Medical devices

The European market is attractive for medical device manufacturers. However, manufacturers should be aware that it is a moving target. Substantial changes have been recently introduced in the European regulatory framework for medical devices and further change is expected in the upcoming years. Concurrently, national health authorities, facing rising health costs, tend to grow more fussy about reimbursement issues. These trends translate into a greater demand of clinical evidence of device performance and safety. While many see this as a burden it is also an opportunity for innovators to make their product stand out from the rest and obtain rewarding reimbursement rates. The aim of this site is to present, in a set of brief and practical documents, the European context and to explain how ClinSearch can help you to choose and implement the best strategy for a successful marketing in Europe.

Our services for your devices

ClinSearch is committed to helping you market your device in Europe and obtain a fair reimbursement by performing any necessary clinical evaluation or investigation.

• Counselling on clinical evaluation strategy
• Bibliographic review and meta-analysis
• Analysis, reporting and publishing of existing data
• Controlled clinical trials
• Observational studies: cohorts and registries
• Diagnostic accuracy studies
• Medico-economic evaluations

Top five reasons to perform clinical evaluation

1. In the new European regulatory framework for medical devices, some sort of clinical evaluation is required for the registration of new devices.
2. Your device is innovative and you believe this results in a tangible benefit for patients. Demonstrating it by an appropriately designed clinical investigation will allow you to obtain a higher price or reimbursement.
3. Should your device raise a safety issue, you will learn it early enough to take corrective action. You will thus avoid damage to your company’s reputation by a paper in a medical journal or worse, in the news, and lawsuits that may altogether be fatal to your business.
4. If, on the other hand, your device is safe, by documenting this safety you will be in position to counter unwarranted claims of harm.
5. By allowing selected investigators to experiment with your device and to contribute to a good scientific paper you will raise the level of trust of these physicians and their readers in your product.

Further reading

• The European regulatory framework

Selected links

• The European Commission portal for medical devices In a new window
• Global Harmonization Task Force (GHTF) In a new window
• Asian Harmonization Working Party In a new window
• Eucomed In a new window — European medical technology association
• Advamed In a new window — US medical technology association