Updated August 2026. Scope: EU MDR 2017/745, Annex I, the General Safety and Performance Requirements. For the short definition, see the GSPR glossary entry.
Key takeaways
- The General Safety and Performance Requirements (GSPRs) are the requirements in MDR Annex I that every device must meet. They are the MDR successor to the old directive’s Essential Requirements.
- Annex I holds 23 requirements in three chapters: general requirements, design and manufacture, and the information supplied with the device.
- Not every requirement applies to every device. The design-and-manufacture requirements depend on the technology, and you justify in writing any requirement you mark not applicable.
- The GSPR checklist is the backbone of the technical documentation, the core of the notified body assessment, and the legal basis for the EU declaration of conformity.
What the GSPRs are
MDR Annex I sets out the General Safety and Performance Requirements. Meeting the applicable GSPRs is what it means, at the technical level, for a device to be safe and to perform as intended under the MDR. If you worked under the old Medical Device Directive, the GSPRs are the evolution of the Essential Requirements, expanded and reorganised.
There are 23 GSPRs, and the way to read them is by chapter, because the chapters do different jobs.
The three chapters
| Chapter | Requirements | What it covers |
|---|---|---|
| I. General requirements | 1 to 9 | The overarching duties: the device achieves its intended performance and is safe; risks are reduced as far as possible; a risk management system is in place; the benefit-risk profile is acceptable across normal use and foreseeable misuse |
| II. Requirements regarding design and manufacture | 10 to 22 | The technology-dependent requirements: chemical, physical and biological properties; infection and microbial contamination; devices incorporating substances or materials of biological origin; devices with a measuring function; protection against radiation; electronic programmable systems and software; active and connected devices; mechanical, thermal and energy risks; and protection for lay users |
| III. Information supplied with the device | 23 | The label and the instructions for use |
Chapter I applies to every device. Chapter II is where applicability varies: a requirement about radiation or implantable materials only bites if your device involves those things. Chapter III applies to the labelling and instructions.
The GSPR checklist
The practical instrument is the GSPR checklist. For each of the 23 requirements, the checklist records:
- whether the requirement applies to your device;
- the solution you adopted to meet it, including any harmonised standard used;
- the objective evidence that demonstrates conformity; and
- a cross-reference to where that evidence sits in the technical documentation.
Two disciplines matter. Every applicable requirement needs evidence, not an assertion. And every requirement you mark not applicable needs a documented justification, because “not applicable” is a claim a notified body will test.
Why the GSPR checklist is the backbone
The GSPR checklist is not a side document. It is the spine of the whole conformity story:
- It structures the technical documentation, since each requirement points to the evidence that supports it.
- It is a core focus of the notified body assessment, which works through the checklist against the file.
- It underpins the EU declaration of conformity, the legal statement that the device meets the MDR.
A weak or generic GSPR checklist is one of the fastest ways to turn a technical documentation review into a list of findings. A precise one, with real evidence behind each applicable requirement, is what a clean assessment runs on.
Frequently asked questions
What are the General Safety and Performance Requirements?
They are the requirements in MDR Annex I that a device must meet to be safe and to perform as intended. There are 23, organised into general requirements, design and manufacture requirements, and requirements for the information supplied with the device.
Are the GSPRs the same as the old Essential Requirements?
They are the MDR successor to the Essential Requirements from the old Medical Device Directive, expanded and reorganised. The concept, a set of requirements you demonstrate conformity against, carries over; the content and structure changed.
Do all 23 GSPRs apply to every device?
No. The general requirements in Chapter I apply broadly, but the design-and-manufacture requirements in Chapter II depend on the device’s technology. Any requirement marked not applicable must carry a documented justification.
What is a GSPR checklist?
A structured table that, for each applicable requirement, records the solution adopted, the standards used, the objective evidence of conformity, and a cross-reference into the technical documentation. It is the backbone of the technical file.
Why does the GSPR checklist matter so much?
Because it structures the technical documentation, is a core focus of the notified body assessment, and underpins the EU declaration of conformity. A precise, evidence-backed checklist is what a clean assessment depends on.
Related guides and services
- Regulatory Affairs support from CENIT Consulting: building a GSPR checklist that maps each requirement to real evidence in the technical documentation.
- Quality management support: the risk management and evidence processes the GSPRs draw on.
For the short definition, see the GSPR glossary entry.
This article is for general information only and is not legal or regulatory advice. Teams remain responsible for regulatory decisions and staying current with applicable regulations and guidance.
Talk to CENIT Consulting about your GSPR checklist and technical documentation: book a 30-minute consult.