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[FEATURED] Whole EU Medtech Industry Behind Latest Push To Have MDR Problems Tackled at Highest Levels
Warnings about lack of notified body capacity to certify products against the EU’s new medtech regulations have become […]Read More[FEATURED] EU Notified Body MDR/IVDR Certificates Data: A Slow-Motion Car Crash
Warnings about lack of notified body capacity to certify products against the EU’s new medtech regulations have become […]Read More[FEATURED] More Flexible Approach Proposed For EU Notified Body Technical Documentation Reviews
Shortfalls in manufacturer technical documentation submitted to notified bodies cause delays for manufacturers and notified bodies alike. A […]Read More[FEATURED] EU Proposal To Have Guidance Transition Periods “Does Not Make Sense”
A proposed position paper on time periods for notified bodies to roll out guidance documents aims to introduce […]Read More[FEATURED] FDA Publishes Final Guidance On Clinical Decision Support Software, Clarifies What Software Should Be Regulated As Medical Devices
In its final document, the US FDA outlines its interpretations of the four criteria for excluding clinical decision […]Read More[FEATURED] Calls For More Patient Input In Medical Device Development and Regulation
It is vital to involve patients in medical device development, regulatory assessments, and post-marketing activities. The European Patients’ […]Read More[FEATURED] EU MDR: Notified Body Clinical Evidence Expectations Could Spell Trouble for Manufacturers
Detailed guidance documents aim to provide clarity on what constitutes “sufficient” clinical evidence under the new EU Medical […]Read More[FEATURED] EU MDR Implementation Group Reinforces Historic Clinical Evidence Guidance Document Value
Determining how to provide adequate clinical evidence for CE marking under the EU’s Medical Device Regulation can be […]Read More[FEATURED] Much More Is Needed, Industry Says To EU’s 19-Point Regulatory Action Plan
The new EU Medical Device and IVD Regulations are reaching a critical tipping point. The 19-point plan just […]Read More[FEATURED] Why EU Regulations Are Changing The Face Of Innovation And May Be Unsustainable
The EU must keep its medtech regulation under review as rapidly changing technology and external market factors may […]Read More[FEATURED] No Quick Fix When It Comes To EU MedTech Notified Body Designations
Latest information from the European Commission suggest that future notified bodies designated under the MDR, and even the […]Read More[FEATURED] European Commission Publishes Draft Rules In Bid To Reclassify Non-Medical Active Products Latest Italian Designation Means Germany
The European Commission has launched an initiative to ensure products without a medical purpose that fall under the […]Read More[FEATURED] Latest Italian Designation Means Germany and Italy Are Home to Half EU’s MDR Notified Bodies
While each new designation of a notified bodies in the medtech space is good news, many more organizations […]Read More[FEATURED] European Regulatory Roundup, July 2022: Threat of Ongoing Hurdles Masks Progress
The first seven months of 2022 have seen significant progress on documents, tools and new structures needed for […]Read More[FEATURED] Multiplex IVDs Position Paper Could Help Relieve Pressure On Notified Bodies
With notified bodies under increasing IVDR workload pressure, their representative associations have come up with one solution that […]Read More[FEATURED] European Commission Expects Eudamed To Be Fully Ready By Q2 2024
The European Commission has published an updated timeline for delivering the EU medical device database. Regarded as the […]Read More[FEATURED] Here At Last: EU’s Implementing Regulation On Common Specifications For Class D IVDs
The EU has published a total of 61 pages of technical specifications for the higher risk, Class D […]Read More[FEATURED] European Regulatory Roundup, June 2022: Solutions Needed As MDR/IVDR Frustrations Grow
June was characterized by an intense debate focused on shortfalls in the implementation of the EU MDR and […]Read More[FEATURED] Commission Offers Glimpse Of Actions To Speed Up MDR Compliance
With a sense of desperation building among stakeholders over the challenges in ensuring all products are compliant with […]Read More[FEATURED] Pew Responds To Draft Legislation Creating Regulatory Oversight Of Lab Developed Diagnostics
The time to create a flexible, risk-based regulatory system for all in vitro diagnostics is now, Pew tells US lawmakers, […]Read More[FEATURED] EU MedTech Forum 2022: Regulatory Unpredictability Spurs Renewed Calls For Devices Agency
In the EU, lack of regulatory predictability is creating frustration, sending innovators across the Atlantic, and has been […]Read More[FEATURED] Risk Management Update Published Within Days for EU MDR Use
