IVDR 2017/746: Ensuring Safe and Effective In Vitro Diagnostic Medical Devices

The In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746 was set up by the European Union on April 5, 2017. It aims to make a strong, clear, and lasting rule for in vitro diagnostic medical devices¹. This rule replaces the old In Vitro Diagnostic Medical Devices Directive 98/79/EC. It sets higher standards for the quality and safety of in vitro diagnostic (IVD) devices².

Contents

The IVDR strengthens important parts of the old rules, like checking how well devices work and watching over the market. This helps make patients and users safer and healthier¹. It makes sure all in vitro diagnostic medical devices follow the same rules, making it easier to move goods around the European Union¹. The rule also has special rules for devices that use ionizing radiation, making sure workers are safe¹.

Key Takeaways

The IVDR 2017/746 sets up a new, strong rule for in vitro diagnostic medical devices in the European Union.
The goal is to make sure in vitro diagnostic medical devices are safe and healthy for patients and users.
The IVDR makes sure in vitro diagnostic (IVD) devices are of high quality and safe.
The rule makes it easier to sell in vitro diagnostic medical devices across the European Union.
The IVDR strengthens important parts of the old rules, like checking how well devices work and watching over the market, to improve health and safety.

Introduction to the In Vitro Diagnostic Medical Devices Regulation

The In Vitro Diagnostic Medical Devices Regulation (IVDR) was adopted in 2017 by the European Parliament and Council. It replaced the old In Vitro Diagnostic Medical Devices Directive. This new rule aims to create a strong, clear, and lasting way to regulate in vitro diagnostic medical devices in the European Union (EU)³.

The IVDR’s main goals are to make medical care safer, make sure all can access the market fairly, and keep up with new science and technology³. It’s a big step up in managing IVDR, offering detailed rules to make sure these important medical tools are safe and work well.

The IVDR started in the EU and Northern Ireland on May 26, 2021, and 2022, respectively³.
The Medical Devices In Vitro Diagnostic Devices Amendment Regulations 2024 took effect on March 21, 2024, adding rules for Northern Ireland³.
Class I medical device and Class A IVD makers in Northern Ireland can self-declare their products meet the MDR and IVDR standards until certain dates³.
Qualifying products from Northern Ireland can still be sold in Great Britain forever with a valid CE mark, thanks to the UK Internal Market Act 2020³.
Health centers in Northern Ireland applying for special MDR and IVDR status must meet safety and performance rules, have a quality system, explain why they need the exemption, and keep all the needed documents³.
Importers and distributors in Northern Ireland must follow many rules, like having a CE mark, registering in Eudamed, keeping complaint records, and letting the MHRA do inspections if needed³.

The IVDR marks a big change in how in vitro diagnostics are regulated in the EU. It aims to make patients safer and encourage new ideas in the EU medical device field³.

This new rule sets up a detailed and united way to make sure in vitro diagnostic medical devices sold in the EU are safe, quality, and work well. This will help healthcare workers and patients a lot³.

Key Elements of the IVDR

The IVDR 2017/746 brings new rules to make IVD devices safer and fairer⁴. It focuses on better supervision of notified bodies, a new risk-based system for IVDs, strict checks, and more studies⁴. It also makes the IVD supply chain more open and accountable⁴.

Reinforced Supervision of Notified Bodies

Notified bodies are key in the CE marking process for medical devices⁴. They check technical documents and give CE certificates⁴. The IVDR makes sure these bodies are good at their job, with most IVD products needing their approval⁴.

Risk Classification for IVDs

The IVDR has a new risk-based system for IVDs, with four classes (A, B, C, D)⁵. Class A is the lowest risk, and Class D is the highest⁵. The risk level decides how much oversight a device gets⁵.

The IVDR looks at the whole life of IVD devices, focusing on safety, openness, and managing risks⁴. It aims to make patients safer, improve health outcomes, and help IVD makers and healthcare workers⁴.

“The IVDR introduces a risk-based classification system for IVDs, with four classes (A, B, C, D) based on the intended purpose and inherent risks.”⁵

Scope and Definitions under the IVDR

The IVDR (In Vitro Diagnostic Regulation) 2017/746 clearly outlines its scope. It defines in vitro diagnostic medical devices and distinguishes them from other products. These include medical devices, general laboratory products, and research-use only products⁶. The regulation also provides detailed definitions for key terms related to IVDs, economic operators, conformity assessment, clinical evidence, and post-market surveillance.

