How To Choose The Right Notified Body 

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Most medical device companies must undergo a conformity assessment (essentially an audit) prescribed by a Notified Body in order to receive a CE marking. This process is required for all medical devices and in vitro diagnostic (IVD) devices except the lowest-risk devices (Class I and Class A, respectively). 

Thus, if you are a medical device manufacturer looking to enter the EU market, you will likely need to work with a Notified Body. In the following sections, we will discuss Notified Bodies, their role in the EU, and how to choose the best one for you. 

What is a Notified Body? 

Notified bodies are independent certification organizations designated by EU Member States to assess if a medical device or system meets the requirements for CE marking. Before your medical device can receive the CE mark, it will likely need to undergo a conformity assessment procedure. 

What is a conformity assessment? It is an audit of your company’s processes and your medical device’s technical data to make sure that they meet the EU’s standards and regulations required to be on the market. During this process, auditors meet with you for multiple days and go through your documentation to check each requirement and notify you of anything that needs to be corrected or is missing.

If the technical documentation meets the requirements, the Notified Body will issue you a certificate, allowing you the legal right to label the assessed medical device with a CE Mark along with a four-digit Notified Body identification number for commercial distribution. After your device has been placed on the market, the Notified Body will be responsible for assessing (auditing) your documentation on a regular basis to make sure it remains compliant. 

What Medical Devices Require a Notified Body? 

Medical devices that belong to Class I and Class A IVDs (the lowest-risk classes) are not required to undergo a conformity assessment and can be self-declared by the manufacturer. However, if the Class I medical device is sterile, has measuring functionality, or is a reusable surgical instrument (also called Class Is, Im, or Ir), then it is still subject to conformity assessment by a Notified Body prior to CE marking. 

Medical devices or systems that belong to medium to high risk classes, including Class IIa, Class IIb, or Class III devices, are required to undergo a conformity assessment by an accredited Notified Body. Additionally, IVD devices designated as Class B, Class C, or Class D require a conformity assessment by a Notified Body. Class A IVDs can be self-declared by manufacturers. 

 

The Role of Notified Bodies

For any medical device to be sold in the EU, it must have a CE mark before it can enter the European market. This can be thought of as its European passport. Notified Bodies act on behalf of the EU member states so, regardless of where the Notified Body is located, its granted CE mark is accepted in all of the supporting EU member states.

According to the EU Medical Device Regulations (MDR) 2017/745 and the In Vitro Diagnostic Regulations (IVDR) 2017/746, Notified Bodies are responsible for the following:

  • Certification and auditing of the manufacturer's Quality Management System or QMS (ISO 13485).
  • Review the medical device technical file and ensure that it meets the level required by the product classification.
  • Auditing essential sub-contractors to guarantee a safe end product. 
  • Confirm the manufacturer has classified their device according to the classification rules defined by EU MDR 2017/745 regulations. In vitro diagnostics are governed by EU IVDR 2017/746 regulations
  • Giving the European Commission or EC Certification - this is the authorization to use its notification number along with the CE mark on your product and its labels.
  • Unannounced audits to check if the production process is appropriately regulated and whether the products comply with the legal requirements. 

While Notified Bodies supply conformity assessment in support of the EU MDR/IVDR General Safety and Performance Requirements (GSPR), it is still your responsibility to ensure that all requirements have been fulfilled. 

How to Choose the Best Notified Body? 

It is important to note that not all Notified Bodies are the same. They differ in what devices they can review, their approach to assessing you have met the regulations, and even their fees and timelines for review. 

Before you choose a Notified Body, your company needs to first qualify and classify your medical device to make sure a conformity assessment is required. Remember, Class I medical devices and Class A IVDs don’t need to use a Notified Body as they can self-declare themselves as meeting the required regulations.

Next, you need to determine the specific MDR codes that apply to your device. MDR codes are what Notified Bodies use to determine if they can review your device. Each Notified Body can review only certain types of devices and the MDR codes are used to distinguish between those types of devices. Designated by the European Commission, MDR codes are based mostly on how the device works. Here are some examples

  • MDA 0101: an active implantable device for monitoring, stimulation, or inhibition (e.g., pacemakers, implantable defibrillators, and neurostimulators)

  • MDA 0201: active non-implantable imaging devices using ionizing radiation (e.g., non-active devices used for imaging, diagnosis, and/or monitoring)

  • MDA 0315: Software

Notified Bodies generally will have a list on their website of MDR codes that they will accept for devices being submitted to them. The list of MDR codes and corresponding types of devices that specify the scope for designation for Notified Bodies can be found in the Implementing Regulation (EU) 2017/2185 of 13 November 2017.

