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Policy & Regulation

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EU To Join Countries Covered By India’s Clinical Investigation Waiver Rule

Indian regulators intend to waive their clinical investigation requirements for certain medical devices that are already approved in the EU.

Clinical Trials India Europe

Hong Kong Poised To Speed Up Device Approvals

The Medical Device Control Office is to launch a trial program for expediting the approval of certain classes of medical devices.

Approvals Regulation Hong Kong
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Regulation

Set Alert for Regulation

MTI Profile: US FDA's Second-In-Command Has Her Eye On A Tech-Forward Future

As principal deputy commissioner of the FDA, Amy Abernethy is focused on developing overarching policies that affect all its product centers. But perhaps what will stand as her legacy is her work to develop a data-centered strategy to improve how the agency reviews products and ensures their long-term safety and efficacy.

Leadership FDA Regulation

Latest From Regulation

German Industry Says MDR Implementation 'Too Slow' But Negative Economic Effects Still Largely Unreported

The European Commission needs to be faster and more efficient in its implementation of the new EU Medical Device Regulation (MDR), say German manufacturers, watching the remaining months of transition time slip into single figures. A few economic operators have come clean about the pressure the MDR has brought to bear, but the suspicion is that many are choosing to keep quiet.   

EU Germany

Class I Recall On Edwards Sapien 3 Ultra Valve System

An ongoing recall of Edwards Lifesciences’ Sapien 3 Ultra transcatheter heart valve system has been elevated to Class I, indicating the US FDA’s highest risk level.

Recalls Cardiology

Dynamic China Moves Into The Fast Lane Of Medtech Regulatory Improvements

The Chinese medtech regulatory system was a key theme at the MedTech Summit in June, where regional specialists gave updates on registration timelines and electronic submissions, and signaled how the world’s biggest market-in-waiting is speeding up its regulatory improvements in a bid to become more open and less forbidding for overseas entrants.

China Regulation

Cost Of Certification Under IVDR Is Going To Be Huge As Manufacturers Battle Hurdles

There has been no recent impact assessment as to how business will be affected by the text of the IVD Regulation that was finally adopted. Consultant Robyn Meurant explains how industry will be paying a high price, and why many IVD companies could go under.

United Kingdom Australia

Raine To Lead UK MHRA Ahead Of Permanent Head Announcement

June Raine has agreed to lead the Medicines and Healthcare products Regulatory Agency temporarily after the agency’s incumbent chief executive steps down in September.

Regulation United Kingdom

IMQ Appointment As Fourth Notified Body Under MDR: Good News But Big Questions

There are now four notified bodies designated under the new EU Medical Device Regulation. But that is not enough, and new designations do not mean immediate testing either.

Medical Device Europe
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Quality Control & Compliance

Set Alert for Quality Control

Warning Letter Roundup & Recap – 21 August 2019

A maker of in vitro diagnostics was dinged for premarket, quality systems, Medical Device Reporting and corrections & removals violations. It's just one of two device-related warning letters released by the US FDA this week.

Device Warning Letters FDA Enforcement

Latest From Quality Control

Compliance Corner: 2 FDA Compliance Branch Heads Talk Regulatory Meetings – And What You Can Expect

US FDA Compliance Branch directors Gina Brackett and Melissa Michurski shed light on the agency's use of regulatory meetings. The FDA has been pulling enforcement punches in recent years, relying more on holding the face-to-face meetings than sending warning letters.

Compliance Corner FDA

Warning Letter Roundup & Recap – 13 August 2019

A maker of medical equipment, health-care supplies, and radiation products used for general and plastic surgery was cited for quality systems violations in the only device-related warning letter released by the US FDA this week.

Device Warning Letters FDA

EU And US Could Do More Together In Areas Of Medtech Approvals And Inspections

Will medical devices be among the next sectors to feature in the EU/US MRA? The EU has put forward suggestions on how to do device trade with the US through building regulatory co-operation.

Medical Device Europe

Compliance Corner: FDA Investigator Sees These 4 Common Sterilization Problems When Inspecting Facilities

Phil Pontikos, who is also the US agency's national device expert, explains how device-makers can avoid running afoul of the FDA's rules and expectations for sterilization activities.

Compliance Corner FDA

New Heartache For Abbott Implantable Cardiac Devices After Manufacturing Flaw Discovered

US regulators have notified the public about a recall of certain Abbott Ellipse implantable cardioverter defibrillators that are prone to electrical shorting due a manufacturing flaw. While the number of devices so far in the US is very small, the recall highlights continued issues with the ICDs since Abbott acquired them from St. Jude almost three years ago.

Regulation Safety

Warning Letter Close-Outs – July 2019

The US FDA released three device-related close-out letters in July.

Device Warning Letters FDA
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Policy

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Latest From Policy

Sir Andrew Dillon Standing Down As Head Of England’s NICE After 20 Years

Sir Andrew Dillon is stepping down from what has been described as one of the most challenging and potentially controversial roles in British public life.

Health Technology Assessment United Kingdom

Cost Of Certification Under IVDR Is Going To Be Huge As Manufacturers Battle Hurdles

There has been no recent impact assessment as to how business will be affected by the text of the IVD Regulation that was finally adopted. Consultant Robyn Meurant explains how industry will be paying a high price, and why many IVD companies could go under.

United Kingdom Australia

Recruitment Focus Part 3: What Is Really Driving EU Medtech Regulatory Recruitment?

Ten key take-home messages from recent interviews with recruitment expert Elena Kyria on the impact of the new medical device regulations on recruitment in the EU. This is the third and final installment of the first part of an ongoing series of articles on this topic. The second series will begin in September. 

Medical Device Europe

Ambu Settles US Defense Department False-Claims Allegations

Danish device-maker Ambu has agreed to pay $3.3m to resolve allegations of False Claims Act violations. The company is said to have made medical product in Malaysia and China for sale to the Departments of Defense and Veterans Affairs, which is forbidden under the Trade Agreements Act.

Enforcement Policy

DEKRA Soon To Start Transfer Of Clients To MDR And Has Priority Products

The official designation of a notified body in the European Commission’s Nando database is the trigger for that notified body to begin testing. But can manufacturers expect immediate service from DEKRA?

Medical Device Europe

Updates On The European Commission’s Medtech Agenda And Deadlines For The Rest Of 2019

The European Commission updates its rolling plan on progress with key document and structures toward implementation of the new medtech regulations every few months. What is new and what is still to come this year?

Europe Medical Device
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