Under the IVDR, in vitro diagnostic medical devices are defined as any medical device used for examining specimens from the human body. This includes blood and tissue samples. The goal is to provide information on physiological or pathological processes, or to determine the safety and compatibility with potential recipients⁶. The regulation sets specific rules for the development, manufacture, and marketing of these devices. It ensures they meet stringent safety and performance requirements.

IVD Classification	Risk Level	Examples
Class A	Low to Moderate Risk	General Controls
Class B	Moderate to High Risk	Special Controls
Class C	High Risk	Pre-market Approval
Class D	High Risk	Transmissible Disease, Blood screening, High-risk disease, and High-risk Blood groups (Pre-Market Approval)

The IVDR’s scope extends beyond traditional IVD products. It includes a wide range of devices, accessories, and components used in in vitro diagnostic procedures⁷. This ensures comprehensive oversight and regulation to safeguard public health and patient safety in the European Union.

“The IVDR clearly defines the scope of in vitro diagnostic medical devices and establishes a robust regulatory framework to ensure their safety and effectiveness. This is a critical step in protecting public health and patient well-being.”

As the IVDR continues to be implemented, healthcare professionals, manufacturers, and regulatory authorities must familiarize themselves with the evolving landscape of IVD regulations and definitions. This ensures compliance and delivers safe, high-quality diagnostic solutions⁸.

In vitro diagnostic medical devices regulation: Essential Requirements

The IVDR (In Vitro Diagnostic Medical Devices sets clear rules for in vitro diagnostic (IVD) medical devices⁹. It makes sure IVDs are safe and work right. This includes things like risk management and protection from radiation⁹.

General Safety and Performance Requirements

The IVDR has rules for the safety and performance of IVDs⁹. Companies must prove their devices work as claimed. Notified Bodies check if medium- and high-risk devices are up to standard, sometimes without warning⁹.

Technical Documentation and Clinical Evidence

The rule also talks about the technical documents and evidence needed for IVDs⁹. It uses a system to sort IVDs into classes A, B, C, and D based on their risks⁹. Companies must gather and look at data to show their devices meet the rules⁹.

IVDR essential requirements

The IVDR updates the rules for IVDs to make them safer and more effective⁹. Following the rules helps make sure products are safe for patients⁹.

Requirement	Description
Risk Management	Companies must have a strong risk management system to spot, check, and control risks in their IVDs.
Chemical, Physical, and Biological Properties	IVDs need to be made to have the right chemical, physical, and biological properties for their use.
Protection Against Radiation	IVDs that give off radiation must be made to keep patients, users, and others safe from too much radiation.

“The IVDR is a big step forward in making sure in vitro diagnostic medical devices are safe and work well in the European Union.”

Following the IVDR helps show that IVDs are safe, work well, and are right for their job⁹. This builds trust in the medical device field, helping healthcare workers and patients⁹.

Conformity Assessment and CE Marking

The In Vitro Diagnostic Devices Regulation (IVDR) sets clear steps for manufacturers to follow. They must show their devices meet the EU’s strict safety and performance standards to get the CE marking¹⁰. This is key to legally sell IVDs in the European Union.

Manufacturers go through a detailed check by Notified Bodies, watched by EU authorities¹¹. They need a strong Quality Management System (QMS) that follows EN ISO 13485. They also must have a Person Responsible for Regulatory Compliance (PRRC) and detailed technical documents on the device’s design and use.

The risk level of the IVD determines how much Notified Body help is needed, from Class A (low) to Class D (high)¹¹.
For high-risk IVDs, like Class C and D, a detailed audit by a Notified Body is required. They might also get scientific advice from EU Reference Laboratories to check the device’s performance¹¹.
After passing the assessment, the CE marking is given. This means the IVD is safe and effective for the EU market¹².

The CE marking shows the IVD has been checked and is safe and effective¹². Manufacturers must keep their devices in line with the IVDR at all times. This includes ongoing checks and reporting after the product is on the market.

“Navigating the IVDR’s conformity assessment and CE marking is complex but vital for IVD makers wanting to enter the European market. Good planning, strong quality systems, and working closely with Notified Bodies are key to success.”

Unique Device Identification and Traceability

The In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746 has brought in a strong system for Unique Device Identification (UDI). This makes it easier to track in vitro diagnostic (IVD) medical devices¹³. Now, manufacturers must give each device a UDI. This UDI has special info to make the device and its details clear¹³.

