General Safety and Performance Requirement (GSPR)
Device-specific GSPR checklists built for EU MDR and ready for Notified Body review.
Regulatory Expertise
In-depth knowledge of EU MDR and the global regulatory landscape.
Practical Compliance Support
Actionable solutions tailored to your product and business needs.
Documentation Guidance
Clear, structured and audit-ready documentation support.
Market Access
Smooth and safe access to the European market.
What is GSPR?
GSPR are the essential safety and performance requirements that a medical device must meet under the MDR. Under Article 5(2), a device must meet the GSPR that applies to it, taking its intended purpose into account. They replaced the Essential Requirements of the Medical Device Directive (93/42/EEC) and are significantly more detailed. They add requirements on software, cybersecurity, substances of concern, lay users and information supplied with the device.
The General Safety and Performance Requirements (GSPR) in Annex I of Regulation (EU) 2017/745, the EU Medical Device Regulation (EU MDR), set out what every medical device must achieve before it can carry the CE mark. Each applicable requirement needs a method of conformity, the standards applied and a traceable reference to objective evidence in your technical documentation. As an MDR consultant, 3i Concept helps medical device and drug-device combination product manufacturers build GSPR checklists that stand up to Notified Body review.
Services
- Technical Services For Design And Development Of Medical Devices
- QMS Development and Support
- Risk Management Service
- Technical Documentation Services
- Medical Device Labelling
- Audit Readiness Plan
- Design Control Requirements for Drug-Device Combination Products
- EU Medical Device Regulation
- Medical Device Testing Service
How Annex I is Structured
The MDR contains 23 GSPR, arranged in three chapters:
Chapter I – General Requirements (GSPR 1–9)
Safety and performance, risk management, risk reduction as far as possible, use error, device lifetime, transport and storage, and benefit-risk acceptability.
Chapter II – Design and Manufacture (GSPR 10–22)
Chemical, physical and biological properties, infection and microbial contamination, devices incorporating medicinal substances, materials of biological origin and interaction with the environment, measuring functions
Chapter III – Information Supplied with the Device (GSPR 23)
Requirements for the label, sterile packaging and Instructions for Use.
Where GSPR Sits in Your Technical Documentation
Annex II, Section 4 of the MDR requires your technical documentation to show:
Which GSPR apply, and a justification for each requirement that does not.
The method used to demonstrate conformity with each applicable requirement.
The harmonised standards, common specifications or other solutions applied.
The precise identity of the controlled documents that provide the evidence.
GSPR for Drug-Device Combination Products
Combination products are where GSPR work gets most complex, and where 3i Concept’s experience is most relevant:
- Devices incorporating a medicinal substance (GSPR 12.1): the quality, safety and usefulness of the substance must be verified by analogy with the methods of Directive 2001/83/EC. The Notified Body must also seek a scientific opinion from a medicines authority.
- Devices composed of substances absorbed by the body (GSPR 12.2): these carry additional requirements covering absorption, distribution, metabolism and excretion, interactions and toxicity.
- Integral products regulated as medicines (Article 117): for prefilled syringes, pen injectors and auto-injectors placed on the market as medicinal products, the marketing authorisation application must show that the device part meets the relevant GSPR. If the device part is not CE marked, this is done through a Notified Body Opinion.
- Substances of concern (GSPR 10.4): drug delivery components often contain plasticisers or other substances that trigger justification requirements above 0.1% w/w.
For pharmaceutical companies, this means GSPR compliance under the MDR is no longer only a device manufacturer’s concern.
Common GSPR Challenges
Manufacturers most often run into:
- Checklists carried over from MDD Essential Requirements without re-mapping to the expanded MDR requirements.
- Generic “not applicable” statements with no device-specific justification.
- Evidence references that point to whole reports rather than the specific controlled document and section.
- Outdated standard versions that do not match the current harmonised list or the state of the art.
- A disconnect between the GSPR checklist, risk management file and clinical evaluation, which Notified Bodies check for consistency.
- Missing coverage of newer requirements, such as software and IT security (GSPR 17) and lay user protection (GSPR 22).
Our GSPR Services
At 3i Concept, we support manufacturers through every stage of MDR GSPR compliance:
- GSPR Checklist Preparation: building a complete, device-specific checklist from scratch.
- Applicability and Justification Review: determining which requirements apply and writing defensible justifications for those that do not.
- Standards Selection: identifying the harmonised standards, common specifications and state-of-the-art references that fit your device.
- Evidence Mapping and Gap Analysis: linking each requirement to controlled documents and identifying the testing or documentation still needed.
- MDD to MDR Transition: converting Essential Requirements checklists for legacy devices.
- Combination Product Support: GSPR 12 compliance and device documentation for Article 117 Notified Body Opinions.
- Alignment with Risk Management and Testing: making sure your GSPR checklist, ISO 14971 risk file and test reports tell one consistent story.
Subhash Meena
Medical Device & Drug-Device Combination Product Expert
Why Choose 3i Concept
Our GSPR work is led by Subhash Meena, a medical device and drug-device combination product expert with 15+ years of experience. He has worked across Meril Life Sciences, Sun Pharmaceutical Industries, Amneal Pharmaceuticals and Dr. Reddy’s Laboratories. His experience with pen injectors, auto-injectors and prefilled syringes, along with direct Notified Body filing experience, means your GSPR checklist is prepared by someone who has seen how it is reviewed.
15+
Year of Experience
4
Leading Companies
NB + USFDA
Direct Fillings
Frequently Asked Questions
GSPR are the safety and performance requirements in Annex I of the MDR that every device must meet, as applicable to its intended purpose, before CE marking.
There are 23, grouped into three chapters: general requirements, design and manufacture, and information supplied with the device. The IVDR has its own set of 20.
The MDR does not require a specific format. However, Annex II requires you to document applicability, methods of conformity, standards applied and evidence for every GSPR. A checklist is the standard way to present this, and Notified Bodies expect one.
Essential Requirements applied under the old MDD. GSPR replaced them under the MDR and are more detailed, adding requirements on substances of concern, software, cybersecurity, lay users and labelling.
Yes, if they market integral drug-device combination products as medicines. Under Article 117, the device part must meet the relevant MDR GSPR, which is demonstrated through a CE certificate or a Notified Body Opinion.
Harmonised standards give a presumption of conformity only for the requirements they cover. Any gaps must still be addressed through other means.
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