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.

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Category - bottleneck

20-03-2020medicaldeviceslegal

The MDR and the Covid-19 recommendation – a possible template for fixing the MDR and IVDR bottleneck

What is this recommendation about? Obviously this recommendation is an attempt of the Commission to manage administative barriers to placing PPE (personal protective equipment) and medical devices on the market that would be needed in the struggle to get the current Covid-19 pandemic under control. In my view you can also see this as a […]

13-06-2019medicaldeviceslegal

Bottleneck of bottlenecks for notified body capacity

People that are downplaying the notified body bottleneck may need to start to revisit their position with notified body LRQA now also dropping out of the notified body pool for medical devices and IVDs. This is especially a problem with respect to IVDs, as LRQA is one of the notified bodies traditionally handling a large […]