This UDI system is for all IVD devices, except for custom-made and study devices¹⁴. Companies must put the UDI and details of their products in the EUDAMED database¹⁴. The EUDAMED database is getting ready to help with this¹³.

The UDI Helpdesk gives help on how to use UDI, label devices, and register them¹³. Also, companies must use the European Medical Device Nomenclature (EMDN) for EUDAMED registration¹³. This nomenclature is on the EUDAMED public site¹³.

Timeline for UDI and Device Registration	Requirement
26 May 2021	Obligation for UDI assignment begins for medical devices
26 May 2022	Obligation for UDI assignment begins for in vitro diagnostic medical devices
26 November 2022	Obligation for submission of UDI data in EUDAMED begins for medical devices
26 November 2023	Obligation for submission of UDI data in EUDAMED begins for in vitro diagnostic medical devices

The IVDR’s UDI system is key for making sure IVDR UDI and device traceability are safe and traceable in the European Union¹³¹⁴.

Post-Market Surveillance and Vigilance

The IVDR makes the rules for watching over medical devices after they hit the market stricter. Now, makers must set up a system to keep track of how their devices work and stay safe¹⁵. They also need to join a watch system to share any issues or fixes needed for their devices¹⁵.

Market Surveillance and Vigilance System

The Eudamed2 database is key in making sure medical devices are watched closely and safely¹⁵. It’s a secure online spot that holds info on who makes and sells devices, and the details of their certificates¹⁵. This info helps make sure devices are safe and work right¹⁵.

Only certain groups can see Eudamed2, like national authorities and the European Commission¹⁵. This helps everyone follow the same rules for medical devices and share info fast¹⁵. The success of Eudamed2 is checked and shared openly, making sure we know it’s doing its job¹⁵.

The IVDR and the MDR both call for strong systems to watch over devices after they’re sold¹⁶. They both have deadlines for different reports¹⁶. The main difference is how they watch over devices based on their risk level and type¹⁶.

Under the IVDR, some devices need Post-Market Surveillance Reports, while others need Periodic Safety Update Reports¹⁶. All in vitro diagnostic devices must tell the authorities about any steps taken to fix risks¹⁶.

“The effectiveness and value of Eudamed2 have been assessed, with the results of its evaluation publicly accessible to ensure transparency and accountability in the oversight of in vitro diagnostic medical devices.”

Global Convergence and International Harmonization

The European Union’s In Vitro Diagnostic Medical Devices Regulation (IVDR) works to match international standards. It aims for IVDR global convergence and international harmonization in in vitro diagnostic medical devices. It includes rules on Unique Device Identification, safety, technical documents, and more that match international best practices¹⁷.

Getting regulations to work together is key for international cooperation. The World Health Organization (WHO) says it’s vital to follow international standards for medical devices. This ensures products are safe and work well¹⁷.

The IVDR follows international advice to help bring everyone in line. The WHO suggests updating rules often to keep up with new science and standards¹⁷. This helps countries work together better and share resources.

The World Health Organization says making rules the same worldwide can save resources¹⁷. This could mean more money for improving how we watch over products, helping healthcare, and treating patients.
International groups like the International Organization for Standardization (ISO) set the standards for medical devices¹⁷.
The WHO says good rules are important for making fair and timely decisions about medical products¹⁷.
The WHO believes in making decisions based on solid science and international standards¹⁷.

Watching over products after they’re sold is now a big focus. ISO rules require companies to have systems for this¹⁷. The IVDR follows these global standards to make sure devices are safe and effective everywhere.

The Global Harmonization Working Party (GHWP) is working hard to make IVDR global convergence and international harmonization a reality. With 32 members, it covers a big part of the world’s population¹⁸. GHWP has made a lot of progress, creating guidelines and helping countries work together.

GHWP Achievements	Details
Guidance Documents	In five years, GHWP has released 10 guidance documents, with 4 linked to the International Medical Devices Regulatory Forum (IMDRF) Work Group documents¹⁸.
Working Groups	GHWP has 9 Working Groups (WG1 to WG9) focusing on different aspects of medical device regulations¹⁸.
Endorsement Process	The GHWP TC has a 4-step procedure for endorsing documents, starting from Draft, Proposed, Proposed Final, to Final stages¹⁸.

