Getting CE Marking for Medical Devices in Europe

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The European CE Marking approval process explained step-by-step

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  • It's not that difficult if the device has study protocols that is/are approved by an IRB and studies completed demonstrate clinical efficacy. Then you make an appointment with a regulatory agency (such as MHRA in the UK) and state your case. You will know within 24hr if approved for marketing in the EU. if your device is approved for marketing you get the CE mark for use in multiple countries.
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Getting CE Marking for Medical Devices in Europe

  1. 1. The CE Marking Process for Medical Devices CE Marking: The Medical Device Approval Process in Europe Steps to obtain certification necessary to market your device in the European UnionASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  2. 2. The CE Marking Process for Medical Devices Key Topics We Will Cover: • Overview of the EU market • Overview of the Medical Device Directives • Medical Device Classification • ISO 13485 Quality Systems • Technical File Compilation • Authorized Representation Requirements • Risk Assessments • Labeling Requirements • Language Translation Challenges • Post-market SurveillanceASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  3. 3. The CE Marking Process for Medical Devices Overview of the European Union • 27 member states plus European Free Trade Association members (Norway, Switzerland, Iceland and Liechtenstein) • Population of more than 500 million people • 23 languagesASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  4. 4. The CE Marking Process for Medical Devices EU Directives Impacting Medical Devices Medical Devices (MDD) 93/42/EEC Covers the bulk of medical devices marketed in the EU Examples: orthopedic implants, heart valves, medical softwareASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  5. 5. The CE Marking Process for Medical Devices EU Directives Impacting Medical Devices Active Implantable Medical Devices (AIMDD) 90/385/EEC Covers devices that require external power sources in order to function properly Examples: pacemakers, implantable defibrillatorsASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  6. 6. The CE Marking Process for Medical Devices EU Directives Impacting Medical Devices In Vitro Diagnostics (IVDD) 98/79/EC Covers devices used for the examination of specimens taken from the human body Examples: pregnancy self-testing strips, blood glucose self-testing stripsASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  7. 7. The CE Marking Process for Medical Devices Other EU Medical Directives/Regulations These EU directives and regulations may also apply to medical devices: •Personal Protective Equipment 89/686/EEC •Low Voltage 2006/95/EC •Electromagnetic Compatibility 2004/108/EC •Blood Product Directive 2002/98/EC •Animal Tissue Use in Medical Devices 2003/32/EC •Human Tissue Products Directives 2004 & 2005 •Breast Implants Reclassification Directive 2003/12/EC •Hip, Knee, Shoulder Joint Replacement Reclassification Directive 2005/50/ECASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  8. 8. The CE Marking Process for Medical Devices Key Players in the CE Marking Process •Manufacturers and Subcontractors •Competent Authorities •Notified Bodies •Authorized Representatives •DistributorsASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  9. 9. The CE Marking Process for Medical Devices Competent Authorities Competent Authorities are entities enforcing Medical Device Directives at the national level in each EU member state. Important: member states and their Competent Authorities each have their own interpretations of how Directives should be carried out. Manufacturers seeking to sell in more than one EU member state should take this into account.ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  10. 10. The CE Marking Process for Medical Devices Notified Bodies Notified Bodies are authorized to audit manufacturers’ quality systems and test /review devices for compliance with applicable EU Directives and standards. Notified Body responsibilities include: •Advising on device classification and Conformity Assessment routes •Pre-assessment of devices •Product and quality system evaluation •Concluding and evaluating manufacturers’ Corrective Actions •Issuance of certifications •Maintaining programmed surveillance of devices in the EUASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  11. 11. The CE Marking Process for Medical Devices Authorized Representative Required for any firm without a location in the EU. Authorized Representatives’ responsibilities may include: •Liaising between manufacturers and Competent Authorities •Listing their names on clients’ device labels and packaging •Notifying Competent Authorities of manufacturers’ and devices’ names •Keeping Technical Files/Design Dossiers available for review by Competent Authorities •Participating in vigilance/post-market surveillance proceduresASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  12. 12. The CE Marking Process for Medical Devices Basic Steps to Compliance in the EU 1. Identify Directives and Regulations appropriate for your device. 2. Classify your device according to MDD Annex IX 3. Implement Quality System in compliance with ISO 13485. 4. Prepare Technical File or Design Dossier demonstrating compliance with MDD 93/42/EEC.ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  13. 13. The CE Marking Process for Medical Devices Steps to Compliance in the EU, cont. 5. Appoint your Authorized Representative. 6. Have Notified Body audit your Quality System and Technical File or Design Dossier 7. Register your device with Competent Authorities if necessary. 8. Prepare Declaration of Conformity and affix CE Marking to your device.ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  14. 