Medtech Insight

EU Faces MDR Failure Unless It Adjusts To COVID-19 Crisis And Grows Notified Bodies

Is the current pandemic too big a hurdle for the EU’s medtech regulators and industry alike? What else might hold EU medtech back from the successful implementation of the MDR?

Topic EU Policy & Regulation

Medtech Insight

COVID-19 Has Prompted An 18-Fold Increase In German IVDs Production Capacity

How coronavirus affects IVDs businesses depends on the branch of the industry they are in, a German survey of manufacturers shows. German labs performed one million COVID-19 tests last week.

Topic Coronavirus EU Policy & Regulation

Pink Sheet

EU Pharma Strategy To Balance Innovation Incentives and Competition

Delegates at this week’s TOPRA conference heard the European Commission’s “holistic” vision of what it would like to achieve through its pharmaceutical strategy, including incentives for innovation, security of the supply chain, product shortages, real world evidence and big data, and the availability and affordability of medicines.

Topic EU Artificial Intelligence Regulation

HBW Insight

Nestlé To Enter Europe's CBD Market With UK Launch

Nestlé Health Science is expanding its CBD offering outside the US with the UK launch of a dietary supplement formulated by cannabis development firm Geocann.

Topic Consumer EU

Pink Sheet

Germany Sets Direction Of Travel With New Biosimilar Guidelines

Germany is for the first time to adopt national guidelines on prescribing biologics and biosimilars in move towards increasing biosimilar uptake.

Topic EU Biosimilars

Pink Sheet

UK Explains Approach To Renewing Converted EU Drug Approvals in 2021

The Medicines and Healthcare products Regulatory Agency has put procedures in place to renew UK marketing authorizations that are grandfathered from the EU system after the Brexit transition period ends.

Topic EU Pharma-Brexit Brexit

Medtech Insight

All About Value – Brexit Aside, UK Industry Sees Good Things Ahead For Healthtech Adoption

ABHI director of value and access Luella Trickett talks about the importance of real-world evidence in product development and value-based procurement in secondary care in the UK.

Topic Medtech-Brexit EU Legislation Regulation

Medtech Insight

Medtechs’ View Of UK Brexit Deal: More Certainty, But Still No Detail

COVID-19 is of no lesser importance to the UK medtech industry, but attention is now refocusing on Brexit, future regulation and trade deals.

Topic EU Medtech-Brexit

Medtech Insight

UK Readies Medtech And Pharma Sectors For Regulatory Life Outside The EU

Work has started on UK-only regulations for the medtech and medicines sectors, to ensure that the regulatory framework not only functions but can also react swiftly to needs after the UK leaves the EU. This article is part two of two.

Topic EU Medtech-Brexit Regulation Brexit