IVDR compliance made simple – Expert guidance for your business

The In Vitro Diagnostic Regulation (IVDR – EU 2017/746) aim to ensure safe and effective diagnostic tests in the European market. IVDR was adopted in April 2017 and became fully applicable on May 26, 2022. This means that all:

  • New IVD devices need to fullfill IVDR before they are placed on the market
  • IVD devices that were on the market before May 26, 2022 (legacy devices) need to transfer to IVDR within the stipulated transition timelines

At Key2Compliance we offer a range of services both for new IVD and legacy devices. We help IVD manufacturers stay ahead of the competition and maintain their market position.

This page provides information on key changes, timelines, and how to ensure compliance with the new IVDR requirements.

Don't delay - act now to stay ahead in the market

Understanding IVDR

The IVDR (In Vitro Diagnostic Regulation) was introduced to replace the previous In Vitro Diagnostic Directive (IVDD) to address several issues that were identified with the previous regulatory legalislation.

Some of the key reasons why the IVDR was introduced include:

Advances in technology

The need to address advances in technology:
The IVDR consider software and other technologies that were not so advanced in the 1990th when the IVDD was written.

Robust regulatory framework

The need for a more robust regulatory framework:
IVDD was considered too vague, lacking clear guidance for manufacturers and regulators. IVDR enhances certification with a strict classification system, more transparency, and greater participation of notified bodies.

Enhance patient safety

The need to enhance patient safety:
The IVDR places a greater emphasis on patient safety by requiring legal manufacturers to provide more data on the safety and performance of their devices and by introducing a system for tracking and tracing devices.

Key changes from IVDD to IVDR

The IVDR has introduced stricter classification rules, including Notified Bodies at a higher extent. All IVD devices in the classes B, C and D requires a notified body.

The IVDR has expanded the scope of the previous In Vitro Diagnostic Directive (IVDD) to include new types of tests. The IVDR requires manufacturers to provide more information to regulatory authorities, healthcare providers, and patients.

The IVDR requires IVDs to meet more stringent performance requirements, including requirements related to performance evaluation and clinical data.

All IVDs a required to have a Person Responsible for Regulatory Compliance (PRRC). The PRRC needs to fulfill certain training and experience requirements.

The IVDR requires manufacturers to establish and maintain a post-market surveillance system to monitor the safety and performance of their devices after they are placed on the market.

Classification and timeline

IVDs in the EU are categorized by four risk classes, A, B, C and D, with varying levels of patient and public health risk. New IVD devices need to fulfill IVDR before they are placed on the market. IVD devices that were on the market before May 26, 2022 (legacy devices) need to transfer to IVDR within the stipulated transition timelines shown below.

ivdd-doc

Six steps to meet the IVDR requirements

It is important for legal manufacturers to plan the IVDR fulfillment thoroughly to allow sufficient time to address compliance activities.

Step 1

Qualification and classification
Initial qualify that your product is a IVD device by reviewing the IVD definition in IVDR. IVDR Article 2 Definitions.Secondly classify your IVD device using the classification rules. IVDR Annex VIII Classification rules.
The four risk classes are: A, B, C and D. The risk class stipulates the level on the technical documentation and the need of Notified Body.

Step 2

Prepare technical documentation
Prepare or update the technical documentation according to IVDR Annex II Technical documentation, and review any need for collection of clinical data.

Step 3

Quality management system (QMS)
Prepare or update your QMS according to IVDR Annex IX, chapter I QMS

Step 4

Notified body
If your device is class A, than you can self-certificate and place it on the European market. If your device is class B, C or D than you will send the technical documentation for review to your Notified Body. The notified body will review your technical documentation and conduct audits of your QMS and manufacturing facilities.

Step 5

Receive certification
If your device meets the applicable requirements, the Notified body will issue a certificate of conformity. The certificate will confirm that your device complies with the IVDR and can be placed on the European market.

Step 6

Maintain compliance
After self-certification or receiving a Notified body certification, you must maintain compliance with the IVDR’s requirements and continue to monitor and assess the safety and performance of your device.

How Key2Compliance can help you become IVDR compliant

Are you ready to implement IVDR but don’t know where to start? Our comprehensive services cover training for IVD companies who wish to carry out the implementation by themselves, to support with all of it.

Our full service can for example contain:

We can plan and manage your entire IVDR transition for you.

We educate personnel in our “open” trainings or perform customized trainings for you as a company.

We qualify and classify your device.

We perform GAP analysis of your technical documentation and QMS.

We identify standards, guidance documents and other applicable regulations that concern your devices.

We create or update your technical documentation and labeling so that it complies to IVDR, identify standards, guidance documents and other applicable regulations.

We plan and perform your performance evaluation.

We plan and perform your clinical investigations.

We plan and help you perform a biological evaluation, when needed.

We help with documentation of chemical, physical and biological properties (GSPR 10)

We help you establish REACH compliant Safety Data Sheets

  • QMS: We create or update your QMS to comply to IVDR (including your quality agreement templates) while maintaining an effective and easy to use system.
  • eQMS: We transform your current QMS to an effective eQMS to minimize your paperwork.

We can assess your regulatory data and help you with planning your post market activities to improve your performance evaluation.

  • PRRC: For companies with less than 50 employees we offer PRRC consultants.
  • Quality Manager: We offer part-time or full-time Quality Manager consultants.

