• Login
    • Join
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Exclusives
    • Manufacturing
    • Markets
    • Top 10
    • Buyers' Guide
    • Events
    • Microsites
    • More
  • Magazine
  • News
  • Exclusives
  • Manufacturing
  • Markets
  • Top 10
  • Buyers' Guide
  • Events
  • Microsites
  • Current & Past Issues
    Features
    Departments
    Columns
    Editorial
    Digital Edition
    Subscribe Now
    Advertise Now
    Editorial Guidelines
    eNewsletter Archive
    eBook
    Top Features
    Innovation Iteration: Latest Advancements in Design & Prototyping

    Robot Recharge: Orthopedic Surgical Robotics Update

    Fine Print: Examining 3D Printing for Orthopedics

    Pulsed Electrochemical Machining: Achieved Through Chemistry

    Packaging and Sterilization Update for Orthopedic Devices
    Breaking News
    Certifications
    Clinical Trials
    Device Approvals & Patents
    Financial & Deals
    International
    Market Data & Trends
    OEM News
    Orthopedic Innovators
    People
    Product & Service Releases
    Products
    Quality, Recalls & Risk
    Regulatory & Legal
    Supplier & Contract Mfg.
    Live From Shows
    Top News & Features
    FDA Clears Anika Therapeutics' X-Twist Knotless Fixation System

    Paragon 28 Rolls Out TenoTac 2.0 Hammertoe and Soft Tissue Repair

    Cionic Expands Scientific Advisory Board

    First Surgeries Performed Using Globus Medical's Excelsius3D

    Envista To Acquire Osteogenics
    3-D Printing/Additive Mfg.
    Assembly & Automation
    Biocompatibility & Testing
    Clean Room
    Coatings/Surface Modification
    Contract Manufacturing
    Design
    Extrusion
    Finishing
    Forging & Casting
    Instruments, Cases & Trays
    International/Offshoring
    Laser Processing
    Materials
    Machining & Tooling
    Molding
    Packaging & Sterilization
    Prototyping
    Research & Developement
    Software & Quality
    Staffing, Training & Prof. Dev.
    Supply Chain

    Denise Pedulla Appointed as Chief Legal Officer at Conformis

    ODT's Most-Read Stories This Week—May 14

    Steven Haddad Joins Extremity Medical as Chief Clinical Officer

    FDA OKs Accelus' FlareHawk TiHawk11 Interbodies

    Gary Fischetti Joins Conformis’ Board of Directors
    Biologics
    Bracing/Prosthetics
    Extremities
    Imaging
    Instruments
    Large Joint
    MIS/Robotics
    Spine/Neurology
    Trauma/Sports
    Top Markets
    It’s All About the Data for Supply Chain and Inventory Management

    Minimizing Risks in Minimally Invasive Surgery

    Giving Athletes Their Lives Back with Better Knee Braces

    ODT Forum '22 is Another Successful Orthopedic Tech Conference

    5 Ways AI Will Impact Orthopedic Surgery's Future
    Companies
    Categories
    Company Capabilities
    White Papers
    Add New Company
    International Buyers Guide Companies
    Medbio LLC

    Master Bond Inc.

    Orchid Orthopedic Solutions

    Fischer Connectors Inc.

