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 - Class I

18-03-2020medicaldeviceslegal

New MDCG Class I Article 120 (3) and (4) MDR guidance – nothing new but nice summary of requirements

I have blogged before about the effects and possibilities of the Corrigendum of December 2019 for class I medical devices. I refer you to that blog for the background to this discussion, which covers the mechanics of timing. The draft corrigendum discussed in that blog was adopted as described. The new guidance The MDCG has […]

09-12-2019medicaldeviceslegal

Corrigendum 2 and the (potential) consequences for class I devices

Everybody has been in enormous suspense about how the second corrigendum to the MDR and IVDR would turn out. The version that came out of the European Parliament’s ENVI committee vote contains a number of very technical points that I will not elaborate on. But it also contains the big break for certain class I […]