#mdr transition extension

[izielhealthcare]

MDD to MDR Transition for Medical Devices

The transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) marks a significant change in the regulatory framework for medical devices in the European Union (EU). The MDR came into full effect on May 26, 2021, replacing the MDD and introducing more stringent requirements for the marketing and oversight of medical devices.

Here are some key points to consider regarding the transition from MDD to MDR for medical devices:

1. Scope and Classification: The MDR has a broader scope and includes a wider range of medical devices than the MDD. It introduces new classification rules, which might result in the reclassification of some devices.

2. Conformity Assessment: The MDR emphasizes a risk-based approach to conformity assessment. It introduces stricter requirements for clinical evidence and post-market surveillance. Manufacturers need to provide more comprehensive data on safety, performance, and clinical benefit.

3. Unique Device Identification (UDI): The MDR mandates the use of Unique Device Identifiers (UDIs) for better traceability of devices throughout their lifecycle. UDIs provide information about the device's identity, origin, and production history.

4. Post-Market Surveillance: The MDR places greater emphasis on post-market surveillance and vigilance. Manufacturers are required to actively monitor the performance of their devices on the market and report any incidents or safety concerns.

5. Economic Operators: The MDR introduces new roles for economic operators in the supply chain, including importers and distributors. These entities have specific responsibilities related to device oversight and reporting.

6. Clinical Data Requirements: The MDR sets higher standards for clinical data and requires more extensive clinical evaluation for devices, especially for high-risk devices. Clinical data must support the device's safety and performance claims.

7. Notified Bodies: Notified Bodies play a crucial role in the conformity assessment process. The MDR requires stricter criteria for designation and oversight of Notified Bodies to ensure consistency and reliability in the assessment process.

8. Transitional Period: There was a transition period for manufacturers to comply with the MDR. Devices certified under the MDD could continue to be placed on the market until May 26, 2024, if the MDD certificate remained valid. However, for new devices, the MDR requirements are applied immediately after implementation.

9. Legacy Devices: After the transition period, devices that were certified under the MDD and placed on the market could still be used, provided they continue to meet their intended purpose and do not compromise patient safety. However, any modifications to these devices may trigger the need for MDR compliance.

It's important for manufacturers, importers, distributors, and other stakeholders in the medical device industry to understand the new requirements outlined in the MDR and ensure compliance to continue marketing and using medical devices in the EU market. The transition involves comprehensive changes, including adjustments to processes, documentation, and quality management systems to align with the new regulation. It's recommended to consult with legal experts and regulatory consultants to navigate the transition successfully.

IZiel team of specialists and quality professionals look forward to support more medical device companies to file their devices under the MDR 2017/745.

[easymedicaldevice]

What is happening during this transition period? Call for MDR transition extension and Expert Panel handover. ⁠ ⁠ https://podcast.easymedicaldevice.com/173/⁠ ⁠ #medicaldevicepodcast #medicaldevice #medicaldevices #regulatoryaffairs #easymedicaldevice #regulatorycompliance #compliance #meddevice #iso13485 #eumdr2017745 #eumdr #mdr2017745 #ivdr #ivdr2017746 #notifiedbody #qualitymanagement #qualitymanagementsystem #regulation #regulations #qualitysystem #medtech #podcast #podcasting #podcaster #podcastinterview #podcastshow https://www.instagram.com/p/Cbr4ye1sJ77/?utm_medium=tumblr

[technicaldr]

Healthcare providers to control all clinical content of the patient record

Turn health data into actionable, cost-saving strategies

oday’s healthcare challenges are no mystery. Hospitals and health systems are navigating the transition to value-based care while continuing to rely on traditional fee-for-service reimbursement models. Uncertainty about the future of health care in the United States is making this shift even more complex as organizations seek a path forward that conquers both known (and unknown) challenges ahead.