Medtech companies will soon be able to reference an updated European version of the international risk management standard […]Read More[FEATURED] Device/Drug Borderline: Gray Areas Remain Despite New EU Guidance
New EU guidance aims to provide clarification, but some difficult and nuanced decision-making is still left to the […]Read More[FEATURED] EU’s Risk Management Standard Officially Recognized In Context of the IVDRU
Only one new standard has been added to the official list of standards recognized in the context of […]Read More[FEATURED] EU IVD Regulation: Guidance on Significant Changes Now Available
With just a few weeks to go until the IVD Regulation fully applies, much-needed guidance has been published […]Read More[FEATURED] Against The Odds: Notified Bodies Pinpoint The Real Obstacles And Ways To Move Past Them
With demand for EU notified body medtech services fast outstripping capacity, three well-known notified body experts explain how […]Read More[FEATURED] Updated: New MDR Notified Body Designations Pending, But Only One Under IVDR Until Late 2022
Latest figures published by the European Commission show some progress can be expected soon when it comes to […]Read More[FEATURED] European Commission Adds To Advice On High Risk Device Safety And Performance Requirements
The European Commission’s MDCG has issued revised guidance and advice on safety and clinical performance data required for […]Read More[FEATURED] European Regulatory Roundup, March 2022: Unprecedented Hiatus In Implementation Announcements
Unprecedented silence from the EU when it comes to news relating to the implementation of the Medical Device […]Read More[FEATURED] EU Post-Market Surveillance: How Doing More Than Minimum Will Benefit Medtech Manufacturers
Post-market surveillance requirements apply to all products under the EU’s Medical Device Regulation. Companies would do well to […]Read More[FEATURED] Some 20 Key EU Guidance Documents Still Needed For MDR And IVDR Implementation
On 26 May this year, the EU’s Medical Device Regulation will have been in effect for a year, […]Read More[FEATURED] Guidance Sets Out How Notified Bodies Must Assess Highest Risk IVDs Under New Regulation
The highest risk IVDs, which fall into class D, are subject to additional testing criteria. New guidance explains […]Read More[FEATURED] European Commission’s 2022 Schedule: Major Focus On Eudamed Database
The European Commission has published the schedule of meetings of its Medical Device Coordination Group for 2022. Launching […]Read More[FEATURED] Pharma, Device Groups Oppose FDA’s Planned Drug to Device Transition
Pharmaceutical industry trade groups and medical device groups objected to the US Food and Drug Administration’s (FDA) plans […]Read More[FEATURED] Notified Body Shortage Remains Pressing as Industry Prepares for Staggered IVDR Rollout
Three months have passed since the European Commission warned about a “grave shortage of notified body capacity,” but […]Read More[FEATURED] Commission Publishes Draft Implementing Regulation For Insufficiently Regulated Products
The European Commission has published the schedule of meetings of its Medical Device Coordination Group for 2022. Launching […]Read More[FEATURED] Commission Publishes Draft Implementing Regulation For Insufficiently Regulated Products
At last, common specifications for different groups of products that do not have an intended medical purpose but […]Read More[FEATURED] Updated Version Of EN ISO 13485 Now Officially Harmonized Under MDR Along With Other Standards
The New Year has seen the official publication of a series of long-awaited new medtech standards, including some […]Read More[FEATURED] Industry Points To Key Outstanding IVDR Issues As EU Council Greenlights Deadline Extensions
The Council of the EU has followed the European Parliament in rubberstamping the European Commission’s proposal for selected […]Read More[FEATURED] EU Notified Bodies Warn Of Major Obstacles To MDR/IVDR Implementation
TEAM-NB, the EU notified body association, warns of disruption in device supply if critical action is not taken […]Read More[FEATURED] Where And How eIFU Rules Will Apply Under The EU’s Medical Device Regulation
Provision of electronic instructions for use for devices is now a well-established practice. But there are conditions. A […]Read More[FEATURED] Find Resources To Designate IVDR Notified Bodies, Commission Tells Member States
There is growing impetus at the highest EU levels towards ensuring the IVD Regulation is implemented as quickly […]Read More[FEATURED] EU’s First IVDR Expert Panel View Published
The very first expert panel opinion under the Medical Device Regulation was published this summer, but quickly withdrawn. […]Read More[FEATURED] Timelines And Deadlines For Stakeholders To Submit Information To EU’s Eudamed Database
IT system deadlines are renowned for being delayed. With speculation that the full implementation of the Eudamed medical […]Read More[FEATURED] Are Latest Challenges Threatening To Push Eudamed Launch Date Into 2023?
