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[FEATURED] Eudamed: Industry Warned That Additional National Actor Registration Requirements Possible While Database Is Voluntary
As manufacturers and other economic operators gets to grips with voluntary registration in the Eudamed database, they need […]Read More[FEATURED] COVID-19 And FDA: Official Tells How Pandemic Has Affected Agency’s Regulatory Work
US FDA device center associate director Erin Keith explained how the agency adapted – and continues to adapt […]Read More[FEATURED] EU Industry Is Largely Ready For Brexit: This Is Why
Brexit will be painful economically for medtech and create more work for companies in the remaining 27 EU […]Read More[FEATURED] Fivefold Increase In MDR Notified Body Demand Could Lead EU Into Chaos
Latest EU survey predicts unprecedented hike in demand for notified body assessments between 2021 and 2024 and insufficient […]Read More[FEATURED] EU Notified Bodies Demand IVDR System Readiness Or Deadline Review By Year End
If the tools are not in place by the end of 2020 to allow diagnostics companies to comply […]Read More[FEATURED] Notified Body Pain Points: The Challenges And Obstacles Industry Needs To Avoid
Where are the biggest challenges for notified bodies and manufacturers now there is some experience with the MDR, […]Read More[FEATURED] Making The Leap From EU MDD To MDR Clinical Evidence (Part 1): Practical Advice
Clinical evidence requirements are among the biggest challenges for manufacturers meeting the requirements of the EU’s new Medical […]Read More[FEATURED] Deadlines Needed For Urgent EU MDR Vigilance And Postmarket Surveillance Guidance Documents
Some 46 guidance documents still need to be drafted by the European Commission’s Medical Device Coordination Group before […]Read More[FEATURED] IVDR Implementation Not Yet On Track: What The Diagnostics Sector Needs To Do
The start date for voluntary registration in the Eudamed 3 database is fast approaching. It is open to […]Read More[FEATURED] How To Register In Eudamed By The December Start Date Commission Explains
The start date for voluntary registration in the Eudamed 3 database is fast approaching. It is open to […]Read More[FEATURED] EU Faces MDR Failure Unless It Adjusts To COVID-19 Crisis And Grows Notified Bodies
Is the current pandemic too big a hurdle for the EU’s medtech regulators and industry alike? What else […]Read More[FEATURED] Why Many MDD Certificates Will Be Invalid Before Their MDR Replacements Can Be Issued
The initial virtual audit ban is just one obstacle to timely EU MDR compliance. Another is that many […]Read More[FEATURED] Firms With Rocky MDR Compliance Histories Shut Out Of FDA Adverse Event Program
The US agency has updated its Medical Device Reporting website with information on which products qualify for its […]Read More[FEATURED] Requests For Additional Information During EU Audits – What To Expect And How To Avoid Them
A trend toward additional information demands from EU notified bodies risks delays and additional costs. One regulatory expert […]Read More[FEATURED] Industry Awaits Commission Ruling On Virtual Audits Under MDR
Many medtech companies are ready to demonstrate compliance with the EU MDR, but COVID-19 notified body auditing restrictions […]Read More[FEATURED] EU IVDR: Risk Of Noncompliance Is A Real Threat Under Current Deadline Pressures
Cries for the EU to pay more attention to IVDs are growing louder by the day. It is […]Read More[FEATURED] FDA Updated Its eMDR System. Here’s What You Need To Know When Submitting Adverse Events
Executive Summary The US agency has completed planned modifications to its electronic Medical Device Reporting system – and […]Read More[FEATURED] EU MDR Compliance Will Cost More Than 5% Of Revenues For Half Of Medtechs, Survey Says
Almost half of companies polled on extra resources needed to comply with the EU Medical Device Regulation are […]Read More[FEATURED] EU UDI: Commission Explains Basics And Addresses Uncertainties In Q&A Document
Unique Device Identification (UDI) is key to better transparency and traceability in the EU. But this UDI is […]Read More[FEATURED] Unprecedented Number Of EU Medtech Guidance Documents Now Available On New Commission Website
The European Commission’s output of guidance documents over the last few months has been extraordinary, and unprecedented. A […]Read More[FEATURED] European Commission Unlikely To Allow Virtual Audits Under MDR/IVDR In The Short Term
The COVID-19 pandemic has made physical audits of manufacturers unsafe, and demand for auditing is set to reach […]Read More[FEATURED] Competent Authorities Warn EU Industry Not To Expect All MDR Implementation Tools In Time
Preparing all items needed to support the implementation of the EU’s Medical Device and IVD Regulations in time […]Read More[FEATURED] What Next For Standards As CEN/CENELEC Reject MDR/IVDR Commission Request?
The timetable for developing harmonized standards under the EU’s Medical Device Regulation was already tight, even with new […]Read More[FEATURED] FDA To Makers Of EUA Devices: Don’t Forget To Report Adverse Events
Manufacturers of devices granted emergency use authorization (EUA) status during the COVID-19 crisis are fully responsible for filing […]Read More[FEATURED] Devices Containing Ancillary Medicines Likely To Need ‘Near Full Review’ Under MDR
Latest EU guidance highlights the challenges ahead for class III, high-risk, device/drug combinations when preparing for compliance under […]Read More[FEATURED] New EU Association Supports EU Regulatory Compliance Role As Responsibilities Take Shape
Those appointed in the new role of Person Responsible For Regulatory Compliance (PRRC) under the EU MDR are […]Read More[FEATURED] Why The EU Urgently Needs A One-Year Delay For The IVDR And EU-Wide Exceptions For IVDs
The medtech industry’s call for a one-year delay to the Medical Device Regulation and for EU-wide exceptions from […]Read More[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