Product approval Europe

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