It is more important than ever that medical device manufacturers planning to enter the European market, place new medical devices on the market, or maintain the CE mark during transition to the forthcoming MDR, 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 suitable for review by the Notified Body, can help alleviate these doubts. Such a document can 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.
We are aware that some Notified Bodies are no longer willing 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; however, they should be willing to review a clinical strategy document. This is because it provides general information on a company’s plans for demonstrating adequate clinical evidence and should not include details such as the clinical study protocol, which a Notified Body will need to evaluate as part of its conformity assessment activities.
In some cases, a clinical strategy document may provide a justification for device ‘equivalence’, which will allow the clinical data of an different device of the same type to be used to demonstrate clinical safety and performance of the device in question. In other cases, it may provide a justification for the use of existing clinical data and/or plans for future studies for demonstrating clinical safety and performance.
If a manufacturer plans to market its medical device in the EU and the US, it may be necessary to determine how clinical data requirements for both jurisdictions can be met, to avoid unnecessary duplication of work and costs.
DLC 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
DLC has the knowledge and experience to assist you in the development of effective medical device, IVD and combination product regulatory, clinical study, and quality system strategies, so that important project milestones within planned timelines can be met. Contact us either by e-mail for a confidential discussion about your project, or call Dr. Maria Donawa, President, on +39 06 578 2665.