LRQA Notified Body Lloyd’s Register Quality Assurance (LRQA) announced on June 13, 2019, that it will be withdrawing services relating to the Medical Devices Directive (93/42/EEC) (MDD) and the In-Vitro Diagnostic Devices Directive (98/79/EC) (IVDD) as well as its application to become a Netherlands-based EU Notified Body for the new…
The European Medicines Agency has approved approximately 50 out of 60 applications from drug companies applying for the temporary batch testing exemption. MA holders granted the exemption are provided with additional time to move their batch testing sites for centrally authorised products (CAPs) from the UK to the EU. Instead…
This post reproduces a client alert, available here. The current situation surrounding the UK’s departure from the EU remains uncertain. At present, following the European Council’s decision to grant the UK’s request for an extension for time, the UK is legally due to leave the EU on 12 April 2019.…
A high volume of guidance documents has been issued by the MHRA on a possible no deal scenario in the last week. Further to the previous no-deal guidance and draft legislation already published (and covered in this blog), the MHRA has in recent days published a huge raft of further…