The transition from IVDD (98/79/EC) to IVDR (EU 2017/746) has been overwhelming for many manufacturers, especially those that have never worked with a notified body because they were previously able to self-certify under the IVDD. Many are now realizing that the IVDR notified body application process is rigorous and time-consuming. Understanding what is involved, the most common mistakes, and how to submit a high-quality application is essential for starting the IVDR certification process on the right foot.
In addition to the transitional provisions, time is an important element to consider for enabling an effective and successful IVDR conformity assessment process, which starts with the notified body application. A team NB MD survey published in May 2022 indicates that notified bodies have received only 14.9% of IVDR applications at the end of 2021 in comparison with total valid IVDD certificates.
The number 14.9% is, in fact, even much lower because about 80% of IVD products on the market have been self-certified under the IVDD. With only seven IVDR notified bodies, capacity issues are obvious, which is why time is such an important consideration.
The IVDR Notified Body Application Process
When a manufacturer engages a notified body, one of the first steps in completing an application is to start the quotation process. The notified bodies use the terms “pre-application” and “application” processes, which are governed by the IVDR Annex VII (4). The main difference is that pre-application activities are the foundation of a formal contract between the manufacturer and the notified body. The application activities start formally after the contract has been signed and consist of a thorough review of all information provided in the pre-application stage to assess completeness and accuracy.
Pre-application activities are the key to receiving an accurate contract with few or no surprises, such as changes to the statement of work once the contract has been initiated. Information is typically requested in the form of a spreadsheet-based checklist that includes general company information and detailed information on the entire product portfolio, company quality management system (QMS) and involvement of economic operators as applicable. In order to get an accurate statement of work, the notified body needs detailed, complete and accurate information.
Detailed product information includes:
- Intended purpose statements
- Classification of each product, including applying classification rules according to Annex VIII
- Assignment of regulatory codes, such as European Medical Device Nomenclature (EMDN) codes and specific IVDR codes listed in the Implementing Regulation (EU) 2017/2185
These regulatory codes reflect the intended purpose through the main IVR codes according to (EU) 2017/2185 and EMDN. Another code reflecting the intended purpose is the IVS code according to (EU) 2017/2185, which identifies the intended user (near-patient testing, self-tests, etc.) and/or specific types of an IVD (software, instrument, sterile IVD, etc.). Additional horizontal codes of (EU) 2017/2185 apply to the examination procedure through IVP codes, manufacturing technologies through IVT codes and clinical disciplines through IVD codes.
The regulatory codes have two main functions. First, the notified bodies group the IVD products into families:
- Class C: Generic groups based on fourth-level EMDN and IVP code
- Class B: Product categories based on the IVR code
From these families, they select the required number(s) of representative sample(s) per group(s) for technical documentation assessment which will be stated in the statement of work.
Second, the IVDR codes according to EU 2017/2185 represent the notified body designation scope and are used to assess whether the notified body has sufficient and qualified resources to perform the technical documentation assessment.
Information on the company QMS and involvement of economic operators includes:
- Identification of all design and manufacturing sites relevant to the product portfolio
- Identification of crucial supplier and/or critical subcontractors as well as relevant quality management certificates as applicable
- EU authorized representatives
Based on this information, the notified body will determine the scope of work for the IVDR application. When the portfolio consists of 100 or more products, it’s easy to see how teams might get overwhelmed with the notified body application process, especially if there are no existing systems or processes for this type of work.
Challenges With IVDR Notified Body Application Forms
Be aware of the potential pitfalls related to the completion and understanding of the IVDR notified body application forms.
Copy/paste errors, misspellings and other mistakes can lead to inconsistencies that will impact the quality of the application.
Incorrectly classifying and/or selecting applicable classification rules according to Annex VIII will delay the application process. The classification guidance MDCG 2020-16 rev. 1 is a must-read for all who are in charge of determining the classification. The guidance provides some helpful examples and exclusions per classification rule.
