Demystify Series : Getting CE Mark for Medical Devices from India

I will try to make this as short as possible and will break it into a few sections for quick and easy reference.

Highlights

1. Why do you need CE Marking ?
2. How expensive it is to get CE Markin ?
3. Whats the process of getting CE Marking for a medical device ?
4. Do we need an external agency or
a consultant to get CE marking ?
5. How to select the right Notifying Body (NB) ?
6. How did Axio go about the process of getting CE approval for MaxioCel ?
7. Is CE approval really worth it ?
8. As a Founder should I prioritise CE Mark over Fund raising ?

1. Why do you need CE Marking?

Short answer is, you get to sell in more countries globally, thereby increasing your footprint exponentially and also it helps in building credibility within the doctor's community in India. Every country follows their own regulatory system, for eg: USFDA is for selling in the US. CE Mark is mandatory to sell medical devices within any of the 32 European Union countries. It also validates that your device complies with all regulations put forward by European Union, which is accepted by many other countries too. However CE mark is accepted by many countries and hence investment can be justified easily.

2. How expensive is it to get CE Marking?

This could very well vary depending on the type and risk classification of your medical device. However a fair estimation could be anywhere from 10lacs to 30lacs for Class I, Class II devices and 30lacs-1crore+ for Class III devices. Based on development costs, pre-clinical studies and clinical studies (with new MDR regulations this could be mandatory), cost can even go into few crores, especially if it is an implantable device.

3. What's the process of getting CE Marking for a medical device?

Emergo has laid out an easy to understand stepwise process:

• Determine which EU Directive applies to your device: Medical Devices Directive (93/42/EEC), In Vitro Diagnostic Devices Directive (98/79/EC), or Active Implantable Medical Devices Directive (90/385/EEC).

• Determine the classification of your device.

• Implement a Quality Management System, if applicable to your device. Most companies use ISO 13485 to meet the requirements.

• Prepare a CE Marking Technical File or a Design Dossier.

• Prepare a Clinical Evaluation Report (CER) according to MEDDEV 2.7/1 rev4 and MDD (or MDR).

• Select and appoint a European Authorized Representative to act on your behalf within the EU if you have no physical location in Europe.

• Have your QMS and Technical File/Design Dossier audited by a Notified Body, unless your device is Class I, is not sterile, and has no measuring function.

• Obtain CE Marking and ISO 13485 certificates from your Notified Body.

• Prepare a Declaration of Conformity (DoC), which states that your device complies with the appropriate Directive.

4. Do we need an external agency or a consultant to get CE marking?

In my experience, a lot of pitfalls in documentation can be avoided early on if you have someone experienced to guide you. As the CE marking process is largely audited by reviewing documentation, every mistake can prolong the audit review and thereby adding $$$ to your bills. I have seen minor mistakes in the “Declaration of Conformity” being granted a Major Observation “Non Conformity” during audits.

Hence, while it is not a mandatory requirement, I recommend to start the process of your first medical device with either having someone experienced in your team and/or an external consultant who could guide you.