TwitterLinkedin

Contact Us

  • Biopharma Excellence
  • News & Events
    • Industry News Articles
    • Press Releases
    • Webinars
    • Events
    • Blog
    • Podcasts
  • Resource Library
    • Thought Leadership
    • Fact Flyers
    • Case Studies
    • White Papers
    • Webinars
    • Infographics
    • Video & Animation
  • Careers
    • Life at PharmaLex
    • Current Opportunities
  • Training
Top Bar
Search
PharmaLex Logo
MENUMENU
  • PharmaLex Logo
  • PharmaLex Logo
  • About UsAbout Us
    • About Us
    • Management Team
    • Corporate Social Responsibility
    • What Our Clients Say About Us
  • Our Services
    • Discovery / Non-clinical
          • Go to Discovery / Non-clinical section >>

          • Strategy and Consulting

            • Integrated Product Development
            • Market Access
            • Scientific Advice
            • Statistics and Data Sciences
            • Toxicology Services
    • Clinical Development
          • Go to Clinical Development section >>

          • Strategy and Consulting

            • Clinical Program Development
            • Scientific Advice
            • Statistics and Data Sciences
          • Regulatory Affairs

            • Clinical Trial Applications
            • Global Procedure Management
            • Health Authority / Agency Interaction
            • Regulatory Operations
          • Pharmacovigilance

            • Clinical Trial Safety Support
            • Pharmacovigilance Consulting
          • Quality

            • GxP Services
            • Interim / Contract QA
            • Quality Management Systems
            • Tech Transfer / Scale-up
    • Authorization / Approval
          • Go to Authorization / Approval section >>

          • Strategy and Consulting

            • Market Access
          • Regulatory Affairs

            • CMC Services
            • Global Procedure Management
            • Health Authority / Agency Interaction
            • Marketing and Labeling Activities
            • Regulatory Operations
            • Scientific, Regulatory and Technical Writing
            • Statistics and Data Sciences
          • Pharmacovigilance

            • EU QPPV / National QPPV
            • Pharmacovigilance Consulting
          • Quality

            • Commercialization Readiness
            • Commissioning, Qualification, and Validation (CQV)
            • GxP Services
            • Interim / Contract QA
            • PAI Readiness
    • Post-approval / Maintenance
          • Go to Post-approval / Maintenance section >>

          • Strategy and Consulting

            • Market Access
          • Regulatory Affairs

            • CMC Services
            • Global End-to-End Outsourcing
            • Global Procedure Management
            • Health Authority / Agency Interaction
            • Marketing and Labeling Activities
            • Mergers and Acquisitions (M&A) Transfers
            • Regulatory Operations
            • Toxicology Services
          • Pharmacovigilance

            • EU QPPV / National QPPV
            • ICSR (Individual Safety Case Report) Management
            • Literature Monitoring & Screening
            • Pharmacovigilance Quality & Compliance
            • Signal Management
          • Quality

            • Commissioning, Qualification, and Validation (CQV)
            • GxP Services
            • Interim / Contract QA
            • Quality Management Systems
          • Medical Affairs

            • Healthcare Compliance and Medical Approval
    • Program Management
          • Go to Program Management section >>

          • Program Management

            • Global End-to-End Outsourcing
            • Global Procedure Management
            • Integrated Product Development
            • Mergers and Acquisitions (M&A) Transfers
    • Featured Expertise
          • Industry Expertise

            • Biopharmaceuticals
            • MedTech Services
          • Service Expertise

            • ATMP / Cell and Gene Therapy
            • COVID-19 Support
            • GxP Services
            • Market Access
            • Pharmacovigilance Consulting
            • Post-Brexit Regulatory Support
            • Statistics and Data Sciences
            • SMARTPHLEX - technology-enabled services
  • Global ReachGlobal Reach
  • Contact usContact us
  • News & Events
    • Industry News Articles
    • Press Releases
    • Webinars
    • Events
    • Blog
    • Podcasts
  • Resource Library
    • Thought Leadership
    • Fact Flyers
    • Case Studies
    • White Papers
    • Webinars
    • Infographics
    • Video & Animation
  • Careers
    • Life at PharmaLex
    • Career Opportunities
  • Training
Home > News & Events > Blog > Next Steps for EUDAMED implementation within MDR

Next Steps for EUDAMED implementation within MDR

Next Steps for EUDAMED implementation within MDR

By Jean Boudaud, director and head of medical devices/IVD, Australia, at PharmaLex

When the Medical Devices Regulation (MDR) came into force in May 2017, it was missing a key operational component to allow full compliance of the new regulation: the European Database for Medical Devices (EUDAMED).

EUDAMED supports operational implementation of both the MDR (which replaces the Medical Devices Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD) and the In Vitro Diagnostics Regulation (IVDR), with the goal of improving transparency and availability of information (including with the public) regarding medical devices available on the EU market. Its operation is critical to more current ways of regulating medical devices, through adoption of a complete lifecycle approach to the management of device safety and reinforcement of postmarket  surveillance systems.

As it stands today, of the six interconnected modules planned within EUDAMED, only three are available. For the past couple years (and until EUDAMED becomes fully operational), companies have therefore been unable to comply with all aspects of the new regulations. Currently available modules are:

  • Actor registration — available since December 2020, enabling economic operators to obtain an actor identifier/single registration number
  • UDI/Devices registration – available since October 2021, which allows easier traceability of medical devices. This capability is entirely new to Europe, although UDIs have been in place in other regions for some time. Manufacturers will have to implement this UDI system for their products based on class and on use scenarios
  • Notified Bodies and Certificates – also available since October 2021, through which notified bodies register any information regarding certificates issued, suspended, reinstated, withdrawn, or refused and other restrictions imposed on these certificates.

