Annex II and Annex III of the MDR provides a detailed list of information to be included in the Technical documentation of a medical device. The higher risk the device is, the higher level details the documentation shall provide. Our Regulatory experts are able to support manufacturers in drawing up the technical documentation with a structured approach tailored on the device characteristics
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Regulatory compliance
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MDR 2017/745 brought a series of important changes in the regulatory framework of medical devices, requiring a stricter premarket analysis, an increasing demand of evidences, both clinical and preclinical, updated risk classification system, addition of groups of products without an intended medical purpose.
Within this evolving regulatory framework it is crucial to understand whether the device still meet the requirements of the updated Regulations in order to keep the device “alive” and not interrupting the availability of devices in the market.
Classification of medical devices according to MDR
If a manufacturer is in doubt on how to properly classify his device, our experts can support in providing the appropriate rationale to justify the applicability of each classification rule laid down by the MDR. This will come to a classification proposal to be submitted to authorities.
Literature review supporting equivalence, claims and mechanism of action
The demonstration of equivalence and the generation of data through a structured literature review is a service to those manufacturers who would strengthen the rationale on the mechanism of action of the device. With years of experience in literature assessment and medical writing, we can support manufacturers to generate additional data for their justifications.
To get more information you can click the button below, you will be contacted by our experts as soon as possible.
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