We plan and perform your internal and supplier audits.

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Contact Key2Compliance today to learn more about how we can help your company navigate the IVDR. Our team of experts help IVD companies identify the changes needed to meet requirements, develop a roadmap for compliance, and guide you through the entire process. Key2Compliance also offers training and workshops on the IVDR to help manufacturers understand requirements and how they will affect your devices.

We are ready to assist you with all your regulatory needs, so you can focus on what really matters.

FREE WEBINAR

The IVDR challenges – do you have everything under control?

Listen to our specialists Susanne El Makdisi, Susanne Grimsby and Emily Malmberg discussing the challenges of IVDR. The 30 minute webinar takes you through what the IVDR requirements entail and how to meet compliance in a time- and cost efficient manner. 

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Overcoming challenges while establishing Regulatory strategy

Click the image to read the blog written by our specialist Julia Selmani and find out what you need to consider when you plan your regulatory strategy, when and how to start, and the key elements to take into account when establishing your regulatory strategy.

ARTICLE

Compliance Expert Insights on IVDR: Understanding the Impact

This article covers the impact of the new In Vitro Diagnostic Medical Device Regulation (IVDR) and how it affects IVD manufacturers. Key2Compliance’s expert consultants, Susanne Grimsby and Emily Malmberg, provide valuable insights on navigating the certification process, addressing challenges, and ensuring compliance. 

FAQ

IVDR stands for In Vitro Diagnostic Regulation. It is a regulation in the European Union that sets the standards for in vitro diagnostic medical devices (IVDs). It was adopted in 2017 and became applicable in May 2022.

IVDR applies to all manufacturers of in vitro diagnostic medical devices who intend to place their products on the market in the European Union.

IVDR introduces several changes to the regulation of IVDs in the European Union. Some of the key changes include the introduction of stricter requirements for clinical evidence, The introduction of person responsible for regulatory compliance (PRRC), increasing requirements on post market surveillance (PMS), increasing requirements on quality management systems and the establishment of a unique device identification (UDI) system.

Manufacturers can comply with IVDR by ensuring that their IVDs meet the requirements set out in the regulation. This includes harder requirements on clinical data, having a Person responsible for regulatory compliance (PRRC), post market surveillance (PMS) system, implementing a quality management system, and registering their devices with the European database on medical devices (EUDAMED).

Some common challenges include identifying the correct classification for their IVD device, if applicable contracting with a notified body, ensuring their technical documentation meets IVDR requirements, updating their quality management system (QMS), and training staff on new regulations and processes. Additionally, the shortage of notified bodies has led to delays and increased competition for their services, making it even more important for companies to plan and prepare ahead of time.

A notified body is an organization designated by a European Union member state to assess the conformity of certain products with the relevant EU legislation, such as the IVD devices class B, C and D. They are responsible for performing conformity assessments, which involves reviewing technical documentation, conducting audits, and issuing certificates of conformity. You need a notified body, if you have a divice classified as B, C or D to certify your IVD device for CE marking and to sell it on the EU market.

You should choose a notified body that is designated for the type of IVD device you are manufacturing, as well as one that has experience in your specific field. You should also consider their availability, fees, and reputation. The European Commission maintains a list of designated notified bodies on the NANDO database, which you can use to find and compare potential candidates.

It depends on the device and the level of clinical evidence required for compliance. Some devices may require new investigations, while others may be able to use existing data. It is important to review the regulation and seek guidance from notified bodies or regulatory consultants.

Yes, for a limited time if you don’t do any significant changes. But all new IVD devices need to directly comply to IVDR directly.

IVDR may pose a significant challenge for small businesses and startups due to the increased requirements for clinical evidence, performance evaluation, and economic operators. However, there are resources available to help companies navigate the compliance process.

The clinical evidence requirements under the IVDR are more stringent than those under the IVDD, so you may need to generate additional clinical data to demonstrate compliance with the new regulations. However, you may be able to use some of the same data if it is still relevant and up-to-date, and if it meets the new requirements. You should consult with a notified body or regulatory expert to determine what evidence you will need for IVDR compliance.

The timeline for certification can vary depending on the device classification, the availability of notified bodies, and the complexity of the device. It is recommended that companies begin the process as soon as possible to avoid delays.

There are no general exemptions or exceptions to IVDR compliance, but some devices may fall under certain derogations. It is important to review the regulation carefully to determine if any derogations apply.

Non-compliance with IVDR can result in serious consequences for manufacturers. This includes the inability to place their products on the market in the European Union and could incur financial penalties.

The European Commission website provides comprehensive information about IVDR, including guidance documents, FAQs, and other resources. Additionally, manufacturers can consult with notified bodies and regulatory experts to ensure compliance with the regulation.

Analytical sensitivity, analytical specificity, trueness (bias), precision (repeatability and reproducibility), accuracy (resulting from trueness and precision), limits of detection and quantitation, measuring range, linearity, cut-off, including determination of appropriate criteria for specimen collection and handling and control of known relevant endogenous and exogenous interference, cross-reactions.

Yes if there are parts in direct, or indirect contact with the patient.

Yes, if the it contains substances in amounts that are classified as hazardous according to CLP or if the requirements of article 31.3 in the REACH regulation are met.

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