The Alliance of European Life Sciences boutique Law Firms is an alliance of independent European life sciences boutique firms from around Europe, active in all areas of life sciences and medical technology.

The Alliance was founded in 2011 and consists presently of eight law firms, uniting a unique team of lawyers with many years of experience as external and in-house counsel in a large variety of areas the life sciences industry.

Please see the contact page for more information.

Category - enforcement

15-12-2016medicaldeviceslegal

The authorities are not your friend anymore; and neither are notified bodies

With the MDR and IVDR adoption in sight (currently scheduled for Q1 2017) I see a number of developments in the market, all converging on the higher standards that will be imposed under these new regulations. By way of update, there is movement in the dossiers of the MDR and IVDR. The first drafts of the translations […]

09-09-2013medicaldeviceslegal

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 medical devices law against medical software that they consider a medical device as of 1 January 2014. They have said so pretty clearly […]