How to increase chances of a successful application with a notified body

by | Feb 2, 2022 | MDR

MHRA Guidance

 

The Best Ways to engage with your Notified Body

The strain on Notified Bodies during the current climate is monumental. This is having a direct effect on manufacturers being able to sell medical devices, due to fewer notified bodies being designated to the applicable regulations.  concern is growing  throughout the medical device industry, resulting in increasing pressure when co-ordinating an application with a Notified Body. Having joined IMed from a Notified Body myself, I’d like to offer a few tips to improve your chances of being successful with your application:

 

  • Approach a Notified Body well in advance! Lead times can be up to 1 year for even a 1-day stage 1 ISO 13485 audit, so it is important to have this conversation early and be presented with realistic timelines. Some Notified Bodies offer initial meetings with members of their sales and technical teams. This can be a great way to ask any of your early queries on the process/timelines/capacity of the technical team to ensure you are able to make the best decisions for your business.

 

  • Be honest with where your company is at within the CE/ISO 13485 timeline. If you are a start-up company, just beginning to write your quality policy or design procedures, the Notified Body needs to be made aware. This is because a minimum of 3 months’ worth of evidence is recommended for review at the time of your stage 1 audit.. Notified Bodies can book your audit up to a year and a half in advance, so once you have your foot in the door, you’ll have a visible deadline to work towards.

 

  • When asked for information during the initial quoting process, try to make sure all information is presented accurately and in full, from the start. Precious time can be wasted going between parties, when information is incorrect or missing. To provide a quotation for an audit/technical file review, the Notified ody will ask for details such as: number of sites, employee count for each site, , what services are conducted at each site etc. Although this information may seem unnecessary for an initial review, it is required to calculate audit duration and subsequent- cost. If you are a multi-site organisation and one site is used only for storage/distribution, let them know this early! Some Notified Bodies offer a 50% reduction (in the audit days calculation, rather than the price) for storage/distribution only sites, as these activities require less time for the auditor to review.

 

  • Due to high demand, some Notified Bodies s are only taking on new CE marking work for existing clients. This is discouraging and can put manufacturers who are not existing clients in a difficult position. One potential way to combat this potential obstacle is to approach a Notified Body first, for an ISO 13485 certificate (if your QMS is ready for an audit). This can get you into the Notified Body’s internal ‘queue’ earlier than if you were to wait for your CE mark’s technical documentation to be compiled and ready. You can then continue to develop the necessary technical documents in the background, whilst awaiting your ISO 13485 certificate, which means that you will be considered an ‘existing client’ by the time your CE Marking documentation is ready for you to apply with. The Notified Body should also then be able to co-ordinate your audits, so that they are done together once a year saving you time and money for years to come!

 

IMED can help you with your approach to and engagement with your Notified Body. Just get in touch to get our initial guidance and ongoing support by calling us on 01295 724286  or via email to alison@imedconsultancy.com

Cindy Rajaratnam

Cindy Rajaratnam

Regulatory Associate

Click here to learn more about our Clinical Writing Services: