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Policy & Regulation

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US FDA Advisory Panel Backs Claret’s Sentinel TAVR Filter

The panelists said the agency should approve the filter, which is used to protect the brain during transcatheter aortic heart-valve replacement surgery, despite ongoing questions about its effectiveness.

Cardiology Advisory Committees Medical Device

EU Industry Says Real Work Starts Now On Regulations

Industry recognizes considerable work has been done on cleaning up the texts of EU's future Medical Device and IVD Regulations. But it emphasized that further work is needed in the implementation phase to bring legal certainty and clarification.

Regulation Medical Device Europe
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Regulation

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Russian Medtech Industry Wants Quicker Progress On Eurasian Bloc Plans – 2017 Now Targeted

The much-anticipated Eurasian Economic Union (EAEU) was originally targeted to come into effect at the start of 2016, but more than year later, the five-member trading bloc has yet to be ratified by all nations. The Russian medtech industry is impatient for progress, but IMEDA's Sergey Kolosov sees some promising signs in recent developments.

Russian Federation Regulation Medical Device

Latest From Regulation

New EU Regulations: Guide To Latest – Likely Final – Texts

Why are there so many more pages and articles in the latest, likely final, versions of the Medical Devices Regulation and the IVD Regulation compared to the 2016 versions? What do these changes mean for the regulations, which are due to be adopted imminently?

Regulation Medical Device

More Tweaking Of EU Regulations ‘Unlikely’ As Latest Texts Are Issued

The Council of the European Union published the latest versions of the Medical Device and IVD Regulations, and the timelines to full implementation are now clearer.

Europe Regulation

Class I Recall on Zimmer Biomet Shoulder Replacement

The recall involves 3,662 artificial shoulders manufactured between 2008 and 2011, which have a higher fracture risk than depicted in labeling.

Orthopedics Recalls

Warning Letter Roundup & Recap – Feb. 21, 2017

No device-related warning letters were released by US FDA the week of Feb. 21.

Device Warning Letters Regulation

EU Notified Bodies Prepare For En Masse Redesignation

Members of the TEAM-NB association, which account for about half of the anticipated future force of EU medtech notified bodies, are taking a coordinated approach to applying for redesignations against the new EU Medical Device and IVD Regulations. Will they succeed?

Regulation Europe

Unannounced Audits In EU Not Obligatory, Commission Confirms

Will notified bodies be let off the hook when it comes to unannounced audits now that it is official they are not mandatory? And what is the role of national courts in notified body liability?

Compliance Europe
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Quality Control

Set Alert for Quality Control

Compliance 360° Part 4: How To Better Manage Your Quality Data

This is Compliance 360°, an eight-part podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this fourth installment, former FDA investigations branch director Ricki Chase explains how your firm can better manage its quality data.

Quality Control Compliance Quality

Latest From Quality Control

EU Notified Bodies Prepare For En Masse Redesignation

Members of the TEAM-NB association, which account for about half of the anticipated future force of EU medtech notified bodies, are taking a coordinated approach to applying for redesignations against the new EU Medical Device and IVD Regulations. Will they succeed?

Regulation Europe

Compliance 360° Part 3: Building Trust With US FDA – Can It Be Done?

This is Compliance 360°, an eight-part podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this third installment, former FDA investigations branch director Ricki Chase explains how your firm can build trust with agency investigators during a facility inspection.

Quality Control Compliance

New Bill Aims To Bring Consistency, Transparency To US FDA Inspections

US Sens. Johnny Isakson, R-Ga., and Michael Bennet, D-Colo., introduced legislation that calls for adopting a uniform FDA inspection process to ensure parity between audits of foreign and domestic device firms, notifying manufacturers in advance of records that will be requested during an inspection, and specifying a window of time for investigators to conduct their onsite inspections, among other requirements.

Regulation Policy

Unusual False-Claims Settlement Cites GMP Issues

A recent Baxter settlement over moldy air filters shows a move for DOJ to enforce manufacturing quality violations as part of its False Claims Act activities.

Compliance Legal Issues

More Manufacturers Sign Up For Single Audits As MDSAP Becomes Operational

A growing number of medtech manufacturers have expressed interest in the Medical Device Single Audit Program since MDSAP became fully operational in January. The program has also drawn interest from regulatory agencies beyond those from the five participating countries, and a policy is being framed to admit new members.

Quality Control Compliance

Q4 Recalls Snapshot: Numbers Dip Slightly But Remain High; Sterility Troubles Bubble To Surface

The number of device recalls fell slightly in the final quarter of 2016. While troubles with software and mislabeling continue to be a thorn in industry's side, problems with sterility popped up as the third most common reason for a product recall.

Recalls Quality Control
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Policy

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Latest From Policy

Leap In US Sales Of IUDs Linked To Trump Election, ACA Repeal Efforts

Sales of contraceptive intrauterine devices rose in the 4th quarter of 2016 at some companies. The increase in interest in IUDs coincides with efforts to repeal Obamacare and eliminate contraceptive coverage guarantees, according to Planned Parenthood and AthenaHealth.

Gynecology & Urology Reimbursement

Brexit Podcast: Next Steps For The UK Medtech Industry

Ashley Yeo talks to Association of British Healthcare Industries' Nishan Sunthares and Richard Phillips about the subject that will dominate the thoughts, behavior and business of medical technology companies in the UK for many years to come.

Brexit United Kingdom

CMS Nominee Seema Verma Urges Caution On Competitive Bidding Program

Seema Verma, President Trump’s pick to run the US Medicare agency, told the Senate Finance Committee that rural areas should not have to comply with CMS’ medical supplies competitive-bidding program if it is not a good fit. Verma was also questioned on changes she might make to the Affordable Care Act and the Medicare program, but did not offer many specifics.

Policy Reimbursement

Device Week – Feb. 17, 2017

On this week's Medtech Insight podcast: US House Ways and Means Committee sets out plans for the next two years, including a review of all taxes and fees connected to the Affordable Care Act; Allergan and Hologic enter into separate big-money acquisitions in the aesthetics devices arena; a deep-dive look at the osteoporosis diagnostics market.

Regulation Policy

Unlocking Legalities: Gorsuch’s Impact May Be Felt On Free Speech, Preemption

Supreme Court Nominee Judge Neil Gorsuch has ruled favoring device companies on preemption, and in support of an inventor in a device patent case. But experts say the impact he would actually have on the court remains to be seen.

Unlocking Legalities Legal Issues

New Bill Aims To Bring Consistency, Transparency To US FDA Inspections

US Sens. Johnny Isakson, R-Ga., and Michael Bennet, D-Colo., introduced legislation that calls for adopting a uniform FDA inspection process to ensure parity between audits of foreign and domestic device firms, notifying manufacturers in advance of records that will be requested during an inspection, and specifying a window of time for investigators to conduct their onsite inspections, among other requirements.

Regulation Policy
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