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Quality Control & Compliance

Set Alert for Quality Control

Mid-May MDCG Mandate Madness: Pre-empting Questions On Investigator Brochures

Newly issued EU guidance documents make it easier for device companies to draft clinical investigation brochures that will pass authority inspection. They also give insight into what notified body designating authorities check for.

Europe EU

BSI First Notified Body To Officially Publish Lead Times Under EU Medtech Regulations

BSI says it has no capacity restrictions under the Medical Device Regulation or the IVD Regulation and can start the technical documentation review for the majority of product categories within a month from submission.

Europe EU

EU Medical Professions Call For Immediate Measures To Prevent Device Shortages

Their concerns overlap with those of the medtech products industry when it comes to how patients will be impacted unless critical action is taken to improve the EU's Medical Device Regulation.

EU Europe

EU Announces Fifth MDR Notified Body Designation In Five Weeks

The latest EU organization to be named under the Medical Device Regulation is based in Austria.

Europe EU

Notified Body Numbers Continue To Shoot Upwards As Turkey Gains Third Certification Body

The designations of notified bodies are coming fast and furious, with four announcements in a month.

Europe EU

US FDA Clearance For Masimo’s Stork Delivers OTC Baby Monitoring Tech Competition

Masimo receives US regulatory clearance for Stork OTC baby monitoring system six months after Owlet received first clearance for its Dream Sock following a regulatory stumble which halted sales of a previous device, Smart Sock, in 2021.

Approvals OTC Devices
Europe EU

News We’re Watching: Philips Settles Recall Fallout; FDA REdI, Townhalls, Approvals

This week, Philips Respironics reached a $1.1b settlement affecting CPAP and other breathing devices. Toku announced it received US FDA breakthrough device designation for its MyKidneyAI technology. This May, the FDA will hold its REdI conference focusing on innovation in medical product development and hold another townhall focusing on considerations for selecting a sterilization modality.

News We're Watching FDA

UK MHRA’s Strategic Approach To AI Will Be ‘Proportionate’ And Fit Well Internationally

UK pursues light-touch regulation as it forges ahead with its own approach to regulating AI but with one eye on international convergence.

Europe EU

Attorney: Proposed Data Privacy Law Would Ultimately Reduce Regulatory Burden

Data privacy lawyer says the comprehensive, bipartisan law is “catching a lot of people’s ears.”

Policy Compliance

EU Regulatory Roundup, April 2024: EU On Cusp Of Regulatory Shifts Amidst Political Change

There are new EU regulations on medtech’s horizon following votes this month by the European Parliament. There are also unknowns when it comes to future leadership and the direction it will take as industry advocates for much-needed change.

Europe EU

It’s Official: FDA Drops Final Rule On LDTs

After much anticipation, the US FDA is set to publish its controversial final rule for regulating laboratory developed tests, which places the tests under the same regulatory purview as other in vitro diagnostics. While the agency opted to include an exemption for LDTs already on the market, it did not provide an exemption for tests developed in academic medical centers.

FDA In Vitro Diagnostics

Valuable Health Data Sources For Medtech Industry Come A Step Closer In The EU

The only step that remains now before the  European Health Data Space Regulation is approved is sign off by the Council of the EU, due next month. Industry wants to see the new framework carefully aligned with existing EU legilsation.

Europe EU

EU: Good News For IVDs And For Future Transparency Of Medtech Compliance

The IVD industry has long been awaiting a further extension of the deadlines for compliance with the IVD Regulation and for the launch date of the Eudamed database to be brought forward.

Europe EU

EU Experts Want One-Stop-Shop EU Governance That Mimics Best Of Other Jurisdictions

It may be blue sky thinking to surmise how a new EU medtech regulatory governance structure could evolve. But with change on the horizon, experts see exciting opportunities.

EU Europe

MAISI: Navigating The 'Valley Of Death' In Medtech Research Translation

Translating research from proof of concept to clinical investigations is a difficult hurdle to overcome. To succeed, researchers need to design their technology for industrial standard manufacturing early on, Anne Vanhoestenberghe, director for the Manufacture of Active Implants and Surgical Instruments (MAISI), told Medtech Insight.

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