On 22 February 2022, the U.S. Food and Drug Administration (FDA or the Agency) announced that it was issuing a proposed rule to align the Agency’s current Good Manufacturing Practice (GMP) requirements for medical devices, codified at 21 C.F.R. Part
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Brexit update: Supply of Medicines from Great Britain to Northern Ireland
As we have previously reported, under the Northern Ireland Protocol of the Withdrawal Agreement between the EU and UK, Northern Ireland (“NI”) has continued to follow the EU rules after the end of the transitional period. In contrast, Great…
New EU Regulation Reinforcing the Role of the EMA
On 31 January 2022, Regulation (EU) 2022/123 on a reinforced role for the European Medicines Agency (“EMA”) in crisis preparedness and management for medicinal products and medical devices was published in the Official Journal of the EU. This Regulation sets…
EU Clinical Trials Regulation: Today is the Day!
The long awaited EU Clinical Trials Regulation applies from today, 31 January 2022.…
Update on the MDR and IVDR in the EU
A lot has been happening in the world of medical devices over the last few months – we set out some key points below.
Progressive roll-out of the IVDR
As discussed in our previous blog, the European Commission published…
Ten International Guiding Principles on Good Machine Learning in Medical Devices
The UK’s Medicines and Healthcare products Regulatory Authority (MHRA), the US Food and Drug Administration (FDA) and Health Canada have recently published a joint statement identifying ten guiding principles to help inform the development of Good Machine Learning Practice (GMLP). …
FDA Guidance on Clinical Investigators Signing Form FDA 1572 and Practical Challenges Outside the US
In May 2021, the U.S. Food and Drug Administration (FDA) published a draft guidance (Draft Guidance) addressing the requirement for all investigators involved in clinical trials conducted under a U.S. Investigational New Drug (IND) application to sign Form FDA 1572.…
European Commission proposal to delay application of In Vitro Diagnostics Regulation
European Commission launches consultation on reform of EU pharmaceutical legislation
On 28 September 2021, the European Commission took another step in the implementation of its new pharmaceutical strategy (discussed in more detail in our previous blog posts on the strategy, proposed amendments to orphan and paediatric legislation and…