  The standard advice heard across the industry is to “leverage data,” but how does a health system do this? Every healthcare delivery network in the country is rich with data, but how can this resource be applied for each of your care settings, clinicians and provider groups, payers and reimbursement models, and shifting populations?

  Ensuring high quality patient care and outcomes while balancing financial realities in an evolving market requires a robust data analytics solution—one that can handle the breadth and complexity of health care today without an army of data analysts to make it work.

The 3M Performance Matrix Platform is a data analytics and performance management solution that combines 3M Health Information Systems’ decades of coding and risk-adjustment experience with the data processing power of Verily, an Alphabet company. The platform simultaneously analyzes performance in managing populations throughout your network across all visits, episodes of care and disease cohorts to:

  Automatically identify the root causes of quality issues and excess costs to strengthen performance

Prioritize system-wide problem areas using advanced intelligent data processing power Work with experienced professionals to drive sustainable behavior change and process improvement

With Verily’s big data computing power, the Performance Matrix platform applies 3M’s risk adjustment methodologies and performance measures to all available data. It then mines this enriched data to identify and prioritize key problem areas. Rather than deploying teams of data analysts, the technology does the work for you.

  Using Verily’s analytics engine and 3M’s real-world, proven methodologies, the platform helps improve performance by focusing on areas and interdependencies of preventable clinical and financial issues that stem from:

Under- and over-utilization of services or care settings

Avoidable care, such as readmissions and complications

Unnecessary costs

Post-acute services

  3M Performance Matrix analyzes aggregated data against dozens of performance measures to identify and describe the most impactful problem areas. This combination of problem prioritization and analysis helps you focus on what can be fixed, and done differently, going forward. 3M Health Information Systems

Hyland Healthcare’s enterprise imaging

Hyland Healthcare’s suite of enterprise imaging solutions allow healthcare providers to control all clinical image content—including images from specialty departments. When integrated with a clinical imaging system or EHR, clinicians and staff can view medical images in the context of the patient record from within those familiar systems.

  Eliminating departmental imaging silos improves clinical workflows, strengthens security of protected health information (PHI), enhances disaster recovery, and eases the burden of building and supporting multiple clinical imaging interfaces to the EHR. The following are core components of Hyland Healthcare’s enterprise imaging portfolio.

Acuo VNA

The Acuo Vendor Neutral Archive (VNA) provides standards-based enterprise access to medical images regardless of viewing application, offering independence from proprietary archives, and streamlining clinical workflows.

  The solution leverages technologies to support the management and sharing of medical images across the enterprise and beyond, allowing providers to assemble a comprehensive image-enabled patient record.

  With on-site, cloud, and hybrid deployment options, Acuo VNA supports business continuity and disaster recovery strategies while providing a platform for clinical content integration, interoperability, and exchange.

NilRead

NilRead, a multi-specialty, zero-footprint enterprise viewer, provides a universal vendor-independent platform for accessing a full range of DICOM and non-DICOM image data. Integrating seamlessly with most EHR, PACS, or VNA, NilRead identifies and ingests images from virtually any departmental archiving solution—whether dermatology JPEGs, data-intensive virtual pathology slides, or radiology DICOM files.

  This scalable solution is based on a zero footprint, web-based architecture, meaning only a browser is needed to launch the application. There is no software or plug-ins and images never reside on the workstation. NilRead runs on any web-enabled mobile device, tablet, or PC, providing clinicians with constant access to medical images and remarkable tools to enable collaboration across the enterprise.

PACSgear

PACSgear solutions complete the enterprise imaging framework by allowing providers to capture a variety of documents, film, photos, video, and other media and integrate them with any EHR, VNA, or PACS. Hyland Healthcare’s ModLink software uses DICOM Structured Report or HL7 measurement data from ultrasound, DEXA, and CT devices to auto-populate reports in voice recognition systems. Meanwhile, ImageLink worklist solution manages HL7 to DICOM MWL mappings, facilitating Integrating the Healthcare Enterprise (IHE) workflow for interoperability with existing PACS.