14. The CE Marking Process for Medical Devices Step One: Classification/MDD Determination First, determine which Medical Device Directive (MDD, AIMDD or IVDD) applies to your device. Then determine device classification using Annex IX of MDD 93/42/EEC. Class I Non-Sterile Class I Sterile Class I Non-Measuring Class I Measuring Low-risk, non-invasive devices such as non-sterile wound dressings and stethoscopesASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  15. 15. The CE Marking Process for Medical Devices Classification, cont’d. Class IIa Medium-risk, short-term invasive devices such as tracheal tubes and lancetsASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  16. 16. The CE Marking Process for Medical Devices Classification, cont’d. Class IIb Higher-risk, often longer-term surgically invasive, sometimes implantable devices including intra-ocular lenses and surgical lasersASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  17. 17. The CE Marking Process for Medical Devices Classification, cont’d Class III Highest-risk devices, including all active implantable devices such as replacement heart valves and vascular stentsASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  18. 18. The CE Marking Process for Medical Devices Classification Considerations MDD 93/42/EEC Annex IX contains 18 rules for medical device classification based on factors including the following: •Device’s intended use •Active versus non-active functionality •Device’s duration of contact with patient •Degree of invasiveness •Part of body contacted by device •Special situationsASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  19. 19. The CE Marking Process for Medical Devices How Classification is Determined Duration of Contact Criteria Degree of Invasiveness Criteria Less than 60 minutes = Transient Application to body surface versus Less than 30 days = Short-term an orifice More than 30 days = Long-term Surgically invasive or non-invasive Implantable Determining your device’s duration of contact and degree of invasiveness will help determine how to classify the device.ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  20. 20. The CE Marking Process for Medical Devices How Classification is Determined, cont’d. Transient Class I Sterile/Measuring Low-risk Transient Class I Non-sterile/Non-measuring Low-risk Short Term Class IIa Medium-risk Long Term Class IIb Medium-risk Long Term Class III High-riskASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  21. 21. The CE Marking Process for Medical Devices Step Two: Quality System Manufacturers of Class I sterile/measuring, IIa, IIb and III devices must implement quality management systems (QMS) (in compliance with Annex II or V of the MDD). Most manufacturers meet this requirement using ISO 13485.ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  22. 22. The CE Marking Process for Medical Devices Quality System Requirements: ISO 13485 Phase I: Quality system preparation and development •Management buy-in •Assign resources and staff •Conduct gap analysis •Develop quality manual and documentation controlsASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  23. 23. The CE Marking Process for Medical Devices Quality System Requirements, cont’d. Phase II: Implementation • Employee training • Internal auditing • Corrective and preventative actionsASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  24. 24. The CE Marking Process for Medical Devices Quality System Requirements, cont’d. Phase III: Registration • Registration audit performed by Notified Body • Final ISO 13485 certificationASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  25. 25. The CE Marking Process for Medical Devices Step Three: Technical File/Design Dossier Preparation • All Class I, IIa and IIb device manufacturers must prepare Technical Files containing data to demonstrate MDD 93/42/EEC compliance. • Class III device manufacturers must prepare Design Dossiers to demonstrate compliance to MDD. • All manufacturers must have clinical data to demonstrate compliance to MDD.ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  26. 26. The CE Marking Process for Medical Devices Technical File Components A CE Mark Technical File should include the following sections: 1. Description of product family and justification for why your device falls into that family 2. Device intended use 3. Description of device components, specifications, packaging and literature 4. Device manufacturing Process 5. List of accessories to your device 6. Location of design responsibility and manufacturing facilities 7. Classification along with rationale for classificationASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  27. 27. The CE Marking Process for Medical Devices Technical File Components, cont’d. 8. Chosen compliance route according to applicable Directive(s) 9. Declaration of Conformity stating manufacturer’s compliance with applicable Directive(s) 10. Shelf life and environmental limitations of device 11. Retention of quality assurance, Competent Authority and Notified Body records 12. Vigilance reporting and Medical Device Reporting procedures 13. How and when to contact Competent Authorities 14. Name of and contract with your Authorized RepresentativeASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  28. 28. The CE Marking Process for Medical Devices Technical File Components, cont’d. 15. Subcontractor names and addresses if applicable 16. Essential Requirements 17. Design input specifications 18. Application and references to Standards and Guidelines 19. Testing results and clinical evaluations 20. Risk analysis 21. Instructions for Use and LabelingASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  29. 29. The CE Marking Process for Medical Devices Technical File Components: Clinical Data Requirements • EU regulators have increased their requirements for clinical data even for Class I medical devices in recent years. • In many cases, manufacturers must submit Clinical Evaluation Summary Reports that verify the safety and performance of their products along with Technical Files or Design Dossiers.ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  30. 