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October 2013
Certification and
registration
Medical devices on the
European market
Certification and registration 	 Medical devices on the European market 3
Certification and
registration
Certification and...
Certification and registration 	 Medical devices on the European market4 ttopstart
This publication provides an overview o...
Certification and registration 	 Medical devices on the European market 5
Contents
Scope	
European legislation on medical ...
Certification and registration 	 Medical devices on the European market6 ttopstart
Scope
Modern medicine strongly depends ...
Certification and registration 	 Medical devices on the European market 7
In Europe, registration of medical devices is su...
www.ttopstart.nl
Read complete
document
You can download the complete document for free at our website, follow or
copy and...
Certification and registration 	 Medical devices on the European market22 ttopstart
About ttopstart
ttopstart is a science...
Certification and registration 	 Medical devices on the European market 23
Copyright © 2013 ttopstart B.V.
This report is ...
Certification and registration Medical devices on the European market - ttopstart spottlight
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Certification and registration Medical devices on the European market - ttopstart spottlight

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This publication provides an overview of the regulations and legislations with regard to commercialisation of medical devices. The product category of medical devices includes in vitro diagnostics (IVDs), active implantable medical devices (AIMDs) as well as medical software. In Europe, market approval for medical devices is achieved via a decentralised procedure of CE marking, whereby quality and safety is addressed, and registration of the product. This procedure is in compliance with European regulations and with national legislation of the countries in which market entry is planned. In the US, market approval is granted by the FDA upon assessment of quality, safety and effectiveness. Though complex, the decentralised European system seems to speed up the access to medical devices at least three years as compared to the central system in the US or systems elsewhere in the world.

The information provided here informs start-ups, spin-offs and biotech companies about the differences in regulative procedures for specific classes of medical devices and between the authorities and regulations in Europe and the US. By summarising the build-up of a technical file, the significance of a quality management system (QMS), the selection of Annexes, the advantages of adherence to ISO standards, the use of MEDDEV guidelines and the procedures for standalone software and IVDs specifically, we aim to offer a guide through dense regulative and legislative landscape. These insights can be used to design the optimal market introduction strategy for your medical device.

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Certification and registration Medical devices on the European market - ttopstart spottlight

