Medtech Insight

Interview: ‘More Forward Thinking’ Needed For UK IVD Industry As Brexit Looms

Incoming head of diagnostic regulation at the UK ABHI Steve Lee makes a plea for more detailed MHRA guidance around product registration requirements for the post-EU national market.

Topic Medtech-Brexit Regulation

Medtech Insight

Not Too Late? German Industry Presses For EU MRA With Post-Brexit UK

BVMed says the EU and the UK should set up a system of mutual recognition of medical device regulation to kick in when the UK’s EU exit transition period ends on 31 December. 

Topic Medtech-Brexit Regulation Brexit

Medtech Insight

UK Updates Medtech Industry On National Regulatory System Progress

The UK will have new regulatory systems for medical devices in place for when it leaves the EU at the end of this year. The Office for Life Sciences has been fielding more questions from industry on the new structures.

Topic Medtech-Brexit Regulation Brexit

Medtech Insight

The Politics And The Practice Of UK Standalone Devices Regulation

Taylor Wessing partner Alison Dennis and MHRA devices regulatory policy manager Gavia Taan provide updates on the UK’s device regulatory plans after the Brexit transition period ends.

Topic Medtech-Brexit Regulation Brexit

Medtech Insight

UK Updates Medtech Industry On National Regulatory System Progress

The UK will have new regulatory systems for medical devices in place for when it leaves the EU at the end of this year. The Office for Life Sciences has been fielding more questions from industry on the new structures.

Topic Medtech-Brexit Regulation Brexit

Medtech Insight

As Expected, FDA Misses Fourth Consecutive Deadline For Releasing Draft QSR

The US FDA’s internal deadline of October 2020 for putting out a draft of its retooled Quality System Regulation is the fourth it failed to meet. The agency has been harmonizing its decades-old QSR with ISO 13485:2016 for more than two years.

Topic Regulation

Pink Sheet

England's HTA Body To Revamp Product Selection Processes

Proposals from NICE now under consultation are intended to boost the health technology assessment body’s efficiency, improve transparency and governance, and raise the quality of its guidance

Topic Regulation EU

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

Pink Sheet

Biopharma, the White House And Getting Drug Pricing 'Off The Table'

Industry balks at President Trump’s latest effort to force biopharma to negotiate a drug pricing solution, but investors may be pushing for concessions that could head off more onerous policies supported by a Biden White House.

Topic US Election 2020 Drug Pricing Regulation