In Vitro Diagnostic Medical Devices Directive

Currently the safety and performance of in vitro diagnostic devices are regulated in the EU by the 1998 In Vitro Diagnostic Medical Devices Directive (IVDD). This sets a framework for manufacturers and for authorised representatives who seek to place IVD products on EU market.

Current legislation

The current In Vitro Diagnostic Medical Devices Directive (IVDD) aims to ensure that IVD devices comply with stringent standards for quality and safety, and produce reliable data to be used for diagnostic purposes.

The IVDD lays down a series of essential requirements to ensure the efficacy, quality and safety of products. It requires that the safety and health of patients, users, and any third party must not be endangered by proper use of the product, and that any possible product risk, compared with the associated benefit, is acceptable.

The principle of integrated safety applies, which means risk avoidance and risk minimisation in the design and manufacture of the product, protective measures against residual risks, and appropriate information of users. The generally acknowledged state of the art must be applied.

Importantly, the IVDD recognises that IVDs have specific, unique characteristics that demand specific rules and regulations.

Revision of the IVDD

Although the original goals of ensuring the safety of devices and the functioning of the internal market have largely been met by the IVD directive, the current framework is looking more and more outdated.

The existing EU legislation, dating back to the 1990s, has not kept pace with the enormous technological and scientific progress in the past 20 years and like every regulatory regime dealing with innovative products it needs regular revision. The revision also aims to improve international regulatory convergence by adopting principles set by the Global Harmonization Task Force (GHTF).

The proposed revision on IVDs will be in the form of a regulation, and so will have a direct effect in EU member states.

Although some elements will remain the same, the forthcoming regulation promises widespread changes to the IVD landscape in Europe. It will:

  • introduce new classification rules that divide the broad range of IVD medical devices into different risk classes,
  • tighten up conformity assessment procedures and introduce new requirements for notified bodies,
  • reinforce rules for clinical evidence requirements for IVD devices. There would be additional requirements, especially for new devices, to help make the work of laboratories and healthcare professionals easier when selecting new tests,
  • introduce more requirements for clinical data for the pre-market and the continuous post-market assessment of IVD devices. This includes further development of the European databank on medical devices (Eudamed),
  • introduce new labelling requirements, such as the development of a unique device identification (UDI) system.

MedTech Europe’s position

IVDs are distinct from other medical technologies in many ways, but perhaps the most important difference is that they never come into direct contact with the patient. Instead, they provide information on a person’s health through the analysis of samples.

Given that the EU legislation aims to ensure the safety of the technology for the patient, the proposed regulation should continue to reflect this difference: unlike other devices or pharmaceuticals, the risk is in the nature of the information being collected by the IVD, not the direct effect of the intervention on the patient.

If these differences are not taken into account, IVD device manufacturers will face an inappropriate regulatory burden, which will inevitably slow innovation and patient access to potential life-saving technology.

In Vitro Diagnostic Medical Devices Directive

In Vitro Diagnostic Medical Devices Directive

EDMA, the voice of the in vitro diagnostic manufacturers in Europe, welcomes the progress in the development of an EU Regulation on In Vitro Diagnostics (IVD), which intends to strengthen the current approval system for in-vitro diagnostics. This regulation will introduce substantial changes to the existing legislation, first introduced in 1998. The Council’s partial general approach of June 2015 still falls short, and requires improvement to fulfil the overarching objective of creating a new specific regulation for in vitro diagnostic medical devices.
Read article
Position paper

The use of the single registration number - Proposal for an IVD Regulation

In their General Approach (Art. 23a), Council has proposed the use of a ‘Single Registration Number’ which would be assigned to each manufacturer or their authorised representative. Council envisions that the Single Registration Number (SRN) would be included in these areas: the device label, the EUDAMED database, the Unique Device Identification (UDI) data base, the summary of safety and performance, the declaration of conformity and certificates issued by notified bodies.
Position paper

Requirement for a periodic safety update report - Proposal for an IVD Regulation

In their General Approach (Art. 58c), Council proposed a brand new requirement in the field of vigilance reporting: a periodic safety update report (PSUR) will need to be completed and maintained by the manufacturer for each device or category/group of devices. This report will provide conclusions from analyses by the manufacturer of post-market surveillance data.
Position paper

Requirements for point of care testing systems - Proposal for an IVD Regulation

In their General Approach (Art. 40), the Council has proposed general safety and performance requirements for usability that are specific to self-testing and to point-of-care devices. In order to control for compliance with all the general safety and performance requirements including usability, they have proposed a full technical documentation assessment for each individual self-testing and point-of-care device.
Position paper

Recommendations by an EU-wide cross-industry initiative for better regulation in chemicals management

EDMA and Eucomed are signatories to the Cross Industry Initiative (CII) that developed a concrete set of proposals aimed at achieving better regulation in chemicals management. The streamlined position paper addresses in particular the situation when potential risks of a substance are limited to the workplace and can be more effectively addressed by workplace-specific legislation. The position paper explains how to implement and enforce the most effective risk management options that are tailored to tackle a specific risk.
Position paper

Concept of an IVD Kit

The concept of an in vitro diagnostic kit has become increasingly relevant in discussions related to the revision of the IVD Directive; therefore EDMA aims to set a common ground for the perception and terminology of such an IVD medical device.
Position paper

Proposed regulation in IVD devices - Clinical evidence

The introduction of clinical evidence is an essential component of the new IVD regulation and will have a crucial impact on the IVD sector when implementing this regulation. Clinical evidence requirements should be adapted to the specific needs of IVDs, and be feasible and realistic to implement for regulators and manufacturers alike.
Position paper

Revision of Directive 98/79/ECON In Vitro Diagnostic Medical Devices

EDMA, the voice of the in vitro diagnostic manufacturers in Europe, welcomes the revision of the EU In Vitro Diagnostics (IVD) Directive and the intention to strengthen the current approval system for in-vitro diagnostics for the sake of patient safety, whilst still guaranteeing a competitive and innovative environment for manufacturers.