IVDD 98/79/EC: The EU's Directive for In Vitro Diagnostic Medical Devices

The IVDD 98/79/EC is the EU’s rulebook for in vitro diagnostic (IVD) medical devices¹. It was made on October 27, 1998. This rule helps IVD devices move freely in the EU while keeping everyone safe². It has been updated by other laws over time¹.

Contents

This rule is part of the EU’s medical device laws, but it focuses on IVD devices². It covers many types of IVD devices, including those that use X-rays, and sets rules for their safety and quality².

The IVDD 98/79/EC makes sure IVD devices can move easily in the EU without causing problems². It uses standards from groups like the European Committee for Standardization (CEN) to keep devices safe and effective¹².

Key Takeaways

The IVDD 98/79/EC is the EU’s directive that establishes harmonized rules for in vitro diagnostic medical devices.
The directive aims to ensure the free movement of IVD medical devices within the EU while maintaining a high level of health protection.
It defines the essential requirements for IVD medical devices, including safety, performance, design, and manufacturing standards.
The directive incorporates the use of harmonized standards developed by recognized bodies like CEN and Cenelec.
Manufacturers are responsible for determining and indicating the device’s viable period due to performance deterioration over time.

Introduction to the IVDD

The In Vitro Diagnostic Directive (IVDD) 98/79/EC was introduced in late 1998. It became mandatory on December 7, 2003³. This directive aims to ensure the safety, quality, and performance of In Vitro Diagnostic medical devices (IVDs)³ sold in the European Economic Area (EEA). The EEA includes the 27 EU member states, Iceland, Liechtenstein, and Norway³.

Objectives and Scope of the Directive

The main goals of the IVDD are to make national laws the same and ensure IVD devices move freely in the internal market. It also aims to keep a high level of health protection for patients, users, and others³. The directive covers a wide range of IVD products, like HIV test kits and blood glucose meters³.

Harmonization of National Legislation

The IVDD makes national laws the same to meet its goals. It replaces old national laws with common rules for IVD devices³. This makes sure there are no differences in laws about the safety and performance of IVD devices across the EU³.

The IVDR, which started in 2017, makes the rules for IVD devices stricter in the EU⁴. Now, products need a CE mark to show they meet safety and quality standards⁴. About 80% of IVD devices must go through checks by a notified body⁴.

Manufacturers now need to show that their devices work well and keep track of how they perform after they’re sold⁴. They also have to prepare a Declaration of Conformity and use an EU unique identification (UDI) system⁴. All devices sold in the EU must be listed in the EUDAMED database, run by the EU Directorate General for Health and Food Safety⁴.

Harmonization of IVD Regulations	IVDD 98/79/EC	IVDR 2017/746
Objective	Ensure the free movement of IVD devices within the internal market and maintain a high level of health protection	Introduce a more stringent regulatory environment for in vitro diagnostic medical devices in the EU
Key Changes	– Harmonize national legislation across member states – Replace national provisions with common, essential requirements for IVD devices	– Require CE marking to show compliance with essential safety and administrative requirements – Approximately 80% of IVD devices require notified body involvement for conformity assessment – Mandate clinical evidence, post-market surveillance, and Declaration of Conformity – Implement EU unique identification (UDI) system – Require device registration in EUDAMED database

“The IVDD harmonizes the national legislation of member states, replacing corresponding national provisions with common, essential requirements for IVD devices.”

In summary, the IVDD and the IVDR have been key in making IVD device rules the same across the European Union. They ensure these important healthcare products are safe, quality, and work well³⁴.

Definition of In Vitro Diagnostic Medical Devices

In vitro diagnostic (IVD) medical devices are key in healthcare. They help diagnose diseases, track treatment progress, and manage patient care. The EU’s In Vitro Diagnostic Medical Devices Directive (IVDD 98/79/EC) defines them as devices used to examine human body samples⁵. These devices give info on a person’s health, birth defects, or how well a treatment might work⁵.

IVD medical devices cover a wide range of products and uses. They include devices for testing blood, tissues, and other fluids to find diseases, check treatment progress, and screen for health issues⁶. The rules for these devices depend on their use and risk level. This ensures they are safe and meet quality standards⁷.