Incorrect Assignment of Regulatory Codes
For each device, the correct regulatory, EMDN and IVDR codes according to 2017/2185 must be assigned. The Implementing Regulation 2017/2185 alone contains a list of 80 codes, and the EMDN codes have significantly more. Notified bodies use these codes in the application stage to group devices into product families, which is an essential step for selecting representative sample(s) per group for technical documentation assessment(s).
Incorrect grouping at the notified body application stage can lead to significant delays and unexpected costs because the notified body has to start the application and quote process from the beginning with any new groups that are identified during the review process.
Some manufacturers are uncertain what EMDN codes to use when their technology and/or type of IVD (for example, calibrator, control, software, etc.) is not clearly addressed in the existing EMDN code list. Understanding and correctly assigning the IVDR codes according to EU 2017/2185 can be very challenging. MDCG 2021-14 Explanatory note on IVDR codes has some guidance on how to apply these codes and provides a table with examples for each of the 80 codes.
Broad Intended Purposes
Assigning the correct codes for devices with a broad intended purpose (IP) can be quite challenging. The best practice is to assign all IVR codes that are relevant to the IP statement. The assignment of IVR 0600 codes, which cover the majority of clinical chemistry products, is particularly difficult, and an understanding of the exact IP is needed. For example, is the product used for screening a specific disease, to monitor or both? Does the device monitor a specific disease or a physiological status? Working with an expert who understands these nuances can make the process more efficient by ensuring that all applicable codes are used.
During the application process, the notified body provides limited resources to support the technical aspects of the application because you are not yet a client. Additionally, the capacity bottlenecks will impact response time to any technical questions. Therefore, a complete and accurate application is crucial for speeding up the entire pre-application process so you can get a foot in the door.
Risks of Submitting a Poor-Quality IVDR Notified Body Application
Although it may be tempting to complete the pre-application forms as quickly as possible, sacrificing quality for speed could actually backfire. A poor-quality application can have negative consequences, such as:
Pre-application activities can take up to six months to compile all of the information. Lack of specificity and inconsistencies can lengthen that process, so it’s best to be as complete and accurate as possible with the initial application.
Notified body quotes are determined by the number of product families and the details within them. If this information is incorrect, quotes will be inaccurate, and you might have to submit new applications for additional work.
Delay to Market
Setbacks in the application process can lead to major delays in certification, which can ultimately lead to costly delays to market.
Tips for a High-Quality IVDR Notified Body Application
The more accurate you are, the more precise your quote will be. Lack of accuracy could lead to clarifying questions, which will extend the time it takes to complete the application process. Pay special attention to the classification, classification rationale and regulatory codes reflecting the intended purpose (EMDN, IVR) and examination procedure (IVP).
Do a Quality Check
Check for inconsistencies, errors and completeness before submitting your application. It’s not uncommon for inconsistencies to arise, especially if multiple teams are working on different sections. A thorough review of the pre-application forms can save you time and money in the long run.
Work With an Expert
Navigating regulatory codes is not easy, especially when you don’t have the necessary expertise on your team. Working with a regulatory expert can help ensure that your application is accurate and complete.
How RQM+ Helps
Understanding the impact of the intended purpose statement and reshaping it as needed all starts at the pre-application stage. RQM+ offers a range of services to support the IVDR notified body application process. Through our application check service, we help clients complete the pre-application process to submit the required checklists. Our flexible approach allows us to start from scratch, fill in the gaps or review a completed application before it’s submitted.
When you work with RQM+ to complete or review your pre-application forms, you can potentially:
- Shorten the timeline.
- Provide more accurate entries.
- Get more accurate quotes.
After the initial application is complete and work with the notified body begins, we offer technical documentation mock audit services as a final step to verify the compliance and consistency of your technical documentation submission. Our technical screen service offers a lighter approach to verifying your technical documentation compliance by screening key focus areas such as classification, intended purpose and clinical evidence approach.
RQM+ offers flexibility that allows you to choose the services you need to supplement your team at any point in the IVDR application process. For the best and fastest result, outsource everything to our expert team.
For a closer look at other IVDR topics, such as post-market surveillance, QMS audits and more, check out our on-demand webinar, “EU IVDR: Intriguing Insights, Recommended Actions, and a Look Towards the Future.”