While nothing is official yet, it seems that the EU is likely to struggle to have two of […]Read More[FEATURED] FDA-Backed Tumor Mutation Database Gives Diagnostics Developers Another Premarket Submission Tool
The US FDA on 7 October recognized a portion of the Oncology Knowledge Base, or OncoKB, which test […]Read More[FEATURED] MRA Or Not, Swiss Medtech Industry Urges Maximum Convergence With EU MDR
Swiss domestic medtech manufacturers reluctantly accept Switzerland’s new status as a third country to the EU, but the […]Read More[FEATURED] Latest European Commission Figures Suggest One More IVDR Notified Body In Pipeline And Then A Gap
The European Commission has updated its figures on the status of readiness of notified bodies under the Medical […]Read More[FEATURED] EN ISO 13485 and EN ISO 14971: Next Wave Of EU Standards Now Due ‘By December’
The EU Medical Device Regulation applied in May, but the 200 or so associated standards that support it […]Read More[FEATURED] EU Is Heading For Partial IVD Market Collapse, Recent Analysis And Figures Suggest
With just six notified bodies designated under the IVD Regulation, and amidst repeated warnings of insufficient auditing capacity, […]Read More[FEATURED] European Commission Gives In On IVDR Delays: Proposal For New Transition Periods
The pressing circumstances created by the ongoing COVID-19 pandemic has resulted in the commission not only accepting compliance […]Read More[FEATURED] How The MDR Is Making The EU Competitively Backward
Pedantic versus pragmatic implementation of the EU MDR and its guidances, as well as notified bodies struggling with […]Read More[FEATURED] EN ISO 13485 Linked To MDR and IVDR At Last
Nearly four months after the full application date of the EU’s Medical Device Regulation, the EU standards bodies […]Read More[FEATURED] GMed Designated Under EU IVD Regulation
In the EU, there are now six EU notified bodies designated under the IVD Regulation. French notified body, […]Read More[FEATURED] QSR Q&A: 5 Top Medtech Experts Answer 6 Burning Questions About FDA’s Coming Quality Reg Redo
For this “man on the street” feature, Medtech Insight rounded up industry experts Kim Trautman, Vincent Cafiso, Steve Niedelman, Kwame […]Read More[FEATURED] Notified Bodies Assessing High-Risk IVDs May Sometimes Need To Pause Product Reviews
New EU guidance tells notified bodies they must wait to issue a certificate for a high-risk IVD in […]Read More[FEATURED] EU Prioritizes Risk Management And Quality System Standards Now Legal Basis In Place
Ensuring key standards for MDR and IVDR compliance are available for manufacturers is one of the top priorities […]Read More[FEATURED] How To Comply With New Requirements For Companion Diagnostics Under IVDR
The regulation and requirements for companion diagnostics will be far stricter under the IVDR than the current IVD […]Read More[FEATURED] How Notified Bodies Must Ensure Appropriately Qualified Staff Assess Each IVD
Notified bodies must have a system in place to ensure that IVD devices are assessed by individual staff […]Read More[FEATURED] MDR Practicalities: Companies Explain Impact Of Notified Body Timings And Questions Process
Manufacturers initiate an intense communication process when they apply for notified body conformity assessment of their product or […]Read More[FEATURED] EU Coordinates Market Surveillance For The First Time: Pilot Being Launched
‘JAMS’ has been strengthening the European market surveillance network and helping lower-resourced member states develop skills and capacity. […]Read More[FEATURED] EU Drug And Device Authorities Take Steps Toward More Collaborative Working
The EU’s Competent Authorities for Medical Devices group has been meeting with the Heads of Medicines Agencies to […]Read More[FEATURED] Commission’s eIFU Draft Unleashes Diametrically Opposed Views Among Device Users
Industry wants to see the number of products for which electronic IFU are permitted to be expanded. But […]Read More[FEATURED] Commission Calls For Notified Body Applicants As It Recognizes EU IVD Industry In Some Trouble
The European Commission is publicly recognizing the huge hurdles ahead for the IVD industry in complying with the […]Read More[FEATURED] How To Navigate MDR, Brexit And COVID-19 Candidate-Driven Medtech Recruitment Market
COVID-19 layered on top of Brexit has created unique challenges and opportunities in the EU and UK medtech […]Read More[FEATURED] Sprinting To Approval: Insider Tips On FDA’s Breakthrough Devices Program
There are some golden career opportunities for medtech regulatory candidates right now. In this preview article to a […]Read More[FEATURED] Sprinting To Approval: Insider Tips On FDA’s Breakthrough Devices Program
Manufacturers applying to the program should be ready for questions from the US agency, an FDA official says. […]Read More[FEATURED] Communication, Cooperation, Harmonization: Experts Generate New EU Regulatory Momentum
There was a refreshingly different debate on the future of EU medtech regulations at the start of the […]Read More[FEATURED] Commission Calls For Notified Body Applicants As It Recognizes EU IVD Industry In Some Trouble
The European Commission is publicly recognizing the huge hurdles ahead for the IVD industry in complying with the […]Read More[FEATURED] Open The Champagne! EU Go Ahead For Standards Needed For New Medtech Regulations
The EU has the green light to adopt and list standards that will be recognized under the MDR […]Read More[FEATURED] EU MDR Guidances: Can Stakeholders Be Punished For Not Applying Them?
