Clinical & Regulatory

Clinical & Regulatory

Software qualification


Intermezzo on software under MDR and GDPR

While everybody should be beavering away on the implementation of the MDR and IVDR or overcoming their inertia do so ASAP, still some interesting things happen in the mean time. If your company is in software as medical device, there is even more reason to do so because of the MDR changes the classification rules for software as medical device dramatically, expands the scope of the concept of accessory (which enlarges the scope of software regulation) and includes a whole chapter on software design requirements.

And then there is the new General Data Protection Regulation that your software needs to be compliant with by 25 May 2018 – less than a year, that’s right. How long is your company’s software development cycle? See my presentation at the Personal Connected Health Alliance in May this year below for a very brief overview of MDR and GDPR compliance requirements coming your way very fast:

This article first appeared on Medical Devices Legal and was written by Erik Vollebregt. You can read the full article here.

About Medical Devices Legal

Medical Devices Legal is a medtech legal and regulatory blog written by Erik Vollebregt. Erik is a founding partner of the boutique life sciences law firm Axon Lawyers, specialised in EU legal and regulatory issues relating to medical technology.

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