Ensuring Your Medical Device Is Both Safe and Effective

Oct 8, 2019 | Product Development, Quality + Regulatory

It’s a major part of getting your medical device approved. It’s also vital to show that your device is safe and effective in use.

Clinical Evaluation requirements have become larger and more complex, with the advent of the Medical Device Regulation in Europe.

Getting all this wrong is damaging. It’s extremely time consuming. It’s very expensive.


If you had a sense of what you needed to do, to take care of this, what would you then do?

After watching this video, you may want to think about how you’ll put what you learn into action.


In this bite-size video, we’ll continue our exploration of the map of medical device development. This time, we’re taking a look at the Clinical track.


It’s an overview of the steps you’ll need to take to

  • Explore the science that supports or challenges your innovation
  • Identify gaps in existing research
  • Plug those gaps with appropriate Clinical studies

In the time available to us, we can’t go into great detail, so please get in touch to find out more.


Our journey starts with

Clinical Planning. Setting out the broad brushstrokes of activities that you’ll need to do, to ensure your development project addresses the requirements of regulations (particularly the Medical Device Regulation) and ISO 14155 for Clinical Investigation.

At this stage, you’ll probably get started with Literature Research too, so you have a clear picture of any gaps in research that you may need to plug later on.


Clinical Design sets out the details of your plan for Clinical Investigations that are required to plug the gaps you’ve identified.

You will need to ensure that you plan for regulatory authority and ethics approval of your Clinical study(ies), as well as their set up, execution, analysis and reporting.


During the Development phase, you execute your planned Clinical Programme, which may include a number of Investigations, across several countries – all designed to answer the scientific questions required to demonstrate your product’s clinical safety and efficacy.

This stop will take longer than you expect, so it’s vital to get started early with identifying study centres, study investigators, talking with regulatory authorities and initiating Ethical Review.


The results of your Clinical Programme are typically reported during the Industrialisation phase of development, leading to the production of a Clinical Evaluation report.

This documents the fruits of your Clinical Evaluation, the Investigations undertaken and how their results support the safety and efficacy of your medical device. As I mentioned earlier, you’ll be taking care to ensure that the Medical Device Regulation requirements for Clinical Evaluation are comprehensively covered.

There’s a close link here with Risk Management reporting, particularly to support the verification of risk mitigations.


A significant aspect of your Post-Market Surveillance activities will be the planning, execution and reporting of Clinical Follow-up studies. These will typically look at things like;

  • Safety and performance of the device
  • Previously unknown side effects
  • Emerging risks
  • Acceptability of the Benefit/Risk conclusion


As you watched this video, you’ll have started to think about how you can go about addressing each of these steps properly, making the best of each part of your journey. You may now want to get some guidance to turn your thoughts into concrete actions.


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