Regulations


How are medical technologies regulated today?

Medical technologies are tightly regulated in the European Union. Before a medical technology can be legally placed on the EU market, a manufacturer must comply with the requirements of all applicable EU legislation and affix a CE mark to their device. There is EU sectoral legislation which specifically regulates the medical devices (MD) and In vitro diagnostic (IVD) medical devices sectors; these govern the safety and performance of devices across their lifetime. 

During a set of transition periods manufacturers may choose to continue to comply with the applicable Directive or they may choose early compliance to the applicable Regulation: 

  • During a 3 year transition period until 26 May 2020, medical devices can continue to be regulated under the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD), or Manufacturers can choose to comply with the Medical Devices Regulation (MDR). From 26 May 2020, medical devices can only be placed on the market under the MDR (with certain exceptions given under the transitional provisions). 
  • During a 5 year transition period until 26 May 2022, IVDs can continue to be regulated under the In Vitro Diagnostic Medical Devices Directive (IVDD) or manufacturers can choose to comply with the In Vitro Diagnostic Medical Devices Regulation (IVDR). From 26 May 2022, IVDs can only be placed on the market under the IVDR (with certain exceptions given under the transitional provisions). 

The transition periods are essential for ensuring a continued supply of CE-marked medical technologies to European and international markets. However most products may not be able to comply with the Regulations until late in the transition periods: 

  • The European Commission needs to publish many implementing acts, which are laws needed to implement both Regulations. These laws will be gradually published during the transition periods.
  • Notified bodies may only be in place later during the transition periods. Notified bodies are the auditing bodies which certify products and quality management systems – without them most manufacturers cannot choose compliance to the new Regulation. 
  • A new electronic platform called ‘Eudamed’ is only expected to be operational just before 2020. Compliance to both Regulations depends on Eudamed: ~ 75 articles and/or paragraphs in each Regulation are related to this new electronic and integrated platform.

Regardless if a product is CE-marked under the Directives or the Regulations, customers will continue to receive medical technologies with a high level of quality, safety and performance; the hallmark of the EU CE-marking system.

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.
 
Regulations

MDD Fact sheets

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

Comments on Council Approach on proposed regulation on In Vitro Diagnostic Medical Devices

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.
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.