CE marking

Article

Don’t give me Brexit problems, give me Brexit scenarios

At the moment I spend a considerable amount of my lawyering time answering questions concerning Brexit problems. My first question back to the company is: what are your Brexit scenarios? Did you make a plan to cover the scenarios and follow through? Often the answer is “no, we don’t have a plan, because we don’t […]

Article

Wearables Seminar Presentations

A lot of people turned up at this seminar on wearables and the regulatory, legal and commerical aspects. In case you were not able to make it, please find the presentations below:…

Article

The new Blue Guide is here

After a royal time of suspense, the new Blue Guide has finally arrived. Was it worth the wait and what is new and noteworthy in medical devices? Let’s see. I will take you…

Article

EU mHealth regulatory requirements and update: why the NO in innovation?

mHealth is one of the big promises worldwide to reduce costs of healthcare and empower patients. The challenges in mHealth are roughly the same in the EU and US: watch Rock Health’s…

Article

IMDRF Software as Medical Device definition document completes

In relative quiet the IMDRF has delivered its first deliverable in the series of documents relating to Software as a Medical Device (SaMD) on 18 December last year, together with a number…

Article

CE certification of standalone software and apps seminar – the movie

Rather than streaming our last medical technology seminar on CE Certification of Standalone Software and Apps of 16 October in real time (big hassle and very prone to tech glitches we’ve found), we…

Article

ENVI vote results out: we have a draft legislative resolution

The ENVI vote results that have already been hotly debated and opined upon are now finally out in the form of a draft European Parliament legislative resolution that the Parliament will vote…

Article

Surprise! Unannounced notified body audits Commission recommendation finally issued

While everybody in the medical devices industry is still reeling from the ENVI vote results (of which we still don’t know what they are in detail because the documents have not been…

Article

Healthcare software enforcement alert

If you are active in the medical software field in the Netherlands you may probably be aware already that the the Dutch healthcare Inspectorate IGZ has announced that it will rigorously enforce…

Navigate through our knowledgebase