Demystify Series : Getting CE Mark for Medical Devices from India

5. How to select the right Notifying Body (NB)?

Unlike USFDA, CE Marking is not a single organisation procedure. Third parties or notifying bodies such as TUV, DNV, BSI and many more are authorised to conduct audits and determine the preparedness to grant the CE mark. You can find a list of approved notifying bodies here. However selection of the right NB is easier said than done.

• Firstly, you need to make a list of Notified Bodies based on the product codes they are authorised to conduct audits on. Then, see how many of them are qualified to conduct an audit on your medical device.

• Secondly, request for a meeting/call to discuss the device with each one of them.

• Thirdly, get a quote and compare from each Notified Bodies qualified for your type of medical device.

• Then, select the notified body based on their:

  • Past experience in auditing and approving similar devices

  • Their location- Ask if they have auditors based out of India to conduct an audit. If auditors need to come from Europe, cost can significantly rise.

  • Check their reputation in the market- Easiest way is to ask your Distributors/Customers.

  • Budget- This can also be negotiated based on how many man days they need to allocate for the audit.

I have seen companies getting expensive Tier 1 Notified Body for a Class I- low risk device. While it may be a safe bet, do ensure it does not end up emptying your bank accounts. At the end of the day all CE Mark approvals give the same access to the market. While there used to be notified bodies with bad reputation, that is no more the case in Europe especially with MDR (Medical Device Regulations) coming in force by April 2021.

6. How did Axio go about the process of getting CE approval for MaxioCel?

The whole process started around 8 months back when COVID-19 pandemic was in rage. As we already had approval in India for MaxioCel, many of the documentation such as Design files (DHF etc), Tech files were already in place. We also had real time stability data, PMS (Post marketing surveillance) data, Preclinical animal study data, and Human studies data collection was ongoing. Our manufacturing facility already has Quality Management System (QMS) compliance with ISO 13485:2016 and is being audited regularly by our notified body. These helped us in getting the submission process in order soon.

 

Axio Biosolutions Pvt. Ltd. Axio is a deep-science medical technology company with extensive expertise in biomaterials based medical devices for pre-hospital, intra-operative and post-operative clinical needs. Our focus is on devices for management of trauma, surgical and chronic wounds. We bring together our biomaterials expertise with the contemporary knowledge of medicine and engineering to design novel solutions for management of trauma, surgical and chronic-infectious wounds. Our flagship product, Axiostat, is a patented, clinically validated haemostat that stops moderate to severe bleeding instantly in surgeries and in pre-hospital trauma. Axiostat is USFDA 510(k) cleared and is also European CE approved. In Advanced Wound Care range, Axio has launched the nextgeneration MaxioCel wound dressing. MaxioCel is designed to heal patients suffering from acute and chronic wounds (diabetic foot ulcers,

pressure ulcers, burns, bed sores, cavity wounds and surgical site infections) by effectively managing exudates, pain reduction and scar less healing. Axio has recently expanded its portfolio to include RESIST+ range of high-quality hygiene and protection solutions. RESIST+ range includes alcohol-based sanitizers, surface disinfectants, disinfecting wipes, and antimicrobial hand wash, manufactured under without any toxic chemicals. All Axio products are manufactured in state-of-the-art ISO 13485 and GMP certified facility. Axio intends to be the first choice for any customer looking for advanced wound care, hemostatic, and hygiene solutions worldwide and the company is positioned to upgrade wound care and hygiene care in both the institutional and consumer segments.

As we do for any such approval process, we soon created a core interdisciplinary group with our in-house Regulatory team headed by Ramya, Quality team by Saurabh and R&D team by Dr Kiran. They along with other team members actively started daily scrum meetings and collaborated on Google Docs in real-time. We had to build a complete CER (Clinical Evaluation Report) document which needed help from our in-house clinical research team. Also the most important document which is Risk Management had to be made. Each of these ran into 600+ pages and went through multiple iterations by our team. Remaining Biocompatibility and Animal studies were also completed during this period.

We also occasionally checked-in with our external consultant team and also with the notified body team to ensure we are all on the same page with respect to timeline and document preparedness.

After few months we got the audit dates from Notified Body. They did many man-day audits with 4 of their auditors. Thanks to a thorough preparation, our audits went without any Non Conformity. This was a pleasant surprise as we usually do not see an audit without any NC. Final review was conducted at European office of the notified body and we got the clearance last week.

7. Is the CE approval really worth it?

This answer could vary based on your specific go-to-market strategies. If you are a 100% India market focused company, then CE mark may be unnecessary. However going through the CE Marking process is a great way to bring discipline and to implement a proper Quality Management System in your organisation. It also guides the entire team to the goal of developing and shipping products that comply to global standards.

If you are looking at expanding into global markets, I strongly recommend you to consider getting a CE mark for your medical device. It brings a lot of credibility in he global market and also gives you a single window access to one of the largest lucrative medical device markets in the world.

8. As a founder should I prioritise CE Mark over fundraising?

This is a common question I get from many medtech founders. While there is no right or wrong answer for this, my recommendation is to not invest in getting CE Mark atleast until you have raised a seed round of a crore or above. Be prepared for it and get your design files in place, ensure you have a roadmap towards the submission process. Walk the potential investors through the process and ensure they understand the timelines for your global GTM clearly.

Finally this wouldn't have been possible without a team who is passionate about building quality global products. A big shoutout to all Axions who helped us attain this.

Hope this article is helpful. Feel free to reach out to us for any clarifications and our team will be happy to share our learnings.