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Policy & Regulation

Set Alert for Policy & Regulation

Q3 Recalls Snapshot: Recalled Devices Slide In Third Quarter; Software A Nagging Issue

Good news for the medical device industry: After two record-setting quarters, the number of recalled products and device units fell in the third quarter of 2018. Yet device-makers are still having problems with software, which was the leading cause of recalls in Q3. Check out our Q3 recalls infographic.

Recalls Safety Quality Control

Canada Consults On Licensing Of 3D-Printed Device Implants

A new draft guideline issued by Health Canada represents the first phase of a 3D-printing policy in Canada.

Canada Policy & Regulation Medical Device
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Regulation

Set Alert for Regulation

How Belgium's New Local Distribution Rules Will Impact Companies Doing Business There

With new legislation imminent in Belgium on distribution rules for medical devices, how much more open is the market going to become, and what must companies be aware of? Two experts discuss.

Belgium Medical Device Europe

Latest From Regulation

QUOTED. Nov. 19, 2018. Erik Hansson.

The number of countries to which the EU's MDR and IVDR will apply totals 33. But the regulations will impact many more markets than that, according to Erik Hansson, deputy head of the European Commission unit that oversees medical devices. See what he said here.

Quoted Regulation

FDA Wrestles With Social Media At Patient Engagement Meeting

US FDA device center's new Patient Engagement Advisory Committee held its second meeting on Nov. 15, focusing on the potential for social media and other patient-generated information to be a source of post-market medical device data.

Post Market Regulation & Studies Medical Device

QUOTED. Nov. 16, 2018. Scott Gottlieb.

US FDA is proposing to amend its regulations to allow an institutional review board to waive or alter informed consent when a clinical investigation "poses no more than minimal risk" to human subjects and includes safeguards to protect their rights and safety. See what agency head Scott Gottlieb said about it here.

Quoted Clinical Trials

33-Country Single Market For MDR And IVDR, And Bigger Reach Beyond

More often than not, the new EU Medical Device and IVD Regulations are talked about in the context of the 28 countries of the European Union (including the UK, for now). In reality, the regulations will have a much wider reach and influence, with Australia making particular efforts to align with the EU.

International Europe

QUOTED. Nov. 15, 2018. Beth Weinman.

Beth Weinman, a former enforcement lawyer in US FDA’s Office of Chief Counsel, says "a big payout" is a strong carrot for someone to file a whistleblower complaint against a device-maker. Check out what Weinman says is another top motivator here.

Compliance Enforcement

US FDA Warns Against Using Unapproved Drugs In Implantable Pumps

Regulators say they have found a correlation between patients given pain medication not approved for their specific implantable drug pumps and a higher number of adverse events.

Safety Drug Delivery
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Quality Control & Compliance

Set Alert for Quality Control

'An Unnecessary Editorial Revision': In Letter, MDSAP Council Rails Against ISO's Push To Change 13485 Quality Standard

The chair of the Medical Device Single Audit Program (MDSAP) Regulatory Authority Council is warning of "instability" in industry if the International Organization for Standardization (ISO) Technical Management Board has its way and makes changes now to international quality systems standard ISO 13485.

International Standards Quality

Latest From Quality Control

Fresh From US FDA's Chief Counsel Office, Beth Weinman Talks Qui Tam And Compliance

Beth Weinman, a former enforcement lawyer in US FDA’s Office of Chief Counsel, recently joined the life sciences and FDA regulatory practice at Ropes & Gray. She spoke with Medtech Insight about whistleblower suits and FDA enforcement priorities.

Compliance Enforcement

US FDA Tweaks Direct Marking Rules In UDI Enforcement Delay

FDA’s latest update to Unique Device Identification compliance deadlines says the agency won’t enforce direct marking UDI rules for some existing devices if the UDI can be determined in other ways.

