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[FEATURED] MDR Or MDD: Which Route Should You Choose Now That The MDR Is Delayed?
With the recent EU decision to postpone the Medical Device Regulation by a year, what factors do medtech […]Read More[FEATURED] EU COVID-19 Response: Who Is Leading EU’s Decision-Making For Medtech?
The COVID-19 pandemic has meant seismic shifts in the way the EU has been operating to regulate and […]Read More[FEATURED] Drug/Device Combinations: New Position Paper Explains Notified Body Responsibilities
Medicinal products authorities will consider a medtech notified body opinion on the device element of a drug/device combination […]Read More[FEATURED] European Commission Recommends Regulatory Midway For COVID-19 Products
The EU is addressing the regulatory obstacles that threaten to reduce the speed at which vital products needed […]Read More[FEATURED] Commission Firm on MDR Deadline But Could COVID-19 Emergency Measures Alter Date?
As COVID-19 begins to hamper EU Medical Device Regulation preparations, questions are being asked about whether the regulation […]Read More[FEATURED] EU’s IVDR Could Spell Disaster In Halting Spread Of Next COVID-19-Type Virus
The spread of COVID-19 has been slowed in many places through widespread testing of infected patients’ contacts. But […]Read More[FEATURED] Premarket Innovators And SMEs (Part 2): Running Out Of Time In The EU MDR Race
In this second article of a two-part series, Eithne Lee of ISO Life Sciences global consultancy identifies some […]Read More[FEATURED] European Commission’s Missed Deadlines And Contingency Planning: Welcome To 2020!
2020 is not getting off to a good start for manufacturers needing to comply with the EU’s new […]Read More[FEATURED] CE Featured Article BSI’s Gary Slack Explains Why MDR Take-Up Is So Slow
There is not much demand currently for testing against the EU’s Medical Devices Regulation (MDR). But demand for […]Read More[FEATURED] It’s Raining Guidance Docs: FDA Expands Abbreviated 510(k) Program
In a new final guidance, the US agency has expanded its abbreviated 510(k) program for certain devices to […]Read More[FEATURED] 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 […]Read More[FEATURED] Regulators Urged To Avoid ‘Conflicting’ Clinical Requirements For Drug-Device Combinations In EU
EU regulators are being urged to get their skates on and publish guidance on new clinical requirements that […]Read More[FEATURED] It Is A Great Time to Move Within Regulatory – Especially If You Know What To Expect
The demand to fill EU regulatory roles is at its peak and is dictating the very nature of […]Read More[FEATURED] Global Call To Rethink MDR Timing Sees Commission Dig Heels In Further
The calls for a delay in the implementation of the new EU MDR are becoming increasingly loud on […]Read More[FEATURED] EU MDR: Handful Of Additional Notified Body Designations Await Go-Ahead
Recent indications from the European Commission led EU medtech stakeholders to believe that more notified bodies would have […]Read More[FEATURED] Commission’s Latest Stats Show How 10 MDR/IVDR Notified Bodies By Q3 2019 Is Now Possible
The European Commission’s latest figures indicate that at least 20 notified bodies will be designated by 26 May […]Read More[FEATURED] Two More Notified Bodies About To Be Designated And Surge In Publications Of New Documents
The European Commission came under a great deal of pressure in June to deliver the fundamental structures and […]Read More[FEATURED] Brexit Delay Gives EU27 Yet More Time To Grow Number Of EU-Compliant Devices
Has the European Commission done enough to allow UK-certified medical devices to continue on the EU27 market in […]Read More[FEATURED] No Need For UDI On Some Drug/Device Combinations In The EU
While UDI will be required on all products that come under the scope of the EU’s medical device […]Read More[FEATURED] Notified Body Q&A: 3 NBs Talk EU MDR Enforcement, The IVDR ‘Big Bomb,’ ‘Tough’ Regulators – And More Insights
MEDCERT’s Klaus-Dieter Ziel, TÜV SÜD Product Service’s Bassil Akra and Qserve Group’s Gert Bos answered questions about the EU’s […]Read More[FEATURED] EU Officially Designates Second Notified Body Under The MDR: TÜV SÜD Enters Center Stage
TÜV SÜD, headquartered in Germany, is the second notified body to be officially designated under the EU MDR. […]Read More[FEATURED] EU MDR Transparency Not Enough: Time For A Big Debate?
Increased transparency is often highlighted as one of the major steps forward in the new EU Medical Device […]Read More[FEATURED] The Cost And Complexity Of Implementing The EU Medical Device And IVD Regulations
Three experts talk about what it takes logistically for medtech businesses to prepare for timely compliance with the […]Read More[FEATRURED] One In Three Medtech Innovators Will Be ‘Driven Out Of Business’ By EU MDR, German Business Survey Finds
The EU Medical Device Regulation is 15 months away from being implemented in full, and a new German […]Read More[FEATURED] IVDR Notified Body Numbers – Has Enough Progress Been Made?
