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Set Alert for Policy and Regulation - Europe

US, UK And Canada Collaborate On Transparency Principles For Devices Using Machine Learning

The principles urge device makers to look at the whos, whys and whats of device use in developing their data transparency approaches.

FDA Regulation

Why Notified Bodies Are Now The Focus Of Centralized Oversight Efforts

Proposals for substantial changes to oversight of medtech notified bodies are likely to be part of the European Commission’s targeted evaluation of the MDR and IVDR, EU medtech lawyer, Erik Vollebregt, tells Medtech Insight.

Europe EU

Deloitte Tackles Pros and Cons of Europe For Medtech

A new report commissioned by trade group MedTech Europe finds that while EU medtech businesses benefit from some government support and a strong talent pool, they continue to lag in attracting investors and face mounting regulatory challenges.

Europe Market Intelligence

Oliver Bisazza Warns That EU’s Innovation Issues May Create More Reliance On Medtech Imports

Innovation has been hindered in the EU by the costs and complexities of compliance, including in the medtech sector. Bisazza looks at how high-level, multi-sectoral moves are underway to create a more innovation-friendly environment.

EU Europe

Amendment To MDR May Be First Legislative Proposal Of New European Commission

How Germany, which has the EU’s largest medtech manufacturing base, is pressing for the MDR to feature on the mission letter for the new European Commission and could influence the pace of change.

EU Europe

European IVD Industry On Rocky Road; Veer Toward 'Pockets of Growth'

Despite challenges and projected European decline, the in vitro diagnostics market has enticing "pockets for growth" post-pandemic, industry leaders revealed at the MedTech Forum conference. Key drivers include healthcare decentralization and consumer pull for control over health. Opportunities exist in neurology, oncology, and direct-to-consumer testing.

Europe EU

Europe Must Take Temperature Of New EU Institutions Before Next Medtech Initiative

MedTech Europe's Oliver Bisazza reflects on how European election outcomes may influence medtech regulatory strategy

Europe EU

Global Medtech Guidance Tracker: May 2024

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Sixty-five documents have been posted on the tracker since its last update.

International Guidance Documents

How The European Parliament Seeks To Amend The MDR: A Step-By-Step Guide

Medtech Insight has already focused on six of the key changes in the parliament’s proposal to the European Commission. This article looks in further depth and breadth at the changes which, if taken up, are designed to ease the regulatory burden in the EU, support SMEs and innovation. and result in fewer products being removed from the market.

Europe EU

Feedback Sought On Managing Conflicts of Interest Under EU HTA Regulation

Representatives and individual experts taking part in joint assessments of new health technologies need to be free from conflicts of interest in relation to the industrial sector in which the health technology developer operates.

Europe Health Technology Assessment

MDR/IVDR Amending Document Finally Adopted

In this amendment to both the Medical Device and IVD Regulations, the IVD Regulation timelines will be eased and Eudamed will be rolled out before the entire database is ready.

Europe EU

Surprise EU Document Emerges With Proposal For European Medical Device Office

Industry will be well acquainted with the proposal's content since it reflects its own work on the much-needed further development of the Medical Device Regulation

EU Europe

MedTech Forum: EU’s Regulatory Priorities To Soon Be Solidified So Medtech Must Engage Now

The MedTech Forum looked at why industry should see the outcome of European Parliament elections as an opportunity to help drive through much-needed change.

Europe EU

France Consults On Best Practice Guidelines For Decentralized Trials

The CNIL plans to update its data protection methodologies based mostly on the results of a new consultation and the outcome of a pilot in which companies are asked to identify the challenges they have faced when designing trials with decentralized elements.

Clinical Trials Guidance Documents

European Parliament Proposes Radical Changes For The Recertification Of Medical Devices

Just as concerns are growing in the sector about how notified bodies will manage simultaneous surges in requests for recertification and legacy devices around 2027/28, the European Parliament has launched a key initiative.

Regulation Policy

EMA Answers More Questions For Manufacturers of Drug-Device Combos

Will it be necessary to provide a new medical device notified body opinion when changes are being made to the medicine in an integral drug-device combination product? This is just one of the new topics addressed in an updated Q&A document from the European Medicines Agency.

Europe Approvals
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