Medilink

Do you know how the amendments to the Medical Device Directive will affect the gathering and use of your clinical evidence, and what your business needs to do to comply?

Find the answers at our regulations and guidance breakfast briefing, which is supported by Yorkshire Forward and Medvance:
Amendments to the Medical Device Directive – Providing Sufficient Clinical Evidence

From 2010 revised legislation will more specifically define what clinical data is required; and what companies are expected to do to ensure the safety and performance of their devices.

At present it is possible to cite the clinical data for a similar product to support CE marking, the revisions to the directive will require more substantial data. Given these revisions, companies will be performing more of their own clinical investigations to demonstrate compliance, particularly for novel or high-risk products.

In association with Medvance and Yorkshire Forward, Medilink are pleased to invite you to this breakfast briefing, which will provide guidance on how to gather the right clinical evidence to see your product through the regulatory, reimbursement and post market phases and determine what clinical evidence you need, when and how to obtain it.

The breakfast briefing will also include a case study;
Implementing new clinical requirements: Industry implementation Case Study.

This will cover: 

• The impact of the revision on the clinical department at company X
• What processes have had to change?
• The challenges of implementation
• How company X has gone about obtaining the relevant clinical evidence to support new product launches
• Will the changes impact speed to market? 
•  PMCF (post market clinical follow up)

To book your free place, please contact Nikola