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 - SaMD

12-01-2018medicaldeviceslegal

An unsurprising case of software qualification with an interesting twist

The unsurprising software qualification case that I wrote about earlier turns out to still have a little twist in the judgment that the European Court of Justice (CJEU) recently rendered in that case. The CJEU went into details that the Advocate General (AG) had not gone into so in the end the judgment turned out […]

26-07-2016medicaldeviceslegal

Software MEDDEV updated

The Commission issued an updated version of the MEDDEV 2.1/6 regarding standalone software on 15 July. After all the rumors around the difficult discussions surrounding the revision process I was very curious about the changes finally implemented. Unfortunately these changes turned out to be very limited and in my view do not change the scope […]