Will there be enough resources for IVD manufacturers to be audited in time against the EU’s IVD Regulation? […]Read More[FEATURED] Notified Bodies And EU Industry Voice Separate, But Aligned Frustrations Over Slow Progress In NB Designations
Notified body and medtech industry trade associations both issued formal statements pointing out that delays in designating notified […]Read More[FEATURED] 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 […]Read More[FEATURED] EU Regulatory Roundup, 2018: Year Of Dithering And Distractions Likely To Be Topped By Upcoming Year Of Turbulence And Stress
2018 needed to be medtech’s year to focus on the ongoing implementation of the EU MDR and the […]Read More[FEATURED] 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 […]Read More[FEATURED] Two EU Notified Body Frontrunners In Race For Designation Under New Regulations
The latest revelations in London and Brussels over the last week show concrete progress is being made toward […]Read More[FEATURED] When Will EU Commission, Member States React To Calls For Extending Regulation Deadlines?
The EU medtech sector, seeing itself heading for a crisis, is hoping the authorities will imminently extend deadlines for […]Read More[FEATURED] Q3 US Device Approvals Snapshot: Apps Up, Original PMAs Down
Mobile apps made major headway into the world of US FDA regulation in the third quarter, with de novo go-aheads […]Read More[FEATURED] FDA Guidance Looks At Benefit Vs. Risk In Certain 510(k)s
A newly finalized guidance document from US FDA explains how the agency will evaluate benefit and risk questions […]Read More[FEATURED] First EU Notified Body Designations Could Come Earlier Than Expected, But Caution Advised
There’s been progress toward designating notified bodies against the EU’s medtech regulations, but the developments need to be […]Read More[FEATURED] EU Post-Market Clinical Follow Up: What Manufacturers Need To Know
The EU’s new medtech regulations introduce much more comprehensive post-market clinical follow-up requirements for device and diagnostics companies. […]Read More[FEATURED] To What Extent Are Authorities Restricting Notified Body Activities?
How much do we know about what is happening in relation to unconfirmed reports that some European notified […]Read More[FEATURED] Medtech Tips: 7 Expert Pointers For A Successful Pre-Market Submission To US FDA
FDAer-turned-consultant Heather Rosecrans offers valuable tips for a successful submission, from avoiding sending a PMA or 510(k) to […]Read More[FEATURED] Commission’s Draft EU Standardization Request May Overwhelm Tech Committees At 11th Hour
A great many EU medtech standards may not be ready in time for manufacturers to demonstrate compliance with […]Read More[FEATURED] EU Regulatory Reads, June 2018: Experts Tell Industry To Get Moving Despite Shortfalls – Shift Later!
Pressure is building on companies to start compliance efforts to the EU Medical Device Regulation. But a good […]Read More[FEATURED] New Reasons Not To Use EU MDR’s Four-Year Extension, But Comply Earlier Or Retire Products Instead
The new EU Medical Device Regulation offers companies an option to market CE-marked devices for an extra four […]Read More[FEATURED] Substantial Drop In Certificates Withdrawn By EU Notified Bodies: Why Now?
Data from TEAM-NB, the EU notified body association, shows a big drop in withdrawn certificates from device firms. […]Read More[FEATURED] Does EU Regulation Of 3D-Printed Implants Expose Gap In MDR Regime?
“Given that 3D printing is used for making device implants, many would expect tight regulation. But the EU […]Read More[FEATURED] EU Regulatory Reads, 2017: Are We Heading Toward A 2018 Crisis?
“Since the EU’s new Medical Device and IVD Regulations took effect in May 2017, progress toward implementation has […]Read More2018 – Good For The Device Industry, Good For Patients, Good For FDA
Read through an interview with Maureen Mulvihill of Actuated Medical, Inc. as she shares her educated predictions on […]Read MoreEU MDR and Clinical Evidence: What You Need to Know
“One of the key objectives of the new EU MDR is to ensure a high level of health […]Read More[FEATURED] New 510(k) Modifications Guidance May Prompt New Submissions
US FDA has made at least nine changes releasing a final 510(k) modifications guidance on Oct. 24. This […]Read MoreNotified Bodies Disclose Re-Designation Intentions Ahead of EU MDR, IVDR Deadline
“European notified bodies are prepping for a 26 November deadline and announcing their intentions to apply for designation […]Read More[FEATURED] EU Regulatory Update: Where Do We Stand Now – On Shaky Ground?
“Most EU regulators are now back in the swing of work after their summer break and the conference […]Read MoreThe thinking process behind biopharma companies’ outsourcing management
Here are some top tips on managing smooth outsourcing relationships. Related posts 6 Project Management Secrets Used by […]Read MoreLearn From Past Mistakes: Preparing For MDSAP And International Commercialization
Learn about some of the most common European regulatory compliance mistakes and how to avoid them. Related […]Read More