Pending new approval for your invitro diagnostic medical device (IVD)

Are you sure your approval strategy will get you through the audit in 2022?

Many IVD manufacturers are not aware of the actual time pressure. Also, many lull themselves into a false sense of security when it comes to classification. They are preventing themselves from rapidly introducing new products after 2022 due to having no suitable approval strategy. There is a solution for this.

Are you a Regulatory Affairs Manager or Quality Manager for an IVD manufacturer? Then you are most likely responsible for the timely implementation of the requirements of EU Directive 2017/746/EU on In-Vitro Diagnostics (IVDR) by May 26, 2022. One of your main tasks is classifying the affected product portfolio and ensuring new approval - depending on the class of the product - with or without a notified body, until the IVDR comes into effect.

Managing directors or department heads provide the necessary resources and, if necessary, also plan the products and product versions that are intended to ensure the success of your company in the medium and long-term.

There are three considerations which are of essential importance for a safe approval strategy under the IVDR.

1. Time is of the essence (now more than ever)! 

The start of application of the IVDR on May 26, 2022 was once several years in the future. But since May 2020 we have no longer been counting the years, but the mere months until the IVDR takes effect for you. Many manufacturers also intended to utilize the switch to the MDR to monitor whether the approval strategies in this field function correctly. But nobody could have predicted the pandemic and the resulting coronavirus crisis with the restrictions we are all familiar with. This also meant that the application of the MDR was postponed to May 26, 2021, as the EU Commission announced on April 24, 2020 via the Official Journal of the European Union.

Conversely, the start of application of the IVDR was not postponed and a large number of IVD manufacturers mainly spent the first half of 2020 developing SARSCoV-2/Covid-19 tests. This precious time is now not available for the implementation of IVDR regulations or for planning long-term regulatory strategy.

2. Do you have a rock-solid plan for approval? 

We often find product classifications from IVD manufacturers that have been created without a thoroughly documented intended purpose or for which changes to the intended purpose are still planned. However, classification is not possible without a precise intended purpose. If this is the case for your products, approval is not guaranteed. Why not? It's like building a house without a stable foundation. In our daily consulting practice, we often observe that the intended purpose is not sufficiently documented, or at all. The notified body will then scrutinize your classification and in many cases will issue a classification that is not to your liking and delay the time of market entry.

3. Is the approval strategy future-proof? 

The easiest way of having your products approved under the IVDR is to have the products classified according to the intended purpose and to carry out the conformity assessment as quickly as possible. The problem here, however, is that from Class B onwards, every significant change must be approved by the notified body. This costs time and a lot of persuading. Solving this problem is actually pretty simple: you stay within a generic framework with some of your products and clearly define which components or specific products have critical characteristics. This is the key for a separate classification and thus you have the option of making changes and additions to the product or system on your own.

This helps you restrict the influence of the notified body to the critical products or system components. This has two benefits:

1. You enjoy the freedom to make future changes and save effort, time and money.
2. This separation based on critical characteristics will also make it easier to introduce new products in the future.

3.1. A particular problem: software development

Our customers are used to running very short release cycles, something that is highly valued by their customers. Incorrect classifications will render this impossible in the future because the notified bodies have to be involved in the decision, but are not always immediately available and often have objections. Our concept allows you to retain these short release cycles at least for uncritical components.

The idea for this concept is impressive, it also works, but the implementation is not entirely straightforward. A modular system is often the solution for a sustainable approval strategy.

The Johner Institute approval strategy

If you want to be sure that the notified body will accept your classification and that your strategy is future-proof, then we have the right package for you which guarantees you this.

In this package, our strategy experts offer the following seven-point plan.

Four-hour workshop for initial assessment:

1. We check the intended purpose and advertising claims of your products for critical characteristics. This helps us create the basis for optimized classification.

2. We create a preliminary classification of your products or check your classification. This helps you see the parts you can use a better classification for to your advantage.

3. We develop proposals for product delimitation and coordinate these with your company goals and customer requirements in order to create future-proof conditions for your company.

One to two-day approval strategy work package:

4. We reformulate or rewrite the intended purpose accordingly in order to create the basis for the new classification.

5. We classify your products in such a way that leaves the notified bodies no scope to raise any objections. This gives you the confidence to negotiate with the notified body.

6. We will show you how you can add new products as you wish in the future and make changes to products in order to be as flexible as possible when expanding and developing your products.

Preparation of an expert opinion:

7. We write an expert opinion that supports the line of reasoning behind the approval strategy and classification. In our experience, this alone leads to the notified bodies accepting the classification without objection.

With this seven-point plan, you ensure that

• your intended purpose matches the classification. This will help you prevent inconsistencies with the notified body during the preliminary negotiations for the conformity assessment; 
• you plan the performance evaluation in a targeted manner; 
• (delimited) products fall into lower classes and that, thanks to lower levels of monitoring, you gain more independence from the notified body. This also reduces your monitoring costs; 
• you can easily integrate future products into your product portfolio, even after 2022. This will speed up your approval process considerably; 
• you can make changes to non-critical products or system components independently without having to wait for the notified body to be available and also to avoid the corresponding costs;
• the notified body can concentrate on the essentials in the event of substantial changes to the critical products and system components. You can use our arguments for why connected products and system components do not have to be tested. This saves time and effort. 

In order to develop your individual approval strategy for your products with you, write us an email and we will take you through the approval process. To our knowledge, this is the only product on the market that addresses this issue.

The IVD team of the Johner Institute is available to help you with this.

We are experts in the fields of quality management, regulatory affairs, development, engineering, molecular genetics, biochemistry, laboratory medicine, and the approval of medical devices. We have many years of experience in dealing with notified bodies and can derive procedures and lines of argument from numerous customer projects that are applicable to your approval strategy. As a result, the solution for a fast and long-term approval strategy is often reached in just a few hours.