  1. 1. October 2013 Certification and registration Medical devices on the European market
  2. 2. Certification and registration Medical devices on the European market 3 Certification and registration Certification and registration Medical devices on the European market
  3. 3. Certification and registration Medical devices on the European market4 ttopstart This publication provides an overview of the regulations and legislations with regard to commercialisation of medical devices. The product category of medical devices includes in vitro diagnostics (IVDs), active implantable medi- cal devices (AIMDs) as well as medical software. In Europe, market approval for medical devices is achieved via a decentralised procedure of CE marking, whereby quality and safety is addressed, and registration of the product. This procedure is in compliance with European regulations and with national legislation of the countries in which market entry is planned. In the US, market approval is granted by the FDA upon assessment of quality, safety and effectiveness. Though complex, the decentralised European system seems to speed up the access to medical devices at least three years as compared to the central system in the US or systems elsewhere in the world. The information provided here informs start-ups, spin-offs and biotech companies about the differences in regulative procedures for specific classes of medical devices and between the authorities and regulations in Europe and the US. By summarising the build-up of a technical file, the significance of a quality management system (QMS), the selection of Annexes, the advan- tages of adherence to ISO standards, the use of MEDDEV guidelines and the procedures for standalone software and IVDs specifically, we aim to offer a guide through dense regulative and legislative landscape. These insights can be used to design the optimal market introduction strategy for your medical device. Executive summary
  4. 4. Certification and registration Medical devices on the European market 5 Contents Scope European legislation on medical devices Medical devices Medical software In vitro diagnostic medical devices Active implantable medical devices CE certification Notified Bodies Preliminary procedure CE certification procedure QMS Technical file Investment Follow-up and extension Registration Eudamed NOTIS Registration and market approval in Europe versus US Importing US products into Europe Exporting EU products into the US Conclusion Appendix I Appendix II Appendix III 6 7 9 10 10 11 12 12 12 13 13 14 15 15 16 16 16 17 17 17 18 19 20 21
  5. 5. Certification and registration Medical devices on the European market6 ttopstart Scope Modern medicine strongly depends on the use of medical devices for purpos- es of both care and cure. In contrast to pharmaceutical products, their primary mode of action is not pharmacological, immunological or metabolic. Medical devices range from large capital hospital fixed equipment, through high- technology implants, surgical and monitoring equipment, to more familiar products such as wheelchairs, sticking plasters, syringes, incontinence aids and spectacles. The product category of medical devices falls apart in three classes: medical devices (making up about 80% of the total including medical software), in vitro diagnostics (IVDs) and active implantable medical devices (AIMDs). Examples of IVD devices include reactors, instruments or other devices used for examining sample material from the human body, including excreted material, for providing information to ensure a correct patient diag- nosis. An AIMD is any medical device which is totally or partially introduced (surgically or medically) into the human body and which is intended to remain after the procedure. Common examples are pacemakers, defibrillators, coch- lear implants, insulin pumps and neurostimulators. Market introduction of medical devices is preceded by certification and reg- istration, which are accomplished in compliance with national and interna- tional regulations. Certification by placing the CE-mark is a requirement for selling most medical products and equipment in the EU. For certification, each country has appointed one or more authorities to perform the certification procedure. In Europe, these authorities are named notified bodies (NBs) and operate independently of each other. The objective of NBs is to assess the performance of medical devices in terms of performance and safety, while evidence of effectiveness is not required at the stage of certification.
  6. 6. Certification and registration Medical devices on the European market 7 In Europe, registration of medical devices is subject to harmonised European directives established in the 1990s. The core legal framework consists of three directives: Directive 90/385/EEC regarding active implantable medical devices (AIMDD 90/385/EC), Directive 93/42/EEC regarding medical devices (MDD 93/42/EC) and the Directive 98/79/EC regarding in vitro diagnostic medical devices (IVDD 98/79/EC). The directives aim at ensuring a high level of protection of human health and safety and proper functioning. The directives define safety and performance requirements for medical devices sold in the EU and apply to both products and manufacturers. They have been supplemented over time by several modi- fying and implementing directives. European legislation on medical devices EU Directive Device category Class/list NB involvement Dutch registration European registration MDD 93/42/EC Medical device class I X NOTIS system (CIBG/Farmatec) Eudamed class Is √ to assess “sterile” or “measure” aspect IGZ via NB class Im class IIa √ IGZ via NBclass IIb class III IVDD 98/79/EC High-risk IVD list A √ IGZ via NBlist B self-tests Low-risk IVD other X NOTIS system (CIBG/Farmatec) AIMDD 90/385/EC AIMD n/a √ IGZ via NB Table 1 – Overview of medical devices directives, categories, classes and lists
  7. 7. www.ttopstart.nl Read complete document You can download the complete document for free at our website, follow or copy and paste the following link to find the document. http://www.ttopstart.com/news/spottlight-report-certification-and- registration-of-medical-devices-on-the
  8. 8. Certification and registration Medical devices on the European market22 ttopstart About ttopstart ttopstart is a science and business consulting company that serves leading research- ers and innovative companies in the fields of life sciences and medical technology. We acquire funding for cutting-edge research and development, co-create corporate strategies and conduct detailed market assessments. Our driver is the contribution to development of innovations that can strongly advance healthcare, such as diagnostics and treatments for a wide range of diseases with unmet medical needs. If you need more information or require advice on the regulative aspects of commercial- isation of a (active implantable) medical device, in vitro diagnostic or medical software, please contact us: Contact and information Contact us info@ttopstart.com
  9. 9. Certification and registration Medical devices on the European market 23 Copyright © 2013 ttopstart B.V. This report is published by ttopstart B.V. All rights reserved. Reproduction or redistribution of this report in any form for any purpose is expressly prohibited without the prior consent of ttopstart B.V. ttopstart B.V. accepts no liability for the accuracy or completeness of the information, advice or comment contained in this report nor for any actions taken in reliance thereon. While information, advice or comment is believed to be correct at the time of publication, no responsibility can be accepted by ttopstart B.V. for its completeness or accuracy.

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