Category - CE marking

medicaldeviceslegal

More on placing on the market

After my blog about guidance document MDCG 2021-27 in which I argued why in my view it defines placing on the market wrongly by requiring transfer of a property right as a condition for placing on the market, a lot of discussion started. I even received an email from the European Commission commenting on the […]

medicaldeviceslegal

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 […]

medicaldeviceslegal

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 through this substantial document in a number of blogs, of which this is the first. Some history But first, for those who are […]

medicaldeviceslegal

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 Halle Tecco’s speech in the Stanford Technology Ventures Program identifies systemic challenges facing healthcare in America and shares examples of companies working to address these […]

medicaldeviceslegal

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 of other documents, after it was adopted at the meeting n Brussels 12-14 November 2013. People that commented on the document will remember that  the […]

medicaldeviceslegal

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 on on 22 October. Now we can be sure what’s in the text, we can say something about details that are usually lost […]