Learn how to safely pass the medical device approval process

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Overview
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Prof. Dr. Christian Johner
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Quality Managers, Developers, Usability Engineers, Regulatory Affairs Managers, Risk Managers, Project Managers
Foundation
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veröffentlicht am 14.09.17
As the name already points out, is this training a very brief introduction to the European Medical Device Law. It goes to a very compact on the basic requirements, the role of harmonized standards and notified bodies and the conformity assessment process.
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 Start

Do you have a medical device? A device you’d like to sell in the European Community? Then you have to stick to the European medical device regulations. This short video training provides you an overview on the necessary steps.

Any medical device sold in an European country must bear a CE label. With this label you express that your product meets the legal requirements, in particular the so-called “essential requirements” as described in European directives. You have to accomplish two things:

     

  • First you are obliged to develop and produce your medical device compliant with these requirements.
  • Second you have to prove that you actually did so.
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So let’s discuss what the essential requirements are and how you can prove compliance.

Essential Requirements

There are three European medical device regulations, the medical device directives. The most important one actually is called “Medical Device Directive”, in short MDD. It clearly states the essential requirements. Focusing on software these requirements include:

     

  • Risk management,
  • Usability Engineering and
  • Software life cycle processes.
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The medical device directive also provides us with a mean to prove evidence that our product is compliant with these requirements: The harmonized standards. In other word: If you comply with the harmonized standards one has to assume that your product is compliant with the essential requirements.

For each of these requirements there is a corresponding harmonized standard:

     

  • ISO 14971 helps you proving compliance with risk management,
  • IEC 62304 helps you proving compliance with software processes and
  • IEC 62366 helps you proving compliance with the legal requirements related to usability.
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To avoid any misunderstanding: Being not compliant with a standard does not automatically mean that you are not compliant with the law. You just lost your mean to prove.

Please watch our other trainings to learn more about the harmonized standards, about risk management, software life cycle and usability engineering.

Technical File

Whether your products comply with the standards and thereby with the essential requirements an auditor or – worst case a judge – will decide based on your documentation. What is not documented does not exist. This is their simple mindset. I.e. you have to compile this documentation; also referred to as the “technical file”.

Important parts of this technical file are the risk management file, the usability file and the software life cycle documentation. Dependent on the type of your product the technical file also has to address electrical safety, mechanical safety, sterilization or otherConformity assessment

Having compiled this technical file you have different alternatives of assessing the conformity of your product. These different routes are called the “conformity assessment procedures”. Dependent on the class of your device, this technical file might be all you need. Or you additionally have to submit this file to a notified body first. Notified bodies are accredited companies as the TÜVs, MedCert, VDE or BSI.

There are four different classes. Class I are the non critical devices as glasses. Class IIa devices might cause harm to patients, IIb devices even might cause severe harm, and III is the highest class. We have prepared a dedicated video training on the classification of medical devices.

In particular for medical products with a higher class and in a way for products that contain software or are software themselves additionally a quality management system is required. Also for quality management systems there is a harmonized standard, ISO 13485.

Especially for software we recommend the following procedure:

     

  • Establish a quality management system that ideally is compliant with ISO 13485.
  • As part of that define your processes in particular the software development, the risk management and the usability engineering process. These process definitions have to comply with the respective standards as well.
  • Develop your device according to your processes and document what you are doing. As output you have your device and the technical file.
  • Dependent on the class of your device submit the technical file to a notified body and
  • declare the conformity. You declare it! You declare it by affixing the CE label to your device and writing a “declaration of conformity”. That’s it.
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We have prepared a comprehensive set of video trainings on the legal system, on the harmonized standards, the conformity assessment procedures, on quality management systems, software life cycle processes, risk management, on writing the technical file, preparing audits and much more.

However, we hope that already this first training could give you a first overview: MDD in a nutshell so to say.

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A safe bet - not just in audits

The E-Learning Library will help you 

  • minimize embarrassing difficulties in the audit,
  • avoid wasting time and money on rectification (a re-audit will cost about 1,000 EUR, in addition to internal resources)
  • accelerate the process to the market for your product because you will avoid unnecessary project delays, e.g due to unnecessary rectification or elaborative (retrospective) development of your technical documentation. You would be surprised to know how much a project delay would cost you, try to divide your product revenue in a year into twelve, then you can see how much it already affects your monthly cost.
  • avoid expensive consultants and save your budget up to five-figures sum.

Your investment

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