Enforcement Compliance

ISO Wants To Tinker With Quality Systems Standard 13485:2016. Let ISO Know What You Think By Nov. 9

Device firms don't have to conform to the latest version of ISO 13485 until March 2019, yet the International Organization for Standardization (ISO) Technical Management Board is champing at the bit to open up the quality systems standard for a rewrite. In response, ISO Technical Committee 210 has developed a survey to determine how changing the standard will affect device-makers and other stakeholders. TC210 wants to "gather opinions from the users [of ISO 13485] to justify why no immediate revision is desired, especially in light of all the regulatory changes that are coming," TC210 delegate Kim Trautman says. The survey closes Nov. 9.

International Standards

Compliance Corner: 8 Handy Tips From An MDSAP Auditor To Help You Ace Your Next Audit

NSF International's Brian Ludovico offers up advice for device-makers facing an audit under the Medical Device Single Audit Program.

Compliance Corner International

Investigator Horror Stories 3: Boozing On The Job? Yup, That Happened – As Have These Other Shocking Tales Of Irregular FDA Inspections

In the final chapter of our Investigator Horror Stories trilogy, former US FDA investigations branch director Ricki Chase tells how one agency investigator blatantly drank alcohol and asked for bathing suit suggestions during an audit in Greece, and longtime industry insiders Steve Niedelman and David Chesney offer up three bone-chilling stories of investigators who stepped over the line. Check out how they handled the outlandish inspections in this Compliance Corner threequel.

Compliance Corner FDA

FDA Hasn't Publicly Released A Device-Related Close-Out Letter For 5 Months, Defeating Purpose Of Program

Medical device manufacturers under the dark cloud of a US FDA warning letter work hard to close them out, and, importantly, receive a close-out letter from the agency that is posted online for everyone to see. Yet FDA hasn't publicly released such a missive to device companies since May – the longest gap since the close-out program began in 2010. FDA says it's aware of the problem.

FDA Compliance
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Policy

Set Alert for Policy

Latest From Policy

QUOTED. Nov. 19, 2018. Erik Hansson.

The number of countries to which the EU's MDR and IVDR will apply totals 33. But the regulations will impact many more markets than that, according to Erik Hansson, deputy head of the European Commission unit that oversees medical devices. See what he said here.

Quoted Regulation

33-Country Single Market For MDR And IVDR, And Bigger Reach Beyond

More often than not, the new EU Medical Device and IVD Regulations are talked about in the context of the 28 countries of the European Union (including the UK, for now). In reality, the regulations will have a much wider reach and influence, with Australia making particular efforts to align with the EU.

International Europe

UK MHRA Response To Brexit Questions Still Leaves Gaps And Uncertainty For Medtech

As UK Prime Minister Theresa May tries to get her cabinet to accept the draft Brexit agreement between the UK and EU, Medtech Insight looks at the potential confusion for medtech should she fail.

Brexit United Kingdom

BSI Is Designated In Netherlands, Giving Clients Go-Ahead To Start Transfer Of Certificates

With a high level of uncertainty still surrounding Brexit negotiations,  UK-based notified body BSI can now offer its clients a more certain future by migrating their certificates to BSI Netherlands if they wish.

Medical Device Brexit

Complying On Time With MDR/IVDR: What Options Are Open To Those In Trouble?

Manufacturers who have not managed to transfer their certificates from a UK notified body prior to Brexit, or who have not obtained certificates under the EU Medical Device or IVD Regulations in time, can not expect to receive a sympathetic hearing from the EU Commission. In an interview with Medtech Insight, Lawyer Alison Dennis examines options for medtech firms.

Europe Medical Device

AdvaMed Making Push For Device Tax Repeal In Lame Duck Session

The "lame duck" session of Congress before newly elected members take their seats in January may be the best shot available for the device industry to win permanent device tax repeal, lobby group AdvaMed says. The group is making a major effort to repeal the tax before the new Congress takes over.

Legislation Policy
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