Updates on Legal Developments in the EU Life Sciences Industry
On 20 March 2020, the European Medicines Agency (EMA) published Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic (the Guidance). The EMA jointly developed the Guidance with working groups from the European Commission and the national Heads of Medicines Agency (HMA).
The Guidance provides information on…
Continue Reading EMA Publishes Guidance on Clinical Trial Conduct During COVID-19 Pandemic
The Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a specification for a “Rapidly Manufactured Ventilator System” (“RMVS”), setting out the clinical requirements for a ‘minimally acceptable’ ventilator for use in hospitals during the COVID-19 outbreak (the “RMVS Specification”). The purpose of the RMVS Specification is to meet the…
Continue Reading MHRA issues specification for a “Rapidly Manufactured Ventilator System” for use in hospitals during the COVID-19 outbreak
On 26 February, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) published further guidance (available here) setting out the anticipated regulation of medical devices in the UK, should the UK leave the EU without a deal (Guidance). This Guidance will apply from ‘exit day’ (expected to be 11 p.m. 29 March 2019) subject to the (currently draft) Medical Devices (Amendment) (EU Exit) Regulations 2019 (UK MDR 2019) (available here) being passed by UK Parliament. This latest Guidance follows on from the MHRA’s previous ‘no deal’ scenario further guidance note in January regarding medicines, medical devices and clinical trials regulation (available here).
The Medical Devices Regulations 2002 (UK MDR 2002) implement Directives 90/385/EEC, 93/42/EEC and 98/79/EC on active implantable medical devices, medical devices, and in vitro diagnostic medical devices (IVDs), respectively (EU Directives) into UK law. Pursuant to the European Union (Withdrawal) Act 2018, the UK MDR 2002 will continue to apply.Continue Reading UK regulator provides further ‘no deal’ Brexit guidance for medical devices regulation
This post was originally published on our sister blog Inside Medical Devices.
On 18 July 2014, the Medicines and Healthcare Products Regulatory Agency (MHRA) announced that it will create a new independent Devices Expert Advisory Committee (DEAC) before April 2015.
The DEAC will be responsible for providing independent expert advice to help the MHRA regulate medical devices. The MHRA hopes that the DEAC will help the MHRA “have stronger links with the wider scientific community to facilitate access to specialist expertise.” The DEAC is expected to be relatively small in size with around 12 members and a chair to enable the group to be more agile and responsive to important regulatory issues concerning medical devices.
Continue Reading MHRA Creates New Expert Advisory Group on Medical Devices
