Common specifications are technical or clinical requirements established by the European Commission for specific medical devices or in vitro diagnostics. They define legal obligations in more detail when harmonized standards are missing, do not sufficiently fulfill their purpose, or when public health concerns require a uniform solution.
Function in European Product Law
The regulations on medical devices and in vitro diagnostics allow the Commission to adopt common specifications. These can specify requirements for performance evaluation, clinical evaluation, safety, or post-market follow-up procedures. Unlike a general description of the state of the art, such requirements are directed at clearly defined product groups or configurations.
For in vitro diagnostics, the Commission explains that full or partial compliance with the covered common specifications triggers a presumption of conformity. This effect only applies to the specific requirements regulated; it replaces neither the technical documentation nor the performance evaluation as a whole. Manufacturers must therefore determine whether a specification is relevant to their intended purpose, the analyte, and the intended user group.
Distinction from Harmonized Standards
A harmonized standard remains a voluntary way to demonstrate compliance with relevant legal requirements. In contrast, common specifications have a mandatory starting point: deviation from them is only permitted if the chosen solution demonstrably ensures at least an equivalent level of safety and performance.
The deviation is therefore not a mere reference to an internal work instruction or another standard. It requires a product-related justification stating which requirement is fulfilled differently, how equivalence is proven, and which data support the claimed safety and performance. This difference determines the scope of the assessment, particularly when a harmonized standard exists but is insufficient for the specific technology.
Impact on Assessment and Documentation
In the case of a relevant specification, the technical documentation should map the individual requirements to a requirements matrix. For an IVD, requirements for performance studies, reference materials, or the type of clinical evidence may be relevant. A conformity assessment can only traceably verify whether the chosen evidence strategy covers every relevant requirement.
If the manufacturer decides on an alternative solution, the comparative logic belongs in the risk and performance argumentation. This includes the justification for the deviation, the limits of transferable data, and the acceptance criteria for the alternative method. A subsequent change to the common specification may also trigger a re-examination of the product documentation.
Common specifications do not originate as a manufacturer’s internal interpretation. Their subject matter and scope are established EU-wide. This creates a common basis for comparison for manufacturers, notified bodies, and competent authorities, particularly for high-risk or public health topics. For affected products, not only the text of the specification is important, but also the temporal scope of the respective implementing regulation.
In practical implementation, a separate consideration of each requirement is recommended: Which product variant is covered, which evidence method does the requirement demand, and which section of the technical documentation does it affect? This makes it clear whether an existing test report actually covers the specification or merely examines a similar characteristic. The presumption of conformity can only be based on a clearly assigned and fully documented application.
Common specifications are thus neither an additional voluntary source of information nor a blanket claim of quality. For their regulated area, they prescribe how legal requirements can be specifically met. For IVDs, they may concern the expected design of the performance evaluation. Testing their applicability therefore belongs at the beginning of the regulatory strategy, not just at the end of the technical documentation.
Relevance for clinical trials
In performance studies with IVDs, common specifications already influence the planning of evidence: they can determine which performance aspects must be investigated and which data sources must be used. Study documents should therefore be checked before submission to ensure they actually reflect the specified endpoints, comparative methods, or evidence. An unrecognized specification can lead to inquiries because the clinical investigation plan and performance evaluation diverge.
Full-service CROs like Mediconomics support manufacturers in transferring relevant specifications into a requirements matrix, adapting the performance study to the resulting evidence needs, and consistently documenting justifications for deviations with medical writing, biostatistics, and regulatory affairs.
Frequently Asked Questions (FAQ)
Do common specifications only apply to in vitro diagnostics?
No. The Commission can adopt them under both the MDR and IVDR; however, their practical significance depends on the specific product group and requirement being regulated.
Does compliance with a common specification replace the clinical or performance evaluation?
No. It can establish a presumption of conformity for the points it covers, while the overall evaluation must still consolidate all relevant data.
Is every deviation from a common specification impermissible?
An alternative solution is possible if it is properly justified and achieves at least an equivalent level of safety and performance.
Regulatory References
- Regulation (EU) 2017/746 (IVDR) — forms the basis for common specifications for IVDs.
- MDCG 2022-2, Guidance on clinical evidence for IVDs — explains the presumption of conformity and the alternative solution.
- MDCG 2021-5 Rev. 1, Guidance on standardisation — defines the role of standardization and specifications.
- Implementing Regulation (EU) 2022/1107 — contains common specifications for certain IVDs.
