medicaldeviceslegal

Festive alert! Change is on its way.

Change is on its way – medical devices law will not be the same again as of next year. Panic soccer The authorities are not your friend anymore. Notified bodies are engaging in massive ‘panic soccer’ (Dutch expression) dropping companies like they’re hot. If you have not implemented the new clinical evaluation MEDDEV fully by […]

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 […]