    Tegra Medical
    Industry Events
    Webinars
    • Magazine
      • Current & Past Issues
      • Features
      • Editorial
      • Departments
      • Columns
      • Digital Edition
      • eNewsletter Archive
      • Editorial Guidelines
      • Subscribe Now
      • Advertise Now
      • eBook
    • Breaking News
    • Buyers' Guide
      • Companies
      • Categories
      • Company Capabilities
      • White Papers
      • Add Your Company
    • Manufacturing
      • 3-D Printing/Additive Mfg.
      • Assembly & Automation
      • Biocompatibility & Testing
      • Clean Room
      • Coatings/Surface Modification
      • Contract Manufacturing
      • Design
      • Extrusion
      • Finishing
      • Forging & Casting
      • Instruments, Cases & Trays
      • International/Offshoring
      • Laser Processing
      • Materials
      • Machining & Tooling
      • Molding
      • Packaging & Sterilization
      • Prototyping
      • Research & Developement
      • Software & Quality
      • Staffing, Training & Prof. Dev.
      • Supply Chain
    • Markets
      • Biologics
      • Bracing/Prosthetics
      • Extremities
      • Imaging
      • Instruments
      • Large Joint
      • MIS/Robotics
      • Spine/Neurology
      • Trauma/Sports
    • Top 10
    • Online Exclusives
    • Slideshows
    • Videos
    • Webinars
    • Events
      • Industry Events
    • Live from Show Event
    • About Us
      • About Us
      • Contact Us
      • Privacy Policy
      • Terms of Use
      • Advertise With Us
    Columns

    Four Questions to Help You Avoid Losing a CE Mark

    ...

    Four Questions to Help You Avoid Losing a CE Mark
    Related CONTENT
    • Tyber Medical Receives FDA Clearance for Expanded Line of Anatomical Plating Systems
    • Revisiting Five Years of ODT Emerging Companies
    • EU Trademark Court of Appeals Upholds Ruling in Favor of CoorsTek
    • CE Mark, FDA Breakthrough Device Designation Granted for DDD Tech
    • SeaSpine Earns FDA Nod for 7D Surgical Percutaneous Spine Module
    Patrick Biggins, Quality Assurance & Manufacturing, Musculoskeletal Clinical Regulatory Advisers LLC08.09.16
    A Clinical Evaluation Report (CER) is part of the process through which a medical device is certified or recertified to carry the CE mark; it applies to all device classifications. A company may have complied with the quality aspects of its ISO 13485 certification, but it also needs to comply with the technical documentation required by the Medical Device Directive (MDD), which includes the CER.

    Every five years, a company’s Notified Body (NB) formally reviews the CE mark status for a medical device distributed in Europe. For many medical devices, that means CERs must be submitted now. Recently, NBs have intensified their scrutiny of CERs. This has left many medical device companies scrambling to remediate their CERs before the five-year window expires and jeopardizes the CE mark status of their product.

    CERs have always been required as part of CE mark recertification. NB-MED/2.5.1/Rec5 (2010), titled “Technical Documentation,” notes (in essence), “If you are going to create a technical file or a design dossier, you must have a CER; here is the guidance for it.” (NB-MED/2.5.1/Rec5 can be found at: http://bit.ly/2016cer1. A recommendation for the evaluation of clinical data, titled, “Evaluation of Clinical Data” (NB-MED/2.7/Rec3 [2010]), can also be found at the same URL.)

    Overall, companies have been submitting satisfactory CERs for high-risk (Class III) devices. However, CERs submitted for lower-risk devices have, in general, not been so rigorous. Those CERs, although not rejected by the NBs, did not completely or correctly follow the guidance for CER submissions as described in MEDDEV 2.7.1, Rev. 3 (Clinical evaluation: Guide for manufacturers and notified bodies [2009]; http://bit.ly/2016cer2).

    1. Why did the NBs accept subpar CER submissions in the past?
    Simply put, and for reasons not completely known, NBs were not enforcing the content and format of lower risk product CERs. The authorities overseeing the NBs are now requiring that their NBs ensure all medical devices in the European market wanting to receive or retain a CE mark have a compliant CER.

    2. Why is the push for stricter compliance occurring now?
    ISO 14971 (Medical devices—Application of risk management to medical devices) underwent a major revision in 2012 and became a European Norm (EN). An EN is a law in Europe, which means it must be followed. An EN ISO is more enforceable than an ISO. The risk management changes in EN ISO 14971:2012, based on the Medical Device Directive (MDD), are also reflective on the clinical risk evaluations required in the CER. EN ISO 14971:2012 has given CERs more visibility. The EN ISO 14971:2012 standard may be purchased at www.iso.org, or from any organization licensed to sell the standard.

