Blog Post
Healthtech on the NHS?
In March 2019, NICE published revised Evidence Standards Framework for Digital Health Technologies for businesses aiming to supply the NHS. The updated version includes greater guidance and more examples to help applicants, however possibly still not enough detail to build a business plan around it.
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Medical Device Manufacturers: BEWARE FAKE NEWS!
At some point, which could be 11pm BST on Friday 12th April, or perhaps a later date if the UK PM obtains her "short" extension, the UK could still fall over the Brexit "cliff edge" and lands with a bump, or perhaps a boom, of a no-deal/ hard Brexit. In anticipation of such an event, what should medical device manufacturers do?
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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.
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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.
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Medical device manufacturers' emergency preparation for Brexit
If you are a manufacturer of medical devices which you sell into the European Union (EU) and your notified body for EC Certificates of Conformity is still in the UK, and you want to sell your devices in EU27: you need to act now!
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Can I have an SPC for my drug-device combination?
Spoiler alert: No, you can’t, says the CJEU in its ruling on C-527/17 (Boston Scientific)
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PMCPA Code – can pharmaceutical companies be responsible for the actions of their corporate parent?
Pharmaceutical companies rarely operate in one country, and are normally supported by an international parent company and numerous subsidiary companies around the globe. However, a parent company in another country may not appreciate the regulatory responsibilities in the UK, and may cause problems for the UK subsidiary.
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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?