Clinical Evaluations for Medical Devices and IVDs
How should industry be preparing for the EU MDR clinical changes?
Read the regulation and the supportive medical device coordination group guidance documents to understand the expectations. Forget your old strategical steps and think in a different way addressing the new requirements.
What is “sufficient” clinical evidence?
The answer depends on whether the device is a legacy device which is well-established, a legacy device which is not well-established, or a totally new device. In general, you need clinical evidence justifying your claims and the benefit risk profile of the device when used as intended.
What are the data expectations for clinical evidence in both the US and EU?
Both jurisdictions are getting comparable, but the expectations in Europe with regard to some devices are getting even higher than in the US.
What lessons have you learnt so far in getting EU MDR ready?
Your initial understanding of the legal obligations may be wrong. Continuous education and exchange with subject matter experts are necessary to keep up-to-date.
What are the key factors in developing a strategic outlook on Clinical Evaluation Plans?
Get a clear picture of key stages in your devices development and lifecycle, define key performance indicators and work towards them. A lot of people plan their lives in 5 year chunks. Why not do the same for your device?
What are the best ways to future proof a CER for long-term strategy?
I do not think there is a future proof strategy. The success of your CER depends on your data. If you start neglecting them with time, even the best strategy will not help.
I think it is important to have a clear idea what kind of data is appropriate for your device. Do a gap analysis, involve others, like marketing, sales, and product management and work together to find ways of acquiring the data you need.
The devil is in the detail. Never think you’ve worked it all out, as you will sooner or later come across a tiny detail that forces you to re-think everything. Do not get comfortable, keep asking questions, stay alert and stay agile.