PACSgear connectivity offerings:

PACS Scan, PACS Scan Mobile, PACS Scan Film, PACS Scan Web, EHR Gateway, ModLink, Media Writer, Gear View QC, MDR Video – Touch, ScopeCap, DICOM Box, and Image Link. Hyland Healthcare

Alliance Community Hospital first MEDITECH customer to deploy CommonWell Services

MEDITECH, an Enterprise Health Record (EHR) vendor and Contributor Member of CommonWell Health Alliance, has deployed CommonWell interoperability services at Alliance Community Hospital (ACH). The capabilities will enable ACH, a non-profit hospital serving the residents of Alliance, OH, to exchange patient information seamlessly for improved patient care and quality outcomes.

  MEDITECH is the first EHR vendor in CommonWell to deploy the Argonaut Project’s FHIR specifications to customers for the purpose of document exchange, providing near real-time access to a participating patient’s data. Embedded directly into the MEDITECH EHR, these CommonWell services include patient enrollment capabilities and C-CDA exchange, opening the door for more comprehensive sharing of discrete segments of data in the future, such as medication and allergy data.

  Today, more than 9,300 provider sites are Live on CommonWell services across the nation, and more than 30 million individuals are enrolled..

  Accelerate and improve patient care anytime, anywhere with secure mobile app AlertView

AlertView, the mobile application developed by Novarad Healthcare Enterprise Imaging, was created to accelerate healthcare by notifying physicians via text message that reports and findings are ready for review.

  AlertView makes healthcare more efficient by eliminating unnecessary delays in the review of imaging reports. The AlertView app instantly sends a text message to referring physicians, radiologists, or cardiologists alerting them that a report is ready for review. No matter where they are, they can review with one click on the text message, and have this instantly shared with other medical care professionals. This type of mobile communication and collaboration improves patient outcomes while minimizing disruptions for primary care physicians and hospital staff.

  The app’s features include secure login with TouchID, a dynamic patient list to enable quick searches, extensive filtering including modality and time filters, a convenient basic report view along with an in-depth full report view, display of all key images in the study, and enhanced data security through deep linking

Technical Dr. Inc.'s insight:

Contact Details :

inquiry@technicaldr.com or 877-910-0004 www.technicaldr.com

[topbreakingnews]

Drug-Resistant TB on the Rise in These Four Counties - MedPage Today

New Post has been published on https://www.topbreaking.news/health/drug-resistant-tb-on-the-rise-in-these-four-counties-medpage-today.html

Drug-Resistant TB on the Rise in These Four Counties - MedPage Today

Times of India

Drug-Resistant TB on the Rise in These Four Counties MedPage Today Cases of multidrug-resistant and extensively drug-resistant tuberculosis are expected to increase in four countries with a high burden of multidrug-resistant tuberculosis from 2000 to 2040, reported researchers. According to findings from a … Drug Resistant TB Is Predicted To Steadily Spread In 4 CountriesNPR CDC Researchers Predict Continued Spread Of MDR-TB In 4 Countries Without Prevention, Treatment InterventionsKaiser Family Foundation Researchers Predict Increase in Drug-resistant TBYahoo News

all 10 news articles »

Read more…

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[operonstrategist-blog]

EU MDR Transition extension part 1

Let's learn about the MDR Transition Extension and its significance in this brief. . Let’s Connect! 🤩🤩 🤝

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Have you had a great experience with Operon Strategist? Let us know is the comment is below!

