About the author: I created this website to help startups and small businesses understand the medical device regulation, in the hope that some might successfully bring new life improving products to European patients. As a medical device regulatory affairs and quality management professional, retired after a 35-year career with a major German pharmaceutical company, I have experience of CE marking hundreds of medical devices and diagnostics.
Inventors or startups in the health, wellness and lifestyle space: Do you have a question? Still wondering if your innovative product idea is likely to fall under the scope of the medical device regulations? Or, how best to address regulatory compliance during your product’s development. Ask your question using the contact form below.
Micro and small enterprises: Do you have a question? Still unsure how you can fulfil the manufacturers obligations? Or, what to expect when dealing with a notified body. Ask your question using the contact form below.
Importers and distributors: Please read the questions and answers posted in the comments section of the dedicated page. Most common questions have already been asked and answered and posting your questions there may benefit other visitors too. Thank you.
Privacy notice: Your personal data (ie. name, email address) will be stored, for the purpose of responding to your communication, but it will not be shared with others. You can request the details of your personal data, or its deletion, at any time using the contact form.