    With the above in mind, be aware that companies might have two different challenges:
    • A risk management process that, according to EN ISO 14971:2012, is not meeting the standard
    • A CER that is not meeting the directive, which is evaluated by the MEDDEV document

    3. Why the urgency around CER submissions?
    Many companies that received their CE mark certification before 2012 have begun submitting revised CERs as part of the five-year review cycle for their products. They have been surprised to find their NBs are rejecting their submissions due to noncompliance with MEDDEV guidance, even though past submissions had been accepted. Without a compliant CER, the CE mark for a product can be delayed and even withdrawn, resulting in a company no longer being able to sell that product in Europe (or any member states of the European Union).

    4. What can my company do now?
    A. Obtain and review the relevant CER guidance, and make sure it is completely understood. If there are any questions, seek assistance from an expert.
    B. Conduct a gap analysis to determine whether or not your CER meets the requirements of the MEDDEV.
    C. Identify any noncompliant issues.
    D. Fix those issues to bring the CER into compliance with the MEDDEV. If an existing CER is highly noncompliant, writing a new CER may be preferable to amending the existing CER.
    E. Create a standard operating procedure on how to write CERs, or update the existing one, and include a template in the appendices.

    Conclusion
    The European Commission (EC) guidance for CERs is similar in concept to the type of guidance issued by the U.S. Food and Drug Administration. The main reason NBs reject CERs is because companies submitting the CERs did not follow the guidance correctly. For example, many companies have been conducting data reviews of existing data only, and not the entire analysis as required by the guidance?

    If NB regulators cannot follow how a submission flows and determine whether it is meeting the guidance, they will inform the company and delay the CE marking.

    Although some companies may understand the guidance, they may not have the resources to comply with it; CERs are very resource-intensive. If that is the case, companies should seek external resources (e.g., agencies or consultants) experienced in submitting CERs. External resources can be used, in part or in whole, to
    research and write CERs.

    When selecting an external resource, ensure that resource can do more than simply identify areas of CER noncompliance. A good consultant will not only help a company understand where the process gaps are, but will also help it develop and implement a clear plan to resolve those gaps and improve its overall process. 

    Resources for CER Guidance
    1. “Technical Documentation” (NB-MED/2.5.1/Rec5 [2010]) & “Evaluation of Clinical Data” (NB-MED/2.7/Rec3 [2010]): http://bit.ly/2016cer1

