General safety and performance requirements are the benchmark set out in Annex I of the Medical Device Regulation against which a product must demonstrate its conformity. They address not only the control of risks but also the performance claimed by the manufacturer for its intended purpose. The English abbreviation GSPR is frequently used in technical documentation.
Annex I as a requirements catalogue
The catalogue begins with general requirements for safety and performance and then lists specific requirements, for example concerning chemical, physical and biological properties, infection and microbial contamination, products with diagnostic or measuring functions, and labelling and instructions for use. Not every point applies to every product. The manufacturer must therefore first determine which requirements are relevant for the specific technology, intended purpose, user group and application environment.
Conformity is not demonstrated by simply ticking off a list. For each relevant requirement, the technical documentation must identify the method applied and the evidence. This may include risk management documentation, test reports, biological evaluations, software validations, usability data or clinical data. Non-applicable points require a traceable justification. The GSPR demonstration thus links individual evidence to the regulatory requirements for the product.
Clinical evaluation and performance demonstration
To confirm conformity with the relevant requirements, the MDR requires sufficient clinical evidence. The clinical evaluation examines whether the product is safe in its intended use and achieves the claimed clinical benefit. It is therefore not a separate scientific annex alongside the GSPR, but a supporting source for requirements concerning benefit-risk ratio, side effects and performance.
How much clinical evidence is sufficient must be justified by the manufacturer. Novelty, risk profile, intended purpose, available data and remaining knowledge gaps all play a role. For products already CE-marked, historical market presence alone does not constitute evidence. The evaluation must show how the relevant data support the respective requirements and whether clinical follow-up after placing on the market remains necessary.
Distinction from the essential requirements of the Directives
The former Medical Devices Directive used the term essential requirements. The MDR continues the catalogue as general safety and performance requirements, thereby making it explicit that the product must achieve not only safety but also the claimed performance. This addition is not a linguistic detail: a risk analysis without adequate demonstration of performance cannot fully establish MDR conformity.
The GSPR are also not to be equated with a harmonised standard. Standards may offer technical pathways to fulfil a requirement, but they do not replace the assessment of their applicability to the specific product. Nor does certification replace the manufacturer’s responsibility to justify and keep current the fulfilment of the relevant Annex I requirements in the technical documentation.
The GSPR table frequently functions as a navigation tool for the technical documentation. It can link the individual requirement, the applicability status, the relevant standard or specification, the evidence and the location. Its value lies not in the table format but in unambiguous traceability: an auditor or Notified Body must be able to move from the regulatory requirement to the test, evaluation or clinical evidence that supports it.
Relevance for clinical trials
A clinical investigation should be aligned with open requirements of the GSPR demonstration. Endpoints, comparator group, observation period and capture of adverse events must therefore match the claimed performance and the identified risk. If the data collected are later used for a clinical evaluation, the product version in the study must correspond to the subject of the conformity demonstration. Otherwise the evidence cannot be reliably transferred to the technical documentation.
Full-service CROs such as Mediconomics support the translation of open GSPR into clinical questions, the preparation of investigation plans and statistical concepts, and the assignment of study results to clinical evaluation reports. They can also verify whether safety endpoints, usability and performance parameters actually cover the claimed intended purpose.
If the product or its intended purpose changes, it must also be verified whether the assignment of requirements remains correct. New materials, an expanded user group or an additional software mode may require additional evidence.
Frequently Asked Questions (FAQ)
Do all requirements from Annex I apply to every medical device?
No. The manufacturer determines the relevant requirements for the respective product and justifies in the documentation why other points are not applicable.
Can a standard fully replace the GSPR?
No. A standard may represent a recognised technical demonstration pathway. The responsibility for the specific conformity assessment and for justifying applicability remains with the manufacturer.
What role do clinical data play in the GSPR demonstration?
They support in particular the evaluation of safety, clinical benefit, side effects and benefit-risk ratio. Their quantity and quality must match the product type and intended purpose.
Regulatory References
- Regulation (EU) 2017/745, Annex I – contains the general safety and performance requirements.
- Regulation (EU) 2017/745, Article 61 – links the confirmation of conformity to sufficient clinical evidence.
- Regulation (EU) 2017/745, Annex II – assigns the GSPR demonstration to the technical documentation.
- MDCG 2020-6 – explains clinical evidence for the demonstration of conformity for legacy devices.