Blog Post
URGENT: Actions to take before Brexit for medical device manufacturers
As we edge nearer to a potential exit of the UK from EU on 29th March 2019 without the UK parliament having agreed to a deal with the UK, the probability of the UK leaving the EU without a deal grows ever greater. If this occurs, there will be no cushion of a transition period for medical device manufacturers.
Blog Post
GDPR compliance in clinical trials
What should be the basis for processing of data in clinical trials? The approach recommended by the HRA for UK trials is unlikely to work in all EU27, but we hope that the new EDPB guidance will set out an EU-wide approach - as we explain in this article.
Blog Post
Opaque CJEU ruling threatens future of gene editing in the EU: CRISPR-Cas9 organisms are subject to rigid controls of GMO Directive
The Court of Justice of the European Union (CJEU) has ruled that organisms created using modern gene editing tools – including CRISPR Cas-9 - should be subject to the same stiff regulation as genetically modified organisms (GMOs).
Blog Post
MDR / IVDR Transitional Regime: Timing is All!
It is less than 2 years before MDR and 4 years before IVDR become fully applicable, and medical devices manufacturers requiring notified body certification for CE marking should assess their regulatory position urgently to avoid the situation of not being able to sell their devices in the EU.
Blog Post
Brexit – How is it looking for Life Sciences Companies?
The UK government has this week published four reports indicating that market access for UK life sciences companies will not change during the Brexit implementation period of 29 March 2019 to 31 December 2020. So why are various pharmaceutical companies announcing plans to stockpile drugs in preparation for Brexit?
Blog Post
Select Committee report on medicines, medical devices and substances of human origins
Last week the House of Commons Select Committee published its report on the impact Brexit may have on medicines, medical devices and substances of human origins, advocating very close regulatory alignment. You can read more on the report, its conclusions, and what life sciences companies need to do to prepare, on our Brexit blog.
Blog Post
Fieldfisher Life Sciences Team Recognised in Legal 500
The extensive Fieldfisher life sciences team has been ranked once again by the Legal 500 and many team members recognised for the specialist client advice.
Blog Post
UK and overseas companies in the frame: two new corporate criminal offences in force as of 30 September 2017. What is the Criminal Finances Act 2017 and how should Life Science companies react?
Guidance for Life Science companies on the Criminal Finances Act, outlining various risk situations that might arise in business activities and noting items to think about in preparing to be compliant with the Act.
Blog Post
Update – implications of the Nagoya Protocol on microbial inventions
By way of update to our previous article entitled Microbial Monopolies, we consider the importance of the Nagoya Protocol when conducting research which may involve the transfer of microbes across international borders.
Blog Post
Brexit and the regulation in the Life Sciences sector: Where is it all heading?
The UK Life Sciences industry is waiting to see the Government's plans for product and other regulation: -will we go for a "soft" Brexit, largely following and harmonising with EU laws, or a "hard" Brexit, looking at a completely sovereign system: a British solution?