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Quality Control & Compliance

Set Alert for Quality Control

Optimizing EU Medtech Regulatory Governance And Innovation: First Workshop Shapes Future Study

Work related to the European Commission’s promise to assess the impact of the Medical Device Regulation, including its impact on innovation, is starting to take shape.

Europe EU

Exciting New Opportunities Launched In UK For Innovative Products As IDAP Gets Underway

Medtech developers have just over a month to apply for the pilot phase of a program offering regulatory and practical support to accelerate innovative product access to the UK NHS.

Europe United Kingdom

Entire EU Medtech Industry Throws Weight Behind Argument To Structurally Reform MDR And IVDR

The European Commission has conceded to the medtech industry’s calls to delay and modify the new EU regulatory requirements multiple times over the last few years. But will it yield to fresh calls for radical changes being sought by the most powerful lobby yet?

Europe EU

Finland’s Eurofins Becomes EU’s 11th Notified Body Designated Under the IVDR

The number of notified bodies designated under the IVD Regulation has now crept up to 11 as the first Finnish designation is announced.

EU Europe

FDA Finalizes Voluntary Improvement Program Guidance Document

The US FDA has finalized a guidance document on the Voluntary Improvement Program, which aims to help manufacturers continuously improve quality and compliance.

Regulation Compliance

Taking Steps Towards Improving Innovation Opportunities In The EU Regulatory Environment

The German notified body, TÜV SÜD, is looking to help create a more favorable regulatory environment for medtech innovation within the EU as the debate continues over damaging MDR/IVDR implementation practices.

Europe EU

FDA Issues Guidance On Biocompatibility Testing For Devices That Make Contact With The Human Body

The US FDA has issued final guidance to assist developers in preparing various applications for medical devices that come in contact with the human body. The guidance also seeks to clarify the use of international standards in assessing device biocompatibility.

FDA Guidance Documents

Top Ten August: Perceived Failures Linked To MDR/IVDR Implementation Result In Fresh Calls To Action

It is no secret that that the implementation of the EU’s Medical Device and IVD Regulations has been problematic. Now, despite most processes and documents being in place, experts are making fresh warnings and calling for radical changes.  

Europe EU

How Well Is The Commission Communicating On MDR And IVDR? Have Your Say!

The European Commission has launched a 16-question survey giving the overwhelmed medtech sector a chance say what MDR and IVDR information tit needs and how stakeholders want to receive it.

EU Europe

Medtronic HVAD Woes Continue

Medtronic has identified additional HeartWare Ventricular Assist Device pumps that the company says have a higher risk of failure than average for the devices.

FDA Cardiology

One More IVDR Notified Body In The Wings As Designation Progress Continues To Advance

Every designation of a notified body under the Medical Device and IVD Regulations has been greeted with fanfare given the historic pressure for more testing capacity. There may have been a shift in timelines, but IVD manufacturers still urgently need to engage with a certified testing body.

Europe EU

Should The EU Establish A Central Accountable Managing Structure For Medical Devices?

Top regulatory experts are reacting to German industry calls for action over MDR/IVDR failures, including a proposal to have a centralized governance agency modeled on the European Medicines Agency but specifically for devices.  

Medical Device In Vitro Diagnostics

MDR Flowchart Explains When Legacy Devices Can Benefit From Extended Timelines

Are you uncertain whether your medtech products can benefit from transition period extensions that feature in the March 2023 amending Regulation to the MDR? The latest European Commission document offers help.

Europe EU

FDA Sends Warning Letter To Integra Following Recall Of Surgical Repair Products

After an inspection of its Boston facility, the US FDA issued a warning letter to Integra LifeSciences' subsidiary TEI Biosciences for distributing collagen-based medical devices that failed bacterial endotoxin tests and did not conform to good manufacturing practices.

FDA Warning Letters

Supreme Court Decision Makes Partnerships With International Manufacturers More Crucial For US Firms

Supreme Court finds presumption against extraterritorial reach of US laws, saying Congress never “affirmatively and unmistakably instructed” Lanham Act provisions apply to foreign conduct. Contracting with manufacturers abroad is potential pitfall for protecting trademarks, along with licensing brands to foreign marketers.

Consumer Legal Issues

Recalls For Datascope And Abiomed Designated Class I

The US FDA has updated a recall of Datascope Cardiosave IABPs to reflect its class I high-risk status and announced a recall of the labeling for Abiomed’s Impella RP Flex. 

Recalls FDA
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