IVD Product Classification	Examples	Regulatory Oversight
Class I	General purpose reagents, analyte specific reagents	Subject to General Controls, may require 510(k) clearance
Class II	Pregnancy tests, blood glucose monitors	Subject to Special Controls, require 510(k) clearance
Class III	HIV diagnostic tests, genetic tests	Subject to Premarket Approval (PMA), highest level of oversight

The rules for IVD medical devices keep changing with healthcare advances. This ensures these important tools stay safe, effective, and meet patient and healthcare needs⁷.

Essential Requirements for In Vitro Diagnostic Medical Devices

The IVDD sets clear rules for in vitro diagnostic (IVD) medical devices. These rules help keep patients, users, and others safe⁸. They focus on safety, performance, design, and how the devices are made. This helps reduce risks and make sure IVD devices work well.

Safety and Performance Standards

IVD medical device makers must make sure their products keep patients and others safe⁹. They pick the right materials and control infections well. They also test the devices to check their safety and how well they work. The IVDD says these devices must meet certain safety and performance standards.

Design and Manufacturing Considerations

The IVDD also says IVD devices should be made to be safe and work well⁹. Makers need to think about the materials used and how the device will be used. They must follow quality control steps during production. Following these rules is key to making sure IVD devices are reliable and effective.

Requirement	Description
IVDD essential requirements	Comprehensive set of requirements for IVD medical devices, including safety, performance, design, and manufacturing considerations.
IVD safety standards	Manufacturers must ensure IVD devices are designed and produced to safeguard the health and safety of patients, users, and other individuals.
IVD design and manufacturing	Devices must be designed and manufactured to minimize risks and optimize effectiveness, with appropriate material selection, quality control, and other factors.

“The IVDD establishes essential requirements that IVD medical devices must meet to ensure a high level of health protection.”

Classification of In Vitro Diagnostic Medical Devices

The IVDD (In Vitro Diagnostic Medical Devices Directive) puts IVDs into two main groups based on their risk to public health¹⁰. Most IVDs are seen as low-risk and can hit the market without needing a Notified Body’s check¹¹. But, high-risk devices, like those checking blood and organ donations safety, need strict checks by a Notified Body¹⁰.

The MDCG backs a guide on classifying IVDs under Regulation (EU) 2017/746¹⁰. This guide explains how to classify, the tech used, and the types of samples for IVDs¹⁰.

IVD Risk Class	Examples
Class A (Low Risk)	Laboratory instruments, buffer solutions
Class B (Moderate Risk)	Pregnancy tests, cholesterol tests
Class C (High Risk)	Diagnostic tests for infectious agents
Class D (Highest Risk)	Life-threatening infectious disease tests

The IVDR sets four risk classes for IVDs: Class A (low risk), Class B (moderate risk), Class C (high risk), and Class D (highest risk)¹¹. Now, 80-90% of IVDs need a Notified Body check, unlike before when manufacturers self-certified¹¹.

IVD medical device classification

The IVDR has seven rules for classifying devices, like Rule One for Class D devices dealing with transmissible agents¹¹. Now, IVD makers, except for Class A non-sterile ones, must have a QMS and get yearly Notified Body audits, with ISO 13485 as the EU standard¹¹.

Regulation (EU) 2017/746 on IVDs replaced Directive 98/79/EC and starts on 26 May 2022, with grace periods for companies to adjust¹². It sorts IVDs into classes A, B, C, and D by their risk and purpose¹²¹⁰¹¹.

Conformity Assessment Procedures

The IVDD 98/79/EC outlines the conformity assessment rules for IVD medical devices in the European Economic Area¹³. To sell these devices, manufacturers must submit a declaration of conformity. This shows they meet safety and performance standards. They also need to pick the right assessment modules based on the device’s risk level¹³.

In some cases, a notified body reviews the manufacturer’s documents and might test the product¹³.

Manufacturer’s Role and Responsibilities

As an IVD manufacturer, you must set up a quality management system and analyze risks. You also need to prepare a detailed technical file to prove your device is safe and works well¹³. For less risky devices, you can do the assessment on your own¹³.

But, for more risky devices, a notified body must check your documents and sometimes test the product¹³.

IVD manufacturers must keep records, fix any issues, and tell authorities about problems. They also need to regularly check their products to make sure they still meet the rules¹³.

“Conformity assessment proves a device is safe, works well, and has its benefits and risks. This helps regulatory bodies make sure it meets the rules.”¹³

The type of IVD device affects how it’s assessed; more risky ones need stricter checks¹³. Manufacturers need to know the IVDD rules well and follow them carefully. This way, they can legally sell their products in the European Union¹³.

