Strategy for Regulatory Compliance MDR

A regulatory strategy is not only for the regulatory department.

A few weeks ago, I made a post around Notified Body strategy and the cost of compliance. The Strategy for Regulatory Compliance is a requirement that has came very specifically as a result of MDR and IVDR.

This then begs the question, what should be the scope of the strategy for regulatory compliance?

Further, should a manufacturer limit this scope of this to purely EU? Or, since the QMS can produce the output, is it worth expanding this out to other regulatory jurisdictions as best practice?

Furthemore, is it also worth covering things such as competent authority / UKAB / NB strategy and defining the intended certification structure around the device and QMS?

As usual, the answer is - it depends. I hope one day I can write something without using the words - IT DEPENDS...

If we're designing a brand new device, I always want the the regulatory strategy shall encompass all of the above for all of the regions it wants to cover. Considering the certification structure will also enable the manufacturer to be able to ensure it is designed in the most cost-effective and efficient way possible. Like a Risk Management Plan, it should be a living document, that evolves as the business begins to understand the requirements of the NB. While we're here - a great thing to consider in the regulatory strategy may be the costs of NBs, which were shared by the EC Commission, here is the link for it - https://lnkd.in/ePFyfNKq

It can also contain elements relating to the Person Responsible for Regulatory Compliance (PRRC EU MDR) in line with Article 15 of Regulation 2017 / 745. It is imperative to have a PRRC medical device representative.

The reason I think the regulatory strategy is so important is that it should provide key input to the management team around the entirety and plans for that device lifecycle. It should keep all key stakeholders in the business in the loop and provide an understandable summary.

Feel free to reach out if you would like to discuss any online regulatory affairs courses or medical device consultancy.