The three modules yet to be completed are:

  • Clinical Investigations and performance studies
  • Vigilance and post-market surveillance
  • Market Surveillance

Just recently, the EU commission released its target timelines for implementation. Although past experience would suggest current timelines are overly optimistic, it is expected that the database will be fully released by Q4 2022. The database will then be subject to an independent audit, the results of which will be presented to the Medical Devices Coordination Group (MDCG). From there, progressive enforcement of the use of all modules is expected until Q2 2025. Mandated application of the database will be communicated by the commission through a notice in the Official Journal.

The use of EUDAMED remains voluntary until full implementation.  However, manufacturers and economic operators are encouraged to start using all modules available to them and ensure all changes to their quality systems are implemented immediately (e.g. postmarket and UDI systems).

In times of disruptive regulatory changes, it’s essential to stay ahead of all regulatory updates that can affect your business. Find out more about how PharmaLex can help you stay ahead of changes and discover PharmaLex’s assessment tool to support your transition to MDR.

Related Links:

Contact us today to find out more about our MDR readiness assessment tool
START YOUR FREE ASSESSMENT
Hear from one of our experts in our latest MDR Podcast
LISTEN TO PODCAST
Related posts
Is quality documentation an asset or a burden in regulatory affairs?
Is quality documentation an asset or a burden in regulatory affairs?
6th April 2022
Navigating the impact of the IVDR on marketed products
Navigating the impact of the IVDR on marketed products
24th March 2022
Minimizing risk during the transport of medicinal products
Minimizing risk during the transport of medicinal products
21st March 2022
How Advanced Therapeutic Mergers & Acquisitions Impact Negotiations and Integration
How Advanced Therapeutic Mergers & Acquisitions Impact Negotiations and Integration
26th February 2022
Planning for Post-Emergency Use Authorization (EUA) for Medical Devices and IVDs
Planning for Post-Emergency Use Authorization (EUA) for Medical Devices and IVDs
24th February 2022
Navigating New Digital Regulatory Requirements
Navigating New Digital Regulatory Requirements
7th February 2022
Recent Blogs
  • Is quality documentation an asset or a burden in regulatory affairs?
    6th April 2022
  • Navigating the impact of the IVDR on marketed products
    24th March 2022
  • Minimizing risk during the transport of medicinal products
    21st March 2022
  • Next Steps for EUDAMED implementation within MDR
    7th March 2022
  • How Advanced Therapeutic Mergers & Acquisitions Impact Negotiations and Integration
    26th February 2022
  • Planning for Post-Emergency Use Authorization (EUA) for Medical Devices and IVDs
    24th February 2022
Recent News
  • Addressing Limitations of Sterility Testing
    9th May 2022
  • Are virtual audits sustainable post-pandemic?
    6th May 2022
  • Orphan Drug Designation: Securing the Significant Benefits
    28th March 2022
  • PharmaLex expands pricing & reimbursement and health economics platform with EBMA Consulting merger
    9th March 2022
  • PharmaLex extends reach to Japan, East Asia and Southeast Asia with Ascent Development Services merger
    8th February 2022
  • Virtual Audits: To be, or not to be, that is the question
    26th January 2022
Upcoming Events

September 28 - May 29th, 2022

NLS DAYS 2022

Visit us at booth X51

Biopharma Excellence Website Image

PharmaLex Brings You Biopharma Excellence

Biopharma Excellence is a fusion of three scientific powerhouses, PharmaLex, ERA Consulting and Biopharma Excellence – all under the PharmaLex brand. This global team of scientific, regulatory and commercial professionals provide strategic product development and proactive regulatory services to developers of biopharmaceuticals, cell and gene therapies, monoclonal antibodies (MABs), vaccines and biosimilars.

Visit Website
USEFUL LINKS
  • Home
  • Contact us
  • Imprint
  • Data Protection
  • Terms and Conditions
RECENT TWEETS
PharmaLexGLOBALPharmaLex@PharmaLexGLOBAL·
20 May

PharmaLex is excited to be supporting the #ARCSannualconference again this year. Be sure to join their sessions and visit our team at stand 44.

Find out more: https://lnkd.in/g6fbC2kr

COVID-19 NEWSLETTER SIGN UP

SIGN UP NOW

WHAT OUR CLIENTS SAY
  • What was especially important to me was their ability to get a team, with the right experience, together so quickly.

    Mid-size Biotech
    Head of Outsourcing
PharmaLex
©2022 PharmaLex GmbH. All rights reserved.

ISO9001:2015 LogoEnergie Audit LogoSGS Logo

Suspicious Emails

We are aware of a number of suspicious emails about recruitment in circulation purporting to be from PharmaLex. Emails sent by PharmaLex will originate from @pharmalex.com. Should you receive an email and are unsure as to its validity, please report it to contact@pharmalex.com.

Many thanks for your understanding.

The PharmaLex Team

    Please DO NOT send us event/conference information.
    We will not respond and these will be deleted immediately.





    Select your state:

    .
    If you do not wish to receive any communication from us, you may unsubscribe at any time.

    #AskTheExpert #TogetherBEYONDCOVID19





      Select your state:

      .
      You can unsubscribe at any time at data.protection@pharmalex.com

      If you do not wish to receive any communication from us, you can unsubscribe at any time at. Click here to view our Privacy Policy.

      #TogetherBEYONDCOVID19

      We closely monitor developments and updates surrounding the current outbreak of Coronavirus Disease 2019 (COVID-19) from official sources including the World Health Organisation and are following the guidance and direction of the governments and the local authorities. We are taking this situation very seriously and our number one priority is the safety and business continuity for our customers and colleagues. As ever, we will do everything we can to ensure that services are delivered within the required time and the trusted quality PharmaLex is known for