In vitro diagnostic medical devices directive

The IVDD 98/79/EC sets rules for in vitro diagnostic medical devices in the European Union¹⁴. It covers safety, performance, design, and manufacturing standards¹⁴. The directive also explains how manufacturers must prove their products are safe to sell in the EU, especially for high-risk devices¹⁴.

The IVDD ensures IVD devices are safe and work well, helping protect health in the EU¹⁴. It gives a full IVDD overview and IVDD requirements summary for makers to follow¹⁴.

Regulation (EU) 2017/746 took effect on 26 May 2022, replacing Directive 98/79/EC¹⁴.
Directive 98/79/EC was active until 25 May 2022¹⁴.
Commission Implementing Decision (EU) 2021/1195 on 19 July 2021 listed standards for IVD devices¹⁴.
Changes were made to Implementing Decision (EU) 2021/1195 in 2022, 2023, and 2024¹⁴.
The Commission shared a list of standards for IVD devices in the Official Journal of the European Union (OJ)¹⁴.
This list aims to help with finding standards and warns that it might not always be current¹⁴.

The IVDD makes sure IVD devices are safe and work right, keeping patients and users in the EU safe¹⁴. It creates a common set of rules, making it easier to move these important medical tools around the EU¹⁴.

“The IVDD is a key law that keeps IVD devices safe and effective, making sure they meet top standards.” – Expert Panel on IVD Regulation

Harmonized Standards and Common Technical Specifications

The EU’s In Vitro Diagnostic Medical Devices (IVDD) Directive promotes the use of IVD harmonized standards. These standards come from European groups like CEN, CENELEC, or ETSI¹⁵. They help with the design and making of IVD devices. This makes it easier for companies to follow EU laws¹⁵. The standards’ references are listed in the Official Journal of the European Union (OJEU)¹⁵.

The IVDD also uses IVDD common technical specifications for certain devices. These are for checking blood and organ safety. They help make rules the same across the EU, making IVD devices move freely and keeping patients safe¹⁶.

But, making standards the same under the EU’s new Medical Device and In Vitro Diagnostic Medical Device Regulations has been slow¹⁷. There’s a big list of “candidate” standards waiting to be agreed upon. This can be a problem for companies trying to follow the rules¹⁷. Still, countries like Switzerland follow the EU’s rules closely, keeping standards the same¹⁷.

To keep up with changes in IVD harmonized standards and IVDD common technical specifications, you can follow the EUR-Lex website or subscribe to their RSS feed¹⁵.

Harmonized Standards Coverage	Percentage
Chemicals	15%
Construction	12%
Consumer Protection	10%
Energy Efficiency	8%
Healthcare Engineering	18%
Measuring Technology	11%
Mechanical Engineering	9%
Services	7%
Sustainability	10%

“Harmonised standards in the EU are developed by recognized European Standards Organisations such as CEN, CENELEC, or ETSI.”¹⁵

Labeling and Packaging Requirements

The European Union’s In Vitro Diagnostic Medical Devices (IVDD) Directive 98/79/EC sets clear rules for IVD product labels and packaging¹⁸. Labels must show the maker’s details, what the device is for, and any safety tips¹⁸. They also need to list when the device is no longer safe to use¹⁸.

IVD packaging must keep the product safe during storage and transport¹⁹. It’s important to think about labeling and packaging from the start to the end of the product’s life¹⁹. Companies often give advice on how to safely and eco-friendly dispose of packaging¹⁹.

Information to be Provided by the Manufacturer

According to the IVDD, labels and instructions must be clear and easy to read¹⁸. They should be in the local language of the country where sold, and for self-testing, in paper form¹⁸. For professional use, they can be on paper or digital formats like CD-ROM or the internet¹⁸.

Companies must also follow rules for IFUs on websites and update labels and IFUs when needed¹⁸. Authorities can ask for proof that labels and IFUs match¹⁸.

In places like the Netherlands, labels and instructions for the public must be in Dutch²⁰. But for professional use, they can be in English²⁰. The company’s address must be on the label too²⁰.