[izielhealthcare]

MDR vs. MDD: 13 Key Changes

All Those involved in medical device field must be thorough with MDD (Medical device directive) and now familiar and knowledgeable with new regulation by EU MDR (Medical device regulations) Like MDR was made to replace MDD and then it was applicable to EU and UK, however situation changed for UK after BREXIT. We will restrict our blog to MDD Vs. MDR and what major changes are there which manufacturer or distributor must take care if they need to continue business in EU countries. (With Brexit even business with UK will also be possible if MDR is followed if certain aspects are taken care for administrative purpose)

 Though one can say that MDR is not radically different from MDR but lot of changes have happened in MDD clauses and all manufacturers will have to do work for those as this is now effective after May 5, 2021. Though MDR has become effective, those who already have MDD can take advantage of various extensions extended and latest extension for certain device comes as late as 27th May 2025.

 Administrative hassles, and creation of notified bodies and Covid 19 pandemic caused lot of delay.

Timeline:

 Certificate issued under MDD becomes void if not expired, means last date for placing device in market as per MDD is 26th May 2024. Last date for putting device into service as per MDD is 26th May 2025. If your certificate is expired in 2020 or 2021, MDR is an advisable answer.

There are no devices grandfathered in MDR. So, all the manufacturer who were under grand fathered status under MDD need to transit to MDR now itself.

Even though, as suggested above you can continue to market as late as 26th May 2025, there are lot of restrictions.

 1.       No substantial design changes are acceptable to notified bodies.

2.       Device must remain in compliance to the state-of-the-art requirement, including EU issued common specification and recognised standards.

3.       PMS (Post market surveillance) requirement must be implemented along with PMCF (Post market clinical follow up) or justification is required why no PMCF.

4.       Registration requirement for all economic operators need completion. Manufacturer must ensure that quality agreement is in place for Authorised representative, importer, and distributor.

 In above situation it is advisable to hire MDD to MDR consultants for gap assessment and transition preparation. These consultants can take up CER reviews as well as training also. Certain aspects of future job can be accomplished through MDR consultants also as interpretation of various clauses of MDR need an expert and experienced eye.

 1.       MDD vs. MDR: Let us understand some verbatim changes so significance can be understood, and detailing can be worked out.

2.       MDR is almost four times larger than MDD.

3.       The word “Safety” appears 240 times against only forty times in MDD. This signifies stress and approach and required technical documentation changes.

4.       Stress on conducting global impact assessment and to remain in compliance thereafter.

5.       New safety and performance requirements which identifies new condition need to be addressed. (Like, CE mark under MDD and product re-certification)

6.       UDI implementation.

7.       MDD scope did not encompass medical purpose of medical device and AIMDD, both are part of MDR.

8.       Definition of medical device is broadened to include non-medical and cosmetic devices which were not previously in scope of regulation. (Ex, contact lens, liposuction equipment)

9.       More in depth clinical data and evaluation.

10.   Reporting of all incidents, serious incidents including death now needs reporting in EU portal as centralised data for better access for patient. Non serious incident reporting time reduced from 30 days to 15 days.

11.   Companies undergoing transitions shall have to pay more attention on core processes of QA, risk management and post market expectations. These all must be aligned to new requirement.

12.   Reclassification of many medical devices will be required to higher risk class. New classification for reusable surgical devices will require notified body oversight. (Notified body come in picture)

13.   IVD are classified now into four risk classes. 90 % of them will now come under purview of notified bodies as against earlier only 10 %.

 MDR is effective now but certain medical devices compliant with MDD/AIMDD can continue till 26th May 2024 provided there is no significant change in device and intended purpose.

 Looking at above 13 changes and maintain the timeline and continuity of business, MDD to MDR consultant or MDR consultant support is advisable.

 Our “ONE-STOP COMPLETE SOLUTION” include –

 ·         Gap Assessment

·         Technical File Preparation

·         QMS Documentation

·         Expert Review & Recommendations

·         European Authorized Representative (EC REP)

·         EUDAMED

·         Mock Audits & Trainings

·         PRRC Services

·         Clinical Evaluation Plan & Report

·         Software Validation

 IZiel team of specialists and quality professionals look forward to support more medical device companies to file their devices under the MDR 2017/745.