,
Erik Vollebregt
The UK Medicines and Healthcare products Regulatory Agency has issued guidance on how medical devices manufacturers can provide an electronic format of their instructions for use (eIFU). However, the guidance has come…
,
Karin Verzijden
Securing proteins from alternative sources than meat or fish is nowadays a topic in the centre of the debate. The Dutch Vegetarian Butcher has found a solution for this challenge by manufacturing…
,
Erik Vollebregt
New combination products are being developed to fulfil unmet medical needs but the regulations are taking time to catch up. Shayestey Fürst-Ladani and Lindsay Kostadinov report from a conference where drug and…
,
Erik Vollebregt
On 13 January I presented the yearly complaince update for the Netherlands to the Medtech Europe Compliance Network in Brussels. Since the presentation is no secret know-how, I thought I’d share it on…
,
Erik Vollebregt
Because we see a huge increase in interest in regulation of 3D printing and biofabrication (which I have blogged and taught about), my firm decided to organise a seminar about it. As…
,
Karin Verzijden
Further developments in Brussels took place since we last reported on the new Novel Foods Regulation. Draft legislation was approved in this respect by the ENVI Committee, awaiting the first reading of…
,
Erik Vollebregt
In a previous post I promised more on cybersecurity, so here it is. Spoiler alert: the conclusion of this post is that cyber security requirements for medical devices in Europe are currently…
,
Erik Vollebregt
So, it took a while but the devices have finally landed. During the EPSCO council of 1 December it was confirmed that the medical devices policy has indeed moved to DG ENTR….