The IVDR and groups like the GHWP show a strong commitment to IVDR global convergence and international harmonization. This is key for making sure medical devices are safe, work well, and available worldwide.

Transition Timelines and Deadlines

The new In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746 will start in the European Union (EU) on May 26, 2022¹⁹. IVD devices already certified under the old rules can still be sold for a while, based on their risk level¹⁹.

Manufacturers need to make sure their IVDs meet the IVDR rules by the set deadlines to stay in the EU market²⁰. The time to switch over varies by device type, with dates from December 31, 2027, to December 31, 2029¹⁹.

Class A (sterile products): Extended transition until December 31, 2029¹⁹
Class B devices: Transition period until December 31, 2029¹⁹
Class C devices: Deadline until December 31, 2028¹⁹
Class D devices: Transition period until December 31, 2027¹⁹

Manufacturers should not wait to follow the IVDR rules, as these deadlines are firm²⁰. Notified bodies are now using the new rules in their work. They advise manufacturers to keep up with their IVDR plans to avoid delays and get through conformity assessments smoothly²⁰.

The switch to IVDR brings both challenges and chances for manufacturers. Knowing the deadlines and acting early helps companies move smoothly to the new rules. This keeps them in the market and ensures they offer safe, effective IVDs to patients²¹.

Conclusion

The IVDR regulation sets a new standard for²² in vitro diagnostic medical devices in the EU. It makes sure they are safe, work well, and can be sold²³. This new rule follows global best practices to make healthcare safer, more open, and to encourage new ideas in the IVD field²⁴.

This new rule has a stronger way of classifying IVDs. It means²³ 70%-90% of these devices need to get certified by a notified body. This is a big jump from the 15% needed before²². The goal is to make sure IVDs in the EU are safe and work as they should²².

As the IVDR takes over from the old rule, the medical device industry is facing big changes²³. With only 4 notified bodies ready and a long process to get more, there are worries about meeting the 2022 deadline²². But, the IVDR is a big step towards making the²² in vitro diagnostics sector in the European Union better. It will make patients safer and push innovation in healthcare.

FAQ

What is the IVDR (Regulation (EU) 2017/746)?

The IVDR is a new EU rule. It sets up a strong, clear, and lasting framework for in vitro diagnostic medical devices. It ensures safety and health for patients and users, and supports innovation.

What are the key objectives of the IVDR?

The IVDR aims to boost clinical safety and ensure fair market access for makers and healthcare pros. It also keeps up with technical advances and medical science progress.

What are the key regulatory elements reinforced by the IVDR?

The IVDR strengthens the oversight of notified bodies and the risk classification of IVDs. It also covers conformity assessment, performance evaluation, vigilance, and market surveillance.

How does the IVDR define the scope of in vitro diagnostic medical devices?

The IVDR clearly outlines its scope. It defines in vitro diagnostic medical devices and separates them from other products like medical devices, general lab products, and research-use only items.

What are the essential requirements for IVDs under the IVDR?

The IVDR sets out key requirements for IVDs. These include general safety and performance standards. Manufacturers must make sure their IVDs meet these standards. This includes risk management, chemical, physical, and biological properties, and protection against radiation.

What is the conformity assessment procedure under the IVDR?

The IVDR has a conformity assessment procedure. Manufacturers must follow this to show their IVDs meet the regulation’s standards and get the CE marking. This involves assessment by notified bodies, which are checked by authorities.

What is the Unique Device Identification (UDI) system introduced by the IVDR?

The IVDR requires a Unique Device Identification (UDI) system for better IVD device traceability. Manufacturers must give their devices a UDI. This UDI includes data to uniquely identify the device and related info.

What are the post-market surveillance and vigilance requirements under the IVDR?

The IVDR ups the ante on post-market surveillance and vigilance. Manufacturers must set up a system for post-market surveillance to gather and analyze data on their IVDs’ performance and safety. They also need to join a vigilance system to report incidents and info on device safety and performance.

How does the IVDR align with international guidance and standards?

The IVDR works towards global regulatory harmony for in vitro diagnostic medical devices. It covers things like Unique Device Identification, safety and performance standards, technical documents, classification rules, conformity assessment, and clinical evidence.

What are the key transition timelines and deadlines for the IVDR?

The IVDR will start fully applying in the EU from May 26, 2022. IVD devices already certified under the old directive can still be sold for a while, based on their risk class.