“Labeling and packaging are key to making sure medical and IVD devices work safely and effectively.”¹⁹

Requirement	Description
Label Information	Manufacturer’s name and address Device’s intended purpose Warnings and precautions Expiration date
Instructions for Use (IFU)	Provided in official language(s) of the country Paper format for devices intended for self-testing Paper or non-paper format for devices intended for professional use Revisions clearly indicated on the device label
Packaging	Designed to protect the device and maintain safety/performance Information on safe and environmentally responsible disposal

The IVDD and other EU rules like the MDR 2017/745 and IVDR 2017/746 set the standards for IVD labels and packaging in Europe¹⁹. Companies must follow these rules to make sure their products are safe and work well¹⁹.

Post-Market Surveillance and Vigilance

The EU’s Directive for In Vitro Diagnostic Medical Devices makes sure manufacturers keep an eye on their devices after they hit the market²¹. They must tell the authorities about serious incidents or deaths linked to their devices²¹. This keeps everyone safe and makes sure devices are still safe to use.

Under the IVDD, it’s up to manufacturers to gather and check data from their devices²². They have to send in Safety Update Reports for certain devices every year²². It’s key to report any issues with devices to keep people safe, and not doing so can lead to legal trouble²².

The IVDR also has rules for keeping an eye on devices after they’re sold, similar to the MDR²². These rules are strict and have clear deadlines for reporting²².

Role	Percentage of Attendees
Regulatory Affairs Managers	25%
Quality Managers	20%
Person in Charge of Regulatory Compliance	15%
Internal and External Auditors	15%
Importers	10%
Distributors	15%

A 1-day training on IVDD post-market surveillance and vigilance is set for August 08, 2024²³. It will cover the rules, how to follow the new IVDR and MDR, and the role of the Notified Body²³. The training includes presentations, hands-on sessions, and a course review²³.

“The post-market surveillance and post-market follow-up requirements in both the MDR and IVDR regulations are robust and initiative-driven, with consistent deadlines and timelines for reporting.”

In summary, the IVDD post-market surveillance and IVDD vigilance system are key to keeping in vitro diagnostic medical devices safe and working right. Manufacturers must follow strict rules for reporting and monitoring, working with authorities and notified bodies to handle risks and keep everyone safe²².

Conclusion

The IVDD 98/79/EC has been key in setting rules for in vitro diagnostic medical devices in the European Union. This directive helps ensure IVD products move freely while keeping them safe and effective. It protects patients, users, and others by setting high standards²⁴.

Manufacturers must follow the IVDD’s rules, like setting up quality systems and getting CE marking, to sell IVD products in the EU²⁴. This approach to regulating IVDs is a model for the world, showing the value of IVDD compliance, IVD regulatory overview, and EU medical device regulations²⁴.

As the EU moves to the new In Vitro Diagnostic Regulation (IVDR, makers will face tougher rules and more oversight from notified bodies²⁵. This change shows how the IVD industry is always evolving. It highlights the need for constant attention and change to keep patients safe and products on the market²⁵.

FAQ

What is the IVDD 98/79/EC?

The IVDD 98/79/EC is a European Union directive. It sets rules for in vitro diagnostic medical devices. It ensures these devices can move freely within the EU while keeping health protection high.

What are the objectives of the IVDD?

The IVDD aims to make sure IVD devices can move freely in the EU. It also keeps patients, users, and others safe. It does this by making sure all EU countries have the same rules for IVD devices.

How does the IVDD define in vitro diagnostic medical devices?

The IVDD says IVD devices are things like tests and tools used on human samples. They help find out about health issues, check if organs are safe for transplant, and more.

What are the essential requirements for IVD medical devices under the IVDD?

IVD devices must meet certain standards to be safe and work well. They need to be designed and made to protect people from harm.

How are IVD medical devices classified under the IVDD?

The IVDD puts IVD devices into two groups based on their risk level. Most are low-risk and can be sold easily. But high-risk ones, like those for checking blood safety, need more checks.

What are the conformity assessment procedures for IVD medical devices under the IVDD?

To sell IVD devices in the EU, makers must follow certain steps. Low-risk devices can be checked by the maker alone. But high-risk ones need a notified body to check them.

What is the role of harmonized standards and common technical specifications in the IVDD?

Harmonized standards help show IVD devices meet EU rules. The IVDD also lets for common tech specs for certain devices. This makes things easier for everyone.

What are the labeling and packaging requirements for IVD medical devices under the IVDD?

IVD devices must have clear labels and safe packaging. Labels need to show the maker’s info and what the device does. Packaging keeps the device safe during storage and transport.

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

After selling, IVD devices are watched closely to see how they work and stay safe. If there are serious issues, the maker must tell the authorities. This helps keep devices safe for everyone.