It is more important than ever that medical device manufacturers planning to place new medical devices on the EU market determine the adequacy of the clinical data they have generated, or plan to generate, in support of CE marking to the MDR.
Where doubts exist regarding the adequacy of clinical data, the development of a clinical strategy document may help alleviate these doubts. Such a document may also help prevent rejection of the clinical evidence upon which device clinical safety and performance claims are based, either by the Notified Body or a Competent Authority conducting market surveillance of CE marking documentation.
Notified Bodies are no longer allowed to review certain CE marking-related documents, such as clinical study protocols or CER drafts, outside of the formal technical documentation review process, to avoid an appearance of providing consultancy. They may be willing, however, to review a clinical strategy document, for example under the structured dialogue process. This is because it provides general information on a company’s plans for demonstrating adequate clinical evidence. It may also provide a justification for the use of existing clinical data and/or plans for future studies for demonstrating clinical safety and performance.
In some cases, a clinical strategy document may provide a justification for the use of clinical data from an ‘equivalent’ device to demonstrate safety and clinical performance of the device in question.
If a manufacturer plans to market its medical device in the EU and the US, it is critically important to determine how clinical data requirements for both jurisdictions can be met, to avoid unnecessary duplication of work and costs.
Donawa Lifescience can help you to:
- Understand EU clinical data expectations
- Develop a clinical strategy for meeting EU clinical data requirements
- Develop a clinical strategy document for presentation to a Notified Body, for internal use, or for investors
- Determine how EU and US clinical data requirements can be met, avoiding, where possible, a duplication of work and resource expenditure