    2. Complete list of all the European Commission (EC) MEDDEV guidance:
    http://bit.ly/2016cer2

    3. ISO Standards (must be purchased): www.iso.org (or any organization licensed to sell the standard)



    Patrick Biggins is vice president of quality assurance and manufacturing at the Musculoskeletal Clinical Regulatory Advisers LLC (MCRA). He has over 20 years of experience in the area of quality systems and manufacturing, beginning as a quality engineering manager. Biggins is an expert at Quality Management Systems, specifically in the areas of corrective and preventive action (CAPA), customer complaints, design control (including design change), and production and process control, including process validations based on the GHTF guidance. 
    Suggested For You
    Tyber Medical Receives FDA Clearance for Expanded Line of Anatomical Plating Systems Tyber Medical Receives FDA Clearance for Expanded Line of Anatomical Plating Systems
    Revisiting Five Years of ODT Emerging Companies Revisiting Five Years of ODT Emerging Companies
    EU Trademark Court of Appeals Upholds Ruling in Favor of CoorsTek EU Trademark Court of Appeals Upholds Ruling in Favor of CoorsTek
    CE Mark, FDA Breakthrough Device Designation Granted for DDD Tech CE Mark, FDA Breakthrough Device Designation Granted for DDD Tech
    SeaSpine Earns FDA Nod for 7D Surgical Percutaneous Spine Module SeaSpine Earns FDA Nod for 7D Surgical Percutaneous Spine Module
    Integrity Implants, Fusion Robotics Merge to Form Accelus Integrity Implants, Fusion Robotics Merge to Form Accelus
    CE Mark Granted to NuVasive CE Mark Granted to NuVasive's Pulse Platform
    Integrity Integrity's Expandable Lumbar Interbody Fusion Device Wins CE Mark
    Hensler Surgical Granted CE Certification for Bone Press Hensler Surgical Granted CE Certification for Bone Press
    FDA Breakthrough Designation Awarded to Lumbar Nucleus Replacement System FDA Breakthrough Designation Awarded to Lumbar Nucleus Replacement System
    Rugby Study Identifies New Method to Diagnose Concussions Using Saliva Rugby Study Identifies New Method to Diagnose Concussions Using Saliva
    EDGe Surgical Receives CE Mark for EDG Ortho 65mm Electronic Depth Gauge EDGe Surgical Receives CE Mark for EDG Ortho 65mm Electronic Depth Gauge
    Mainstay Medical Launches ReActiv8 in Australia Mainstay Medical Launches ReActiv8 in Australia
    Empirical Spine Empirical Spine's LimiFlex Device Granted Breakthrough Designation Status
    Orthopediatrics Tops 500 Scoliosis Cases Milestone Orthopediatrics Tops 500 Scoliosis Cases Milestone

    Related Content

    • Extremities
      Tyber Medical Receives FDA Clearance for Expanded Line of Anatomical Plating Systems

      Tyber Medical Receives FDA Clearance for Expanded Line of Anatomical Plating Systems

      The line includes over 73 different indication-specific anatomical plating families.
      Tyber Medical 09.08.21

    • Revisiting Five Years of ODT Emerging Companies

      Revisiting Five Years of ODT Emerging Companies

      A five-year checkup on the orthopedic companies making their way into specialized markets.
      Sean Fenske, Michael Barbella, & Sam Brusco, ODT Editors 08.17.21

    • Materials
      EU Trademark Court of Appeals Upholds Ruling in Favor of CoorsTek

      EU Trademark Court of Appeals Upholds Ruling in Favor of CoorsTek

      Reaffirms CoorsTek’s ability to manufacture and market their CeraSurf-p 'pink' implantable ceramic hip components.
      08.04.21


    • Spine/Neurology
      CE Mark, FDA Breakthrough Device Designation Granted for DDD Tech

      CE Mark, FDA Breakthrough Device Designation Granted for DDD Tech

      Spinal Stabilization Technologies' PerQdisc device replaces the nucleus pulposus of the intervertebral disc in the L1 - S1 spinal region.
      PR Newswire 08.03.21

    • Imaging | Spine/Neurology
      SeaSpine Earns FDA Nod for 7D Surgical Percutaneous Spine Module

      SeaSpine Earns FDA Nod for 7D Surgical Percutaneous Spine Module

      Uses visible light to create a 3D image for surgical navigation in seconds.
      GlobeNewswire 07.09.21


      Trending
      • GE Additive And Orchid Partner To Advance Scalable Metal 3D Printing | Orthopedic Design Technology
      • Orthotic Brace Suppliers Convicted In $6.5M Fraud Scheme | Orthopedic Design Technology
      • Orthotic Brace Suppliers Convicted in $6.5M Fraud Scheme
      • Minimizing Risks In Minimally Invasive Surgery | Orthopedic Design Technology
      • Alex Gorsky To Step Down As J&J CEO In 2022 | Orthopedic Design Technology
      Breaking News
      • FDA Clears Anika Therapeutics' X-Twist Knotless Fixation System
      • Paragon 28 Rolls Out TenoTac 2.0 Hammertoe and Soft Tissue Repair
      • Cionic Expands Scientific Advisory Board
      • First Surgeries Performed Using Globus Medical's Excelsius3D
      • Envista To Acquire Osteogenics
      View Breaking News >
      CURRENT ISSUE