For example, if you have developed an artificial kidney, code MDR 0103 (active implantable devices replacing or supporting organ functions), only five Notified Bodies accept this product code: 

Once you have determined your MDR code you will need to determine which Notified Bodies support the review of those types of devices. 

Where do I find the list of Notified Bodies? 

The European New Approach Notified and Designated Organisations (NANDO) database lists roughly 80 active and accredited Notified Bodies authorized to undertake conformity assessments. These lists are regularly updated and include each Notified Body's identification number and the tasks for which it has been notified. 

Currently, there are 44 Notified Bodies for MDR regulations and only 12 Notified Bodies for IVDR regulations. 

When choosing a Notified Body, keep in mind the following factors to help make the best choice: 

  • Does the Notified Body accept your MDR code? 
  • What is the wait time for review? 
  • Do they have a good reputation? 
  • What is their review process like? 
  • How much do they cost?

It is always a good idea to look into reviews on the Notified Body or talk to others who have used that Notified Body to get an understanding of their experience. 

How much does the audit cost?

One each website, the Notified Body is required to list their fees for the conformity assessment. The costs are different between each notified body so it is worthwhile to take a look. However, because of the wait times it may be in your interest to pay more in order to get a more expedient review. Here are some links to conformity assessment costs at different Notified Bodies.

How long will it take to obtain CE certification from a Notified Body? 

When the new EU medical device regulations MDR 2017/745 and IVDR 2017/746 were released, it took more time than expected for Notified Bodies to ready themselves to offer conformity assessments on the new regulations. This resulted in a shortage of Notified Bodies able to review and a backlog of devices awaiting their CE mark. 

This backlog still exists and has resulted in medical device manufacturers facing slow review times as many Notified Bodies take up to 6 months or more before they are able to begin reviewing applications. 

According to an ongoing survey by the European Commission, over 50% of product certifications had a wait time of more than 13 months. The average time taken to get IVDR QMS and product certificates was between 13 and 18 months, and in 30% of cases, it took 19 to 24 months.  

What this means is that you should shop around at Notified Bodies to see what the wait times are for review. Visit their websites and reach out to see what the typical wait time is for devices that match your MDR code. Some Notified Bodies may not even be accepting new applications. Fortunately though, according to the survey mentioned above, there appear to be Notified bodies that are issuing certifications in less than 6 months. 

Thus, choosing your Notified Body earlier in the regulation process may be recommended to ensure the timely completion of CE application reviews. 

EU Notified Bodies and the UK market

As of 2020, the UK was no longer part of the UE. So, what does this mean for medical device manufacturers? The UK has its own certification, the UKCA mark, which is not the same as the CE mark. The UKCA mark is not recognized in the EU market. 

In the UK medical device market, UK Approved Bodies can administer conformity assessments in relation to UKCA marking in an analogous process to Notified Bodies in the EU. However, UK Approved Bodies cannot conduct conformity assessments for CE marking.

The good news, your EU MDR CE mark (issued by EU-recognized Notified Bodies) is accepted in the UK and will continue to be accepted in the UK until June 2030. 

Conclusion 

To enter the EU market, all medical devices and products are required to have a CE mark. This ensures that devices are safe and effective for the public. Notified Bodies are responsible for conducting conformity assessments and audits before issuing CE marks for medical devices. Not all Notified Bodies are the same and you should determine what Notified Body would be best for you according to its fees, wait times, and acceptance of your products MDR codes. 

Formly AI: Your Partner in Medical Device Certification

At FormlyAI, we understand the complexities of MDR medical device certification. Our service provides a streamlined, efficient path to CE marking and all the tools to ensure your medical device adheres to all necessary EU regulations. All for a fraction of the cost of using traditional consultants. This way you can build your compliance documentation and apply for CE marking in a matter of weeks, not years.  

Learn more about our software and accelerate your path to CE marking with Formly.

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