30. The CE Marking Process for Medical Devices Step Four: Authorized Representation Manufacturers with no offices in the EU must appoint Authorized Representatives (EC REPs) to interact with regulators on their behalf.ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  31. 31. The CE Marking Process for Medical Devices EC REP Responsibilities May provide several vital services for foreign manufacturers: •Registering your device with Competent Authorities before commercialization •Serving as primary point of contact with all EU Competent Authorities •Keeping a current copy of your Technical File/Design Dossier available for inspections by Competent Authorities •Authorizing you to place EC REP name and address on your device labels, packaging and instructions for use •Handling Incident and Field Safety Corrective Action (FSCA) reporting to Competent AuthoritiesASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  32. 32. The CE Marking Process for Medical Devices EC REP Responsibilities, cont’d. •Representing you before the European Commission in the event that your product is withdrawn in a member state •Protecting the confidentiality of your product information •Maintaining reports on clinical evaluation data for review by Competent Authorities •Communicating with Competent Authorities on serious device incidents or FSCAsASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  33. 33. The CE Marking Process for Medical Devices Step Five: Notified Body Audit Class I Class IIa Class IIb Class III Sterile/Measuring Following appointment of your EC REP, your quality system and Technical File/Design Dossier must be audited by a Notified Body. Upon Successful completion of your audit, the Notified Body will issue a CE Certificate.ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  34. 34. The CE Marking Process for Medical Devices Notified Body Audit, cont’d. • Manufacturers of Class I Non-sterile/Non-measuring devices self-declare MDD conformity and do not require CE Marking certificates.ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  35. 35. The CE Marking Process for Medical Devices Step Six: Registration with Competent Authorities Class I Non-Sterile/Non-Measuring Class I Sterile/Measuring Class I device manufacturers must register with the Competent Authority of the country where their EC REPs are based.ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  36. 36. The CE Marking Process for Medical Devices Registration with Competent Authorities, cont’d. Class IIa Class IIb Class III Some EU member states do not require registration of Class IIa, IIb or III devices with Competent Authorities. Other countries do not require registration of devices.ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  37. 37. The CE Marking Process for Medical Devices Step Seven: Declaration of Conformity and CE Marking In order to complete the CE Marking process, all manufacturers must prepare a Declaration of Conformity stating their device is in compliance with all applicable Directives. Upon completion of your Declaration of Conformity, you may affix CE Marking to your product.ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  38. 38. The CE Marking Process for Medical Devices Declaration of Conformity, cont’d. Product identification Manufacturer identification EC REP information Applicable DirectivesASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  39. 39. The CE Marking Process for Medical Devices Labeling and Language Requirements EU member states MAY REQUIRE labeling information be made available in their local languages or another European Community language to patients and users in accordance with Annex I, point 13 of the MDD.ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  40. 40. The CE Marking Process for Medical Devices Labeling and Language, cont’d. Language Requirements All languages subject to subsidiarity All EU member states require device labeling in their official languages Label information in your Technical File should only appear in ONE languageASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  41. 41. The CE Marking Process for Medical Devices Post-Market Surveillance (PMS) and Vigilance • PMS required for all medical devices sold in the EU • Manufacturers are required to develop proactive plans for PMS • PMS plans should include reviews of market and field data, complaints and corrective actions • Systematic records of PMS findings must be keptASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  42. 42. The CE Marking Process for Medical Devices Post-Market Surveillance and Vigilance, cont’d. Purpose of Vigilance Requirements •Protecting public health and safety •Evaluating incidents to prevent recurrence •Determining effectiveness of corrective actions taken •Monitoring and learning from experienceASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  43. 43. The CE Marking Process for Medical Devices Post-Market Surveillance and Vigilance, cont’d. Vigilance Requirements for Manufacturers: • Establish and maintain systematic procedures to review experience gained from devices in the post-production phase • Implement appropriate means to apply any necessary corrective actionsASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  44. 44. The CE Marking Process for Medical Devices Additional Resources Want more information Emergo Group services for Europe: or a proposal? http://www.emergogroup.com/services/europe Contact any of our worldwide offices. Regulatory process charts: www.emergorgoup.com/contact http://www.emergogroup.com/literature European medical device regulations: http://www.emergogroup.com/resources/regulations-europe 11-minute video explaining the CE Marking process for medical devices http://www.emergogroup.com/resources/videos-ce-marking Upcoming webinars from Emergo Group: http://www.emergogroup.com/webinars Previously recorded webinars available to view anytime: http://www.emergogroup.com/videosASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com

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