annex I
• Chapter I — General requirements
• Chapter II — Design & construction
• Chapter III — IFU & labelling
• Technical documentation — GSPR cross-reference
• Conformity assessment — overview

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Official references

Reference	Description
MDR Annex I	Full GSPR text
MDR Annex II, Section 4	GSPR cross-reference table requirement
IVDR Annex I	IVDR GSPR
Official Journal of EU	List of harmonised standards under MDR/IVDR
MDCG 2022-14	GSPR guidance
MDCG 2019-9	Summary of safety and clinical performance guidance