Europe IVD approval chart - Emergo Group

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Easy to understand chart describes the IVD regulatory process for the European Union.

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Europe IVD approval chart - Emergo Group

  1. 1. The regulatory process for In Vitro Devices (IVDs) EUEurope * Self-testing IVDs exclude devices that are included in Annex II, List A and List B. This is a simplified overview of the process. Your Notified Body may choose to audit your submission and request more documents, which will add time to your approval. © 2014 Emergo – You are welcome to publish this chart on your website, or copy it for use in presentations or other materials if it is not cropped in any way. Have comments or suggestions about the content of this chart? Email us at marketing@emergogroup.com. Chart updated 09/2014. 5175-0914 EmergoGroup.com/europe Determine the classification of your IVD in accordance with the In Vitro Diagnostic Medical Devices Directive (98/79/EC). General IVD Self-certified Self-Testing IVD* List B IVD (Annex II) List A IVD (Annex II) Implement Quality Management System (QMS) in accordance with Annex IV or VII of 98/79/EC. Most companies apply the ISO 13485 standard to achieve QMS compliance. Prepare a Technical File (Design Dossier for List A IVD) which provides detailed information demonstrating compliance with 98/79/EC. Appoint an Authorized Representative (EC REP) located in Europe and qualified to handle regulatory issues. Place EC REP name and address on Instructions for Use or outer packaging or device label wherever sold in Europe. Your QMS and Technical File must be audited by a European Notified Body, a third party accredited by the European authorities to audit medical device companies and products. CE Marking certificate for your device will be issued upon successful completion of the Notified Body audit. Your IVD(s) must be registered with the European Competent Authority (Ministry of Health) where your Authorized Representative is based. Additional notifications to other countries may be required. Prepare a Declaration of Conformity, a legally binding document prepared by the manufacturer stating that your IVD is in compliance with the applicable Directive. You may now affix CE Marking to your IVD. The self-certified CE Marking certificate does not expire as long as you remain in compliance with 98/79/EC. You will be audited by a Notified Body every 6-12 months to ensure ongoing compliance with the applicable Annex of 98/79/EC. Failure to pass the audit will invalidate your CE Marking certificate. Conduct ongoing batch testing and forward results to your Notified Body. IVD LOT
  2. 2. The regulatory process for In Vitro Devices (IVDs) NOTE 1: The time frames shown above are typical for the majority of medical device submissions but assume that your device does not contain animal tissue, medicinal substances or employ entirely novel technology. Your length of approval will depend on the quality and completeness of your technical documentation and how much time you take to address additional information requests from authorities after submission. YOUR SUBMISSION(S) MAY TAKE MORE TIME THAN WHAT IS SHOWN ABOVE. NOTE 2: Registrations remain valid for the time specified as long as you do not make changes to the device, intended use or indications for use. NOTE 3: We recommend starting the re-registration process no later than the time period specified above. However, please consult with your distributor or regulatory expert well before this suggested time to avoid any lapse in your registration. NOTE 4: Our rating of the complexity of the registration process is based on our experience and the opinion of nearly 1,000 QA/RA professionals worldwide who were asked to rate the difficulty of registering a device in each country in January 2014. The European CE Marking process is considered the mid-point to which all other markets are compared. NOTE 5: Low = Less than US$5000; Midpoint = US$15000-$30000: High = More than US$50000. Overall cost includes registration application fees, product testing, in-country representation, submission preparation consulting and translation of registration documents but not IFU. Costs assume you already have approval for your device in the United States, Europe, Canada or Japan. Does not include cost of implementing, auditing, or updating a quality management system compliant with ISO 13485 or US FDA 21 CFR Part 820, if applicable. * Self-testing IVDs exclude devices that are included in Annex II, List A and List B. © 2014 Emergo – You are welcome to publish this chart on your website, or copy it for use in presentations or other materials if it is not cropped in any way. Have comments or suggestions about the content of this chart? Email us at marketing@emergogroup.com. Chart updated 09/2014. EmergoGroup.com/europe EUEurope IVD classification in Europe How long you should expect to wait after submission until approval is granted. (See note 1) Validity period for CE Marking certificate. (See note 2) Registration renewal should be started this far in advance. (See note 3) Complexity of the registration process for this classification. (See note 4) Overall cost of gaining regulatory approval. (See note 5) General IVD Self-certified <1 month Does not expire Not applicable Simple Complex Low High Self-Testing IVD* 3-5 months 3 years 2 months Simple Complex Low High List B IVD (Annex II) 3-5 months 3 years 2 months Simple Complex Low High List A IVD (Annex II) 9-12 months 3 years 2 months Simple Complex Low High

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