      March/April 2022

      • Innovation Iteration: Latest Advancements in Design & Prototyping
      • Robot Recharge: Orthopedic Surgical Robotics Update
      • Fine Print: Examining 3D Printing for Orthopedics

      Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
      You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

      • About Us
      • Privacy Policy
      • Terms And Conditions
      • Contact Us

      follow us

      Subscribe
      Nutraceuticals World

      Latest Breaking News From Nutraceuticals World

      GOED Creates Infographic Highlighting Omega-3 Health Claims Approved in Europe
      Kyowa Hakko Appoints Dr. Colin Hill to Immuse Scientific Advisory Board
      Expert Consensus Statement: Diet is Best Primary Intervention to Achieve Diabetes Remission
      Coatings World

      Latest Breaking News From Coatings World

      Teknos Receives EcoVadis Gold Medal for Sustainability Performance
      AkzoNobel and Partners Team Up to Hack Carbon Reduction Challenges
      Five PPG Facilities in Ohio Recognized for Sustainability, Health, Safety Practices
      Medical Product Outsourcing

      Latest Breaking News From Medical Product Outsourcing

      Iterative Scopes Expands its Senior Leadership Team
      Viz.ai Raises $100 Million in Series D Funding
      FDA Clears Arterys' AI Mapping and Quantification Tools
      Contract Pharma

      Latest Breaking News From Contract Pharma

      Piramal Pharma Solutions New API Plant in Canada Now Online
      MG America Appoints Claudio Radossi as President
      Catalent Invests $175M to Expand Mfg. Capabilities at Winchester, KY
      Beauty Packaging

      Latest Breaking News From Beauty Packaging

      Authentic Beauty Concept Launches Second-Generation ‘Refill Bar’
      HASK Beauty Enters Exclusive Partnership with Amazon
      Garance Doré Launches Made in France Skincare Line
      Happi

      Latest Breaking News From Happi

      Silab Implements Biodiversity Conservation Project
      Indie Beauty Brand i-On Skincare Releases New Skin Emulsion, AI Diagnostic Tool
      Estée Lauder Companies' New Research on Oxidative Damage, Skin Barrier Function & Hyperpigmentation
      Ink World

      Latest Breaking News From Ink World

      Nazdar Celebrates 100 Years with a New Look
      hubergroup Chemicals Exhibits at Paint India for First Time
      Award for Sustainability: Evonik Receives Platinum Rating Again
      Label & Narrow Web

      Latest Breaking News From Label & Narrow Web

      Specialty announces move to new facility
      Mark Andy hosts dealer's open house in Warsaw
      Nazdar celebrates 100th anniversary with refreshed brand identity
      Nonwovens Industry

      Latest Breaking News From Nonwovens Industry

      3M to Expand in Nebraska
      Nicely Offers Nonwoven Slitters, Winders
      'Right' Hygiene Conference to be Held in June
      Orthopedic Design & Technology

      Latest Breaking News From Orthopedic Design & Technology

      FDA Clears Anika Therapeutics' X-Twist Knotless Fixation System
      Paragon 28 Rolls Out TenoTac 2.0 Hammertoe and Soft Tissue Repair
      Cionic Expands Scientific Advisory Board
      Printed Electronics Now

      Latest Breaking News From Printed Electronics Now

      Evonik Launches New Processing Aids for PV Wafer Cutting
      NREL Creates Highest Efficiency 1-Sun Solar Cell
      eMagin Wins People’s Choice Award at Display Week 2022

      Copyright © 2022 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

      AD BLOCKER DETECTED

      Our website is made possible by displaying online advertisements to our visitors.
      Please consider supporting us by disabling your ad blocker.


      FREE SUBSCRIPTION Already a subscriber? Login