Product approval Europe

A wisely chosen regulatory strategy helps to get the product through "approval" and thus onto the market with minimal costs and as quickly as possible. The Johner Institute is your pilot.

Determination of regulatory strategy

The regulatory strategy provides answers to questions such as:

  • Is my product a medical device? How do I have to formulate the intended purpose in order to achieve or avoid qualification as a medical device?
  • What class does my medical device fall into? How do I have to formulate the intended purpose in order to achieve the desired classification?
  • Is my product a medical device or accessory?
  • Do I have to have the entire product approved as a medical device or can I also put modules on the market as medical devices?
  • Should I make use of the transition periods of the MDR or IVDR? When is it recommended to do so?
  • What should I pay attention to when choosing the Notified Body?
  • Should I set up my own QM system or is it better to use the QM services of a legal manufacturer?
  • How can I save my previous PLM-OEM construct under the MDR or IVDR?
  • Should I start in Europe or the USA first? Can I reuse the documents?

Our regulatory affairs experts work with you to develop the regulatory strategy.

Implementation of the regulatory strategy

The Johner Institute helps you to implement your regulatory strategy:

  • Classify your product
  • Formulate the intended purpose
  • Select a notified body
  • Compile a list of the required documents
  • Create these documents (e.g. technical documentation)
  • Communicate with notified bodies
  • Select lawyers in case of disputes
  • Review documents before submitting them
  • Manage the project

Get in touch

If you also have one of the above questions or if you would like support with the approval of your medical device, please contact us right away.

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