General Safety and Performance Requirements
General Safety and Performance Requirements
The European Union (EU) regulation of in vitro diagnostic medical devices (IVDs) is centered on granting market access to IVDs that offer clinical benefit while ensuring the safety of patients, users, and others involved in their use. To achieve this, the regulation sets requirements that ensure a high level of health and safety protection is fulfilled wherever applicable.
Previously, under the EU IVD Directive 98/79/EC, manufacturers were required to adhere to the essential requirements (ERs).
With the introduction of the new EU IVD Regulation 746/2017, these requirements have been expanded. Now, manufacturers must demonstrate compliance with the General Safety and Performance Requirements (GSPRs). The GSPRs encompass broad, high- level criteria for safety and performance throughout the entire lifecycle of all IVDs, encompassing design, production, and post-production aspects.
Manufacturers who previously complied with the Directive must ensure that their IVDs remain in conformity with the new legislation.
Overview of the GSPRs:
The GSPRs are grouped into three main chapters within Annex I of the EU IVDR: Chapter I
General Requirements (GSPRs 1 to 8): These apply to all IVDs and cover their intended performance, safety, and health protection.
Chapter II
Requirements Regarding Performance, Design, and Manufacture (GSPRs 10 to 19): This chapter focuses on specific aspects of IVDs, such as their performance characteristics, construction, and protection against various risks.
Chapter III
Requirements Regarding Information Supplied with the Device: This chapter primarily deals with labels and instructions for use, including general requirements and specific information.
Manufacturer’s Responsibilities Regarding GSPRs:
Manufacturers must identify and justify all relevant GSPRs for their devices. The risk classification of the IVD does not influence the choice of GSPRs. It is crucial to have a quality management system (QMS) mechanism to identify and monitor compliance with applicable GSPRs, ensuring the most appropriate means are used to fulfill each relevant requirement.
Ways to Demonstrate Conformity with the GSPRs:
Manufacturers can demonstrate conformity with the GSPRs through various means, such as documented risk analysis, clinical evidence, literature searches, expert opinions, relevant certifications, and more. Using harmonized standards or common specifications, when available, can also help demonstrate compliance.
Priority in Cases of Dual Classification:
If an IVD is also classified as machinery under Directive 2006/42/EC, the manufacturer must comply with both the specific health and safety requirements of the machinery Directive and the general safety and performance requirements of the EU IVDR. Health Institution Exemption and GSPRs:
In the case of a health institution exemption, the relevant GSPRs must still be complied with, even though all other requirements of the IVDR are exempt, provided that the IVD is used solely within the institution and all specified conditions are met.
Conclusion:
Compliance with the GSPRs under the EU IVDR is crucial for manufacturers of IVDs to ensure market access and the safety of their products. It is essential to constantly review and update the evidence supporting each GSPR, considering advancements in technology and medicine. With the right approach and evidence, manufacturers can successfully meet the GSPRs and ensure their IVDs’ safety and efficacy in the European market. IVDRconsulting is available to offer assistance and expertise in meeting the GSPRs effectively.