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9 Steps to right first time regulatory compliance

24th July 2018

By Medilink member, Three Circles

It can be a scary thought, regulatory compliance. So much to get your head around, so much to make sure is done right, and what is “right” anyway.

Wouldn’t it be handy to have a “crib sheet” to help you get there with less pain, in a shorter time, whilst simultaneously supporting development of a good medical device.

1. The right regulation?

May sound a bizarre first step, yet it is surprising just how many projects don’t adequately consider this question.

  • Be clear about the primary purpose for your medical device, and the mode of action.
  • Then, check the definition of “medical device” in the MDD (Article 1, 2 (a) through to (c)).
  • Does your product fit the description of a medical device? If, yes, then the MDD applies.
  • Does your product fit the description of an in vitro diagnostic device? If yes, then the IVD applies.
  • Does your product clearly not fit with any of the descriptions?  You can get advice (in the UK) from MHRA on borderline cases.  Similarly, you can access EU wide borderline device decisions, and the reasoning.

Remember to also consider other EU legislation that your product may need to comply with.  And, if you have an eye on other markets, look at how their requirements may differ from those of the EU.

2. Are you setting out to solve the right problem?

What is the problem or clinical need that your product is intended to resolve?  Is the problem widespread or isolated to a small aspect of healthcare in one country?

Answering this question will clarify the potential market size and clinical pathway(s) where the device can be used.  Your focus is then narrowed onto developing a product to address a specific need.  You can always expand into other clinical pathways or markets with a future version of the product.

Ultimately, you’ll have started to flesh out the product’s “Intended Use”, the bedrock upon which development rests.  Get this right, and the foundation is secure.

3. Put a Quality Management System in place

Arrival of the Medical Devices Regulation (MDR) explicitly requires a Quality Management System to be put in place for all classes of Medical Device.

The difference between the lowest risk medical devices and the higher classes is one of QMS certification.  For the Class 1, non-measuring, non-sterile medical devices, a manufacturer self-certified QMS is perfectly fine.  Otherwise, a Notified Body certification is needed.  Make sure you adopt the correct QMS certification route for your device.

4. Good Development Practice

“Begin with the end in mind” as Steven Covey said.  As you develop your device, picture how the documentation will come together for the submitted device.

The Design History File and Risk Management activities will tell the story of development, demonstrating why and how you arrived at the eventual solution.

The Technical File will provide the complete dossier of information that describes the medical device manufacture, assembly, testing and release requirements.

Robust, applied Documentation Control and Change Control ensure that you minimise the opportunity for surprises popping up at the end of development.  Start Change Control at an early stage in development, so design decisions are captured and can be referred to easily when answering regulatory authority questions on the submission.

Traceability Matrices should be your (new) best friend – they’re invaluable in ensuring that you’ve covered all the bases during planning, designing, testing and reporting.  If they’re created as you go along, headaches will be smaller than if gaps are spotted when the matrix is created at the end of development.  You may even consider a matrix for the Essential Requirements, to ensure you have documented evidence of compliance with each one.

Find out how you can get in touch with Three Circles today and explore how best to ensure you reach your goal of regulatory compliance, right first time. Read the full article here.

9 Steps to right first time regulatory compliance

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