Category - Software

medicaldeviceslegal

An unsurprising case of software qualification

First: my apologies for the collapsed frequency of articles on this blog – I’m very very busy, literally day and night, with questions about any and all aspects of the MDR and the IVDR. The summer is a bit more quiet so you can expect more content again. Intermezzo on software under MDR and GDPR […]

medicaldeviceslegal

Privacy by design and data portability

I’ve often warned medical devices companies that they need to start looking at privacy by design obligations under the General Data Protection Regulation, the GDPR. Engineers at a company where I gave an in-company presentation earlier this year were seriously unhappy that privacy by design obligations can affect both hard and software and that the […]

medicaldeviceslegal

The MDR – where are we now?

There seem to be a lot of misunderstandings in the market about the current status of the MDR. Some think it’s finished (it’s not, at least not formally) and there is a lot of insecurity about when it will enter into force. Currently the MDR and IVDR are in the process of translation. The trilogue […]

medicaldeviceslegal

Software MEDDEV updated

The Commission issued an updated version of the MEDDEV 2.1/6 regarding standalone software on 15 July. After all the rumors around the difficult discussions surrounding the revision process I was very curious about the changes finally implemented. Unfortunately these changes turned out to be very limited and in my view do not change the scope […]

medicaldeviceslegal

Counting down to the final text of MDR and IVDR; more on software

It’s the final countdown! Following the trilogue’s agreement on the MDR and IVDR texts the Commission (DG Growth) confirmed at the eHealth Week in Amsterdam last Friday that (probably late) this Wednesday the agreed text of the MDR (and, I assume, IVDR too) will be made public as the signatures required will finally have been […]

medicaldeviceslegal

Wearables – a seminar about legal and regulatory aspects

Wearables are getting more and more popular and start to move more into the healthcare field by tracking all kinds of data concerning physiological processes and performance. Some companies explicitly want their wearables to be medical devices, others prefer their wearables to stay out of that.  Some companies plan their data protection compliance for personal data […]

medicaldeviceslegal

In, on and near body networks EU regulation

I had the pleasure of being invited to speak at the Health IT forum at the MEDICA conference last week on regulation of in, on and near body networks. Most of my day at the MEDICA I spent in the health IT hall, catching up on developments, particularly in the interesting Wearable Technology Pavillion with […]

medicaldeviceslegal

Surprise! More on unannounced audits, this time on software

Further to my recent posts on unannounced audits I have been thinking about how unannounced audits could play out in an area that becomes more and more important: standalone software. Software medical devices The majority of standalone software under the medical devices directive falls in the scope of rule 12 of Annex IX of the MDD […]