Implementation of regulations


Implementing the new IVD and Medical Devices Regulations - our position on:

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Implementation of regulations

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.
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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.