Over 70 guidance documents have been drafted to support MDR implementation. But there is confusion over whether guidance […]Read More[FEATURED] Commission Optimistic Over EU MDR Readiness While Others See A Flawed System
The European Commission is satisfied with the state of readiness of the EU MDR, but for TÜV-SÜD’s Sabina […]Read More[FEATURED] TEAM-NB Highlights Survey Figures Suggesting Massive 2024 Bulge In MDR Applications
Growing evidence demonstrates the one-year delay to the Medical Device Regulation, plus the expansion of the scope of […]Read More[FEATURED] High-Risk Class D IVDs: Some Good News, Some Bad News About IVDR Implementation
The European Commission’s just updated Rolling Implementation Plan for the MDR and IVDR shows delays in key structures […]Read More[FEATURED] Medtech Standards Request Advances – But Too Late For MDR/IVDR First Wave
The medtech sector may, at last, be one step closer to ensuring standards are drafted or revised under […]Read More[FEATURED] EU Regulations At A Click: Top 10 Most Useful MDR/IVDR Webpages
The EU Medical Device Regulation will have impacts in countries beyond the EU27, a fact that is keeping […]Read More[FEATURED] Device Firms In Non-EU Markets Using The CE Mark Should Expect Some MDR Disruption After May
Health care is about to suffer a major setback and some devices and IVDs are going to have […]Read More[FEATURED] Why The Humble Swab Could Be A Seriously Disruptive Element In The MDR And IVDR
Health care is about to suffer a major setback and some devices and IVDs are going to have […]Read More[FEATURED] EU MDR Notified Body Designations Could Soar By A Third By End Of 2021
Without the MRA that allows unimpeded bilateral device trade between the EU and Switzerland, Swiss industry is having […]Read More[FEATURED] Signs Of Hope But Obstacles Remain For Swiss Device MRA With EU
Without the MRA that allows unimpeded bilateral device trade between the EU and Switzerland, Swiss industry is having […]Read More[FEATURED] EU Must Up Pressure To Secure Swiss Device MRA Or Transitional Arrangements
Patient care and device trade will suffer without urgent attention to the signing of the EU-Switzerland medtech mutual […]Read More[FEATURED] Commission Issues New Guidance On Registering And Identifying Legacy Devices In Eudamed
The process for registering legacy devices is like that for registering devices in conformity with the MDR. But […]Read More[FEATURED] EU Notified Bodies Advise Manufacturers To Think Hard About Regulatory Strategy Timings
Industry holding out for IVDR delay but fears resurface over MDR bottlenecks in 2023-24 Waiting until the grace […]Read More[FEATURED] EU Notified Body Association Takes Steps To Allay EC’s Virtual Audit Fears
The European Commission has reluctantly allowed virtual audits in the context of new MDR and IVDR. The EU […]Read More[FEATURED] Common Regulatory Starting Point Means EU-UK Are On Track For Medtech MRA, Say German Firms
With Brexit less than a month old, Germany’s medtech industry has renewed its push for an MRA between […]Read More[FEATURED] Lobbying For A One-Year Delay To The EU IVDR: Solution Or Forlorn Hope?
The IVD Regulation is due to fully apply in May 2022. The necessary infrastructure looks unlikely to be […]Read More[FEATURED] First MDR Notified Body Designated In Finland As Nordic Numbers Nudge Up
The latest update in the Medical Device Regulation page of the European Commission’s Nando database represents the 18th listing […]Read More[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
