CERES GmbH evaluation & research
__How to Address Clinical Benefit and Claims?
     
Claim or not to Claim?

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
  • registries
  • survey from health care professionals
  • survey from patients/users
  • case reports
  • retrospective data
  • market surveillances
  • literature

Looking for an Experienced CRO for Medical Devices?

Your device and your needs should be in focus of the trials you perform. Don't become an experiment of your service provider. In about 15 years CERES quality of service confirmed
  • experiences
  • efficiency
  • reliability
Our goal oriented capabilities aren't limited to "copy & paste" of regulatory documents. Our targeted communication with clinical affairs, R&D, regulatory affairs and further stakeholders ensures coverage of the whole clinical product lifecycle according to your needs.

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CERES_ShortProfile.pdf
     
 

CERES GmbH evaluation & research
Brombacher Str. 85, 79539 Lörrach, Germany


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