As we say in Dutch: the day that you knew that would come is finally here. The legislative proposal to grant the Healthcare Inspectorate (IGZ) IGZ enforcement powers in the field of industry/HCP interactions (the “Wet van 17 mei 2017 tot wijziging van wetgeving op het terrein van de zorg in verband met het invoeren […]
Normally one looks back at the end of the year, but I also like to look ahead because there are a lot of developments in EU law that will affect the medical devices industry next year: new rules on cybersecurity, data protection, mHealth and business compliance will put their mark on 2016, additional to the never-ending […]
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 the blog, with an overview of the developments discussed in it. Can’t ask what can’t be offered 2014 was the year in which […]
This spring holiday I took the recently published Study on Corruption in the Healthcare Sector with me as holiday reading and that proved a good choice. The 332 pages long study was commissioned by the European Commission (EC) Directorate-General Home Affairs and involved cooperation between Ecorys, the European Healthcare Fraud & Corruption Network (EHFCN) and individual country […]
No one is an island, and neither is my firm. We have the honor to cooperate with the excellent Italian law firm Italy Legal Focus in the Alliance of European Life Sciences Law Firms, which includes boutique life sciences firms from France, Germany, Italy, the Netherlands and the UK. Paola Sangiovanni from Italy Legal Focus […]
Last week I attended the Eucomed Compliance Committee meeting in Brussels, and presented on some of the compliance developments going on in the Netherlands with respect to medical devices. Just like all other member states, the Netherlands had to play their part in executing the Joint Immediate Action Plan. Also, they have some ideas of […]