The MDR 2017/745 does restrict the use of equivalence to existing devices, sometimes referred to as predicate devices. Read here what you need to know.
Why equivalence is interesting?
Equivalvence to an existing medical device allows a legal manufacturer to manufacturer of a medical device to use the technical documentation, post market surveillance (PMS), possible post market clinical follow up (PMCF) and the scientific literature used for the clinical evaluation of an already marketed device. With this, a major part of time- and cost- consuming work for clinical investigations can be avoided. The equivalence approach, thus, can add a major benefit to a fast-to-market approach for a medical device.
Equivalence to an own product
To use the equivalence approach, the easiest way is to prove equivalence to an own product. For own products, the prerequisite documents are certainly available within the company. Thus, equivalence to an own product can readily be shown and proven.
Equivalence to a third party product
To use the equivalence route, or sometimes referred to as substantial equivalence, the technical documentation must be accessible. For risk class IIb implants, implantable devices and risk class III medical devices, a contract must be in place which regulates the access to the technical documentation.
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What you have to show in any case
With access to the technical documentation, a manufacturer needs to show equivalence in regard to technical, biological, and clinical characteristics and properties. With this, no significant difference in the safety and clinical performance, summarized in the general safety and performance requirements (GSPR), should be detected to claim equivalence.
Another often made mistake is to claim equivalence to more than one medical device. This, in fact, is not possible as equivalence can only be claimed to a single product.
Class I, IIa, IIb
Implantables, Class III
prove gspr equivalence
How Avanti Europe can help
Avanti Europe’s Experts have a decade-long track record and expertise in consulting and hands-on work in product development, Quality Assurance and Reqgulatory Affairs. Our experts support your company with hands-on workforce and support in equivalence assessment, risk-based process design, documentation, and training for the company staff. Visit our online shop for checklists and other services.