,
Erik Vollebregt
The European Commisison has opened a consultation on 28 March on the revision of the Transparency Directive, the EU directive that regulates certain formalities with regard to reimbursement of medicinal products in…
,
Erik Vollebregt
The DIA Euromeeting in Geneva was an excellent opportunity to meet a number of the regulators involved in the process of the Recast of the EU medical devices directives. Since a lot…
,
Erik Vollebregt
Advertising and promotion of medical devices are not harmonised under the EU medical devices directive, resulting in a fragmented legal landscape that differs from one EU member state to the other. To…
,
Erik Vollebregt
Today the Court of Justice of the EU delivered its much awaited opinion about the compatibility of the envisaged European and EU patent court with the EU treaties, as requested by the…
,
Erik Vollebregt
Some time ago I wrote about issues often overlooked in medical devices M&A transactions. Because of the reactions to it I decided to organise a seminar at my law firm’s Amsterdam office…
,
Erik Vollebregt
On Tuesday 22 February I delivered this presentation at the Q1 2nd Annual European Medical Devices Reimbursement Conference. My presentation addressed the question of what constraints there are on companies providing information…
,
Erik Vollebregt
It’s not breaking news anymore, but important anyway as this dossier is moving: the EU Parliament approved going forward with the singlish EU patent (singlish because not all EU member states are…
,
Erik Vollebregt
Medicaldeviceslegal is proud to report its first sent in medical devices judgment, kindly sent in by James Lawford Davies from the UK life sciences law firm Lawford Davies Denoon. Many thanks James,…
,
Erik Vollebregt
ISO 14155, who in medical devices is not familiar with that standard with respect to clinical investigation of medical devices for human subjects? Not that long after the EU had harmonised the…