Dear Business Partner,
The most significant change, that medical device manufacturers have to implement with respect to the MDR (EU 2017/745) is, that they must be able to provide clinical data on their products.
The availability of clinical data has gained considerable importance for both, new devices as well as legacy devices. Beyond safety and performance clinical data must address:
Clinical Benefits and Claims
According to the MDR "a detailed description of intended clinical benefit with relevant and specified clinical outcome parameters" is required. Manufacturers must take care, that all promotional materials are scrutinized for claims of clinical benefit. For printed and online material the company has to decide whether such claims can be confirmed; otherwise these claims for clinical benefit should be removed.
We support your decision making process, considering the marketing needs and regulatory environment. Therefore, different sources of data are worth to consider, including but not limited to:
- clinical investigations
- survey from health care professionals
- survey from patients/users
- case reports
- retrospective data
- market surveillances
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