MDR Annex I (GSPR) is the set of General Safety and Performance Requirements defined in Annex I of EU Regulation 2017/745. These 23 mandatory requirements specify the safety, performance, and risk criteria every medical device must meet, or justify as not applicable, before it can carry a CE mark and enter the EU market.
What is MDR Annex I (GSPR)?
The General Safety and Performance Requirements (GSPR) sit at the core of the EU Medical Device Regulation, Regulation (EU) 2017/745. They replaced the Essential Requirements set out in the older Medical Device Directive (MDD 93/42/EEC) and have applied to any device sold in the EU or EEA since the regulation’s date of application in May 2021.
Annex I organizes the requirements into three chapters: general requirements that apply to all devices, requirements covering design and manufacture, and requirements for the information supplied with the device. A manufacturer maps each applicable clause to documented evidence, building the spine of the technical documentation that a Notified Body reviews.
Why MDR Annex I (GSPR) Matters in Medical Device Development
Conformity with the GSPR is a legal precondition for placing a device on the EU market, set out in Article 5. Without a complete, evidence-backed Annex I assessment, a Notified Body will not issue a certificate, and the manufacturer cannot sign the EU Declaration of Conformity or apply the CE mark.
The stakes are practical as well as legal. A weak GSPR matrix is a common reason technical documentation gets rejected or returned with deficiencies, adding months to a launch. Gaps in risk management, clinical evidence, or labeling traceability surface here first. For Class IIb and Class III devices, scrutiny is stricter, and rework costs climb quickly.
How the GSPR Conformity Process Works
Demonstrating conformity follows a repeatable sequence:
- Determine applicability. Review all 23 requirements against the device’s intended purpose, marking each as applicable or not applicable. Every not-applicable decision needs a written justification.
- Select methods of conformity. For each applicable clause, decide how it will be met, often by applying a harmonized standard. Under Article 8, conformity with a harmonized standard creates a presumption of conformity with the linked requirement.
- Generate evidence. Produce the underlying records: risk management files per ISO 14971; biocompatibility data per the ISO 10993 series; electrical safety and EMC testing per the IEC 60601 family; sterilization and packaging validation; usability engineering per IEC 62366-1; and software lifecycle records per IEC 62304, where relevant.
- Build the GSPR matrix. Map every clause to its method and to the exact location of the evidence in the technical documentation, structured per Annex II.
- Maintain it. Update the matrix as the design, standards, or state of the art change across the lifecycle.
Auditors expect the matrix to track the device’s live state, not a snapshot frozen at submission.
Common Challenges and Best Practices
Teams often treat the GSPR matrix as paperwork completed at the end of development. That is where it goes wrong. The matrix should be drafted early and grow with the design, so evidence is generated on purpose rather than reconstructed under a deadline.
A few patterns separate clean submissions from troubled ones:
- Vague evidence references. Pointing to a full report rather than a specific section forces reviewers to hunt for it. Cite document, version, and section.
- Unjustified not-applicable claims. Marking a requirement not applicable without a rationale invites a deficiency. State the reasoning.
- Stale standard versions. Citing a superseded edition of a harmonized standard weakens the presumption of conformity. Confirm the current version before locking the matrix.
- Disconnected risk and labeling. Each risk control should trace to a GSPR clause, and the warnings in the instructions for use should match the controls claimed.
Good practice treats Annex I as the index to the whole technical file, kept current through change control.
How SJML Helps with MDR Annex I (GSPR)
SJML supports MDR Annex I work through its Compliance-as-a-Service team. The team builds and maintains GSPR matrices, assembles EU MDR technical documentation and design history files, and aligns risk management to ISO 14971 and usability files to IEC 62366-1. As an end-to-end CDMO, SJML also generates the underlying evidence: in-house electrical safety and EMC testing, biocompatibility planning, and packaging and sterilization validation support. This helps keep design, testing, and documentation connected as a device moves toward CE marking.
Talk to SJML’s QARA team →
Frequently Asked Questions
Annex I of EU Regulation 2017/745 contains 23 General Safety and Performance Requirements, organized into three chapters: general requirements, requirements for design and manufacture, and requirements for the information supplied with the device. Not every requirement applies to every device. Manufacturers must address each applicable clause with evidence and provide a documented justification for any clause marked not applicable.
The GSPR in EU MDR 2017/745 replaced the Essential Requirements of the Medical Device Directive (MDD 93/42/EEC). The GSPRs are more detailed and add stronger expectations around risk management, clinical evidence, usability, and post-market data. A device that was compliant under the old MDD checklist requires a fresh GSPR assessment, as the structure and content have changed significantly.
Using a harmonized standard is voluntary, but under Article 8 of the MDR, conformity with a harmonized standard gives a presumption of conformity with the requirements it covers. Standards such as the IEC 60601 family, ISO 14971, and ISO 11607 are common routes. Where a standard only partly covers a requirement, the manufacturer must supply additional evidence for the remainder.
The GSPR matrix, sometimes called the GSPR checklist or conformity table, is part of the technical documentation structured in accordance with Annex II of the MDR. It cross-references each applicable requirement to the specific evidence proving conformity, down to the document and section. Notified Bodies expect a complete, current matrix as a core part of any submission.
Related Terms
- EU MDR 2017/745
- ISO 14971
- Technical Documentation (Annex II)
- CE Marking
- Notified Body
