Navigating the complex regulatory landscape as a medical device manufacturer is pretty difficult. Especially when you have to deal with tons of complex jargon, laws from god knows where, and experts like the notified body coming to your door and demanding an explanation for why your device looks the way it does!
Jokes aside, notified bodies are pretty scary. However, we think it’s mostly because people don’t really know much about them as much as they hear stories about them. Sure, we have all heard about the horror stories of not getting CER marks due to notified body audit disasters.
But have we really thought about why exactly those audits failed? Trust me, notified bodies aren’t out there to get you. It’s just their job to make sure the medical devices get made as perfectly as possible. It’s your job to convince them. We will learn how in this article. Let’s start with a few basics.
What is a Notified Body, and what do they do?
Each EU member state has a list of Notified Bodies that you can choose from. Their job is to evaluate a product’s (medical device) conformance to the Medical Device Regulation before it is sold to the public. Notified Bodies are essential for a product’s approval and commercial success since they are the connecting link between the product and the European Union market.
On behalf of the appropriate authorities in the EU Member States, a Notified Body performs conformity assessments according to the procedures and timeframes outlined in the applicable legislation. You can sell your products in the European Union with their help once they have given you the CE mark, which means you are compliant to the EU MDR.
What is the auditing procedure like?
As you can imagine, audits conducted by the Notified Body are pretty rigorous. Since whether you will be getting a CE mark depends largely on these audits and the notified body approval, they can cause a great deal of anxiety as well. There are two main types of evaluations: the first one that leads to CE marking and the annual one that checks for continuous conformity. The Notified Bodies audit’s scope has to be obtained before you can even begin to prepare for them. Technical, quality, and clinical documentation, as well as your Quality Management System and MDR compliance as a whole, will be audited independently. They will try to find any inconsistencies and suggest immediate measures to fix them throughout this evaluation. The Notified Body will grant CE marking only once all of these requirements have been met.
What are the many categories of Notified Bodies?
Under the MDR, around 30 Notified Bodies are authorized to undertake conformity assessments and are active right now. Depending on the type of medical equipment, the duration of the audit, and their experience, the fees of the Notified Body you choose can vary. Whichever you choose, ensure they are accredited and have relevant product knowledge. For example, if you are creating a Class I device or any in vitro diagnostic medical devices, selecting a Notified Body with competence in Class II or III devices would be inappropriate.
What exactly does a notified body do?
So, in short, all Medical devices sold in European Union (EU) countries must pass designated notified bodies’ quality assurance and conformity assessment procedure. Their job is to undertake assessments to guarantee that a product is risk-free, efficient, and accurately labeled before it hits store shelves. They actually work in many other regulations of the EU as well. The MDR is just one example of a Directive or Regulation for which Notified Bodies provide certifications of compliance. In addition, they undertake surprise audits to ensure ongoing compliance and offer guidance on interpreting rules and regulations.
What happens during a notified body audit?
The Notified Body will inspect your product and manufacturing procedure thoroughly. All aspects of the Quality Management System (QMS), including relevant standards, labeling mandates, and risk management documents, must be thoroughly reviewed to ensure regulatory compliance. During the on-site audit, the Notified Body may also conduct interviews with employees and witness testing or production processes.
What should I look for when choosing a Notified Body?
When choosing a Notified Body, keep the following factors in mind:
- Ensure that it has been accredited and authorized by the applicable Competent Authority.
- Examine their knowledge of your product’s classification and risk level.
- Check to see if their evaluation method is well-structured and efficient.
- Ensure they meet all requirements for conflict of interest, confidentiality, honesty, resource adequacy, and ability.
- Check to see if they are dedicated to giving excellent customer service.
- Confirm whether they have appropriate expertise working with regulatory agencies.
- Determine how responsive they are in responding to any concerns or issues.
- Determine whether their services include post-market surveillance operations such as field safety corrective measures and recall.
How long does it take to obtain a certificate from a Notified Body?
The time it takes to get a certificate of compliance from a Notified Body varies depending on the complexity of the product, the type of assessment required, and the quality system the manufacturer uses. In general, shorter tests can be completed in 6-12 months, whereas more sophisticated reviews can take up to 18-24 months. They do have an extension in place for the MDR conformity, but most medical device manufacturers will not take any risk and book their notified body as soon as possible.
How can you make the auditing and CER approval processes easier?
Preparation is essential for making the process easier and should begin well before the application deadline. Here are some pointers to think about:
- Engage with the Notified Body early on to understand their expectations.
- Prepare and review your technical documentation with a third party to guarantee MDR compliance.
- Create a robust Quality Management System and put it in place well before the audit.
- Ensure your clinical data is appropriately organized, acquired using the appropriate technique, and accurately documented.
- Work with a professional regulatory affairs specialist who can guide you through the MDR application procedure.
Audits and getting approved are daunting. We get it. But, you will find it much easier to go through when you have an excellent grasp of what Notified Bodyworks and the audit process are. Preparing ahead of time, implementing a Quality Management System, and working with a qualified regulatory affairs consultant can all help to make the audit more bearable. Remember that the Notified Body is there to assist you in ensuring that your product is compatible and safe for the EU market. They really want to approve your device, all you have to do is help them do that!