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VDE
2023-03-02 expert contribution

Approval and market access for medical devices and software

VDE offers practical advice and training for approval and market access of medical devices and software. Get your medical device to the EU market safely and quickly. 

Contact
Dipl.-Ing. Hans Wenner

Are you developing hardware or software for medical or health-related purposes and want to bring it to market? Then you are confronted with a multitude of laws, regulations, directives and standards, because before you can put your product on the market, you have to prove that it is safe and fulfills its purpose. This is where we can help you with our many years of experience. Together with you, we bring your new product onto the regulated market safely, quickly and with as little effort as possible. 

Placing medical devices and medical software on the market   

We advise and support you in all questions concerning the approval and certification of medical devices. 

Our focus is on active medical devices including medical software. In detail we advise you on: 

  • Approach and effort planning 
  • Formulation of the intended purpose 
  • Qualification as a medical device 
  • Risk classification of the product 
  • Analysis of all relevant laws, standards and other documents 
  • Implementation of the quality management system 
  • Implementation of the risk management system 
  • Implementation of the clinical evaluation 
  • Implementation of post-market surveillance (PMS) 
  • Fulfillment of the Essential Safety and Performance Requirements 
  • Preparation and updating of technical documentation 
  • Implementation of the required registrations 
  • Preparation of instructions for use and labeling 
  • Selection of and cooperation with a Notified Body 
  • Declaration of conformity and CE marking 

If you first need a dedicated requirements and process plan for your medical device, combined with an estimate of the costs and duration of the approval of your medical device, we recommend our "CE Roadmap for Medical Devices".   

Many problems can be avoided at an early stage if regulatory requirements are taken into account right from the start and undesirable developments are avoided. At this point, the CE roadmap provides essential information and also helps to correctly assess the economic risks of the project. 

Smaller, young or industry-new technology companies also face particular challenges when it comes to medical device approval. Often, the projects are financed by external donors. Here, the CE roadmap helps to make correct assumptions when presenting the financing and to create confidence among the funders. Often, the effort required for approval is significantly underestimated. 

In the case of medical software, we are particularly concerned with the aspects of cybersecurity and artificial intelligence. In both cases, there are specific requirements for approval. 

On the one hand, we have developed a special cybersecurity risk management system for medical devices, because mandatory risk management must also address risks arising from cyber threats. This is exactly where we offer help with our ARGOS process: 

  • MDR-compliant processes for integrating cybersecurity management into risk management, 
  • MDR-compliant processes for post-market cybersecurity risk management, and 
  • tailored processes, with the goal of implementing only those cyber risk mitigation measures that are actually required. 

Second, we have developed an approach for efficient market access for artificial intelligence (AI)-based software. AI medical devices are characterized by the AI model and training data in addition to the software code. This raises specific issues, e.g., generalizability, transparency, and representativeness. With our BAIM process, we offer manufacturers support in bringing AI medical devices to market in a compliant manner: 

  • Product-specific analysis of all regulatory AI requirements. 
  • AI-adapted implementation of the quality management system 
  • AI-adapted extension of software lifecycle processes 

To provide you with the necessary regulatory know-how, we also offer to tailor in-house workshops specifically for your company. In addition, you can find our ongoing training and event offerings here. 

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