Revision of Medical Device Directives

 

current status:  Medical Devices & IVD Devices

 

http://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework/revision_en

 

 

 

The new Regulations on medical devices

On 5 April 2017, 2 new Regulations on medical devices (a Regulation on medical devices and a Regulation on in-vitro diagnostic medical devices) were adopted. These replace the existing Directives.

The new rules will only apply after a transitional period. Namely, 3 years after entry into force for the Regulation on medical devices (spring 2020) and 5 years after entry into force (spring 2022) for the Regulation on in vitro diagnostic medical devices.

The Commission welcomes the adoption of its proposal for 2 Regulations on medical devices which establish a modernised and more robust EU legislative framework to ensure better protection of public health and patient safety.

The new Regulations in a nutshell

The new Regulations contain a series of extremely important improvements to modernise the current system. Among them are:

  • stricter ex-ante control for high-risk devices via a new pre-market scrutiny mechanism with the involvement of a pool of experts at EU level;
  • the reinforcement of the criteria for designation and processes for oversight of Notified Bodies;
  • the inclusion of certain aesthetic devices which present the same characteristics and risk profile as analogous medical devices under the scope of these Regulations;
  • the introduction of a new risk classification system for in vitro diagnostic medical devices in line with international guidance;
  • improved transparency through the establishment of a comprehensive EU database on medical devices and of a device traceability system based on Unique Device Identification;
  • the introduction of an “implant card” containing information about implanted medical devices for a patient;
  • the reinforcement of the rules on clinical evidence, including an EU-wide coordinated procedure for authorisation of multi-centre clinical investigations
  • the strengthening of post-market surveillance requirements for manufacturers;
  • improved coordination mechanisms between EU countries in the fields of vigilance and market surveillance. 

More information is available in this presentation that contains general information on key changes contained in the Regulations and transitional periods.

The final adopted texts are expected to be published in the Official journal early May. In the meantime the final texts of the Regulations as voted by the Council and the European Parliament are available here:

The main reasons behind this change

Problems with diverging interpretation of the current Directives as well as some incidents with breast implants and metal hips highlighted the weaknesses of the current legal system and damaged the confidence of patients, consumers and healthcare professionals in the safety of medical devices. Such problems should not occur again and the safety of all medical devices available in the EU has to be strengthened. Moreover, revision of the legislation was necessary to consolidate the role of the EU as a global leader in the sector over the long-term and to take into account all technological and scientific developments in the sector.

The new regulations will ensure:

  • a consistently high level of health and safety protection for EU citizens using these products
  • the free and fair trade of the products throughout the EU
  • that EU legislation is adapted to the significant technological and scientific progress occurring in this sector over the last 20 years.

 

 

Previous action: Regulation proposals of the European Commission

In 2012, the Commission adopted a package of measures on innovation in health. The package consisted of a Communication and two regulation proposals to revise existing legislation on general medical devices and in vitro diagnostic medical devices.

The revisions affected all kinds of medical devices including in vitro diagnostic medical devices, from home-use items like sticking plasters, pregnancy tests and contact lenses, to X-ray machines, pacemakers, breast implants, hip replacements and HIV blood tests.

Objective

The aim of the revisions was to ensure:

  • a consistently high level of health and safety protection for EU citizens using these products
  • the free and fair trade of the products throughout the EU
  • that EU legislation is adapted to the significant technological and scientific progress in this sector over the last 20 years.

Revisions included the extending of the scope for legislation; better supervision of independent assessment bodies; clear rights for manufacturers/distributors; and stronger requirements for medical evidence.

More information

Impact assessment

The Commission proposals are accompanied by an impact assessment on the revision of the regulatory framework for medical devices.

Theis impact assessment:

  • describes the problems encountered under the existing legislation
  • justifies the need and the objectives of the Commission initiative
  • compares the different policy options and their impact on the medical devices sector.

More information

EU legislative procedure

The aforementioned proposals have been submitted to the European Parliament and the Council. In order to become EU law, the Parliament and the Council need to adopt the texts by ordinary legislative procedure.

See below for more detailed information on the revisions process at Parliament/Council level:

More information

Preparation of the European Commission’s proposals

After the last amendment of Council Directives 90/385/EEC and 93/42/EEC by Directive 2007/47/EC (see below), the Commission considered a fundamental revision of the regulatory framework for medical devices necessary to ensure:

  • a high level of human health and safety
  • the smooth functioning of the internal market
  • it meets the growing expectations of European citizens.

At the same time, the revisions sought to preserve the innovation-friendly approach of the regulation.

Public consultation

In 2008, the Commission published a public consultation documentpdf Choose translations of the previous link (84 kB) to seek stakeholder views on the revision of the legal framework for medical devices ('recast'). The 200 responses received are contained in a summary report (Appendix 1) and the individual responses are also available.

To complement the first consultation, in June 2010, the Commission launched a public consultation on technical aspects of in vitro diagnostic (IVD) medical devices., related to the revision of Directive 98/79/EC

Previous revision: Directive 2007/47/EC

In 2005, the Commission proposed amendments to Council Directives 90/385/EEC and 93/42/EEC, which led to the adoption of Directive 2007/47/EC of the European Parliament and of the Council in September 2007.

 

Related documents

 

 

Source:

http://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework/revision/index_en.htm

 

 

See also:  IPEX - The platform for EU Interparliamentary Exchange

Consulting   & Interim Management

Quality Management & Regulatory Affairs  Medical Devices & Combination products

 

Since 1994, effective Strategic & Operative experience in Quality Management & Regulatory Affairs for Medical Devices industry, within the fields of Ophthalmology, Neuro-stimulation, Vascular Intervention, Cardiology, Heart Surgery, Orthopedics, Dental Care, Modern Wound Care, Regional Anesthesia, Minimal Invasive Surgery, Navigated Robotic Surgery, CT & NMR digital Imaging (3D), and in vitro Diagnostics.

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Product & Production-process Risk Management (Risk Analysis & Risk Control), including Additive Manufacturing. 

Clinical Evaluation, Organization of global multicenter Clinical Studies.

Audits of Production Processes & Suppliers.

Medical Device Reporting to Competent Authorities (e.g. BfArM, FDA).

Corrective And Preventive Action (CAPA) / Non-Conformity (NC) / corrective Project.

On site Support in Notified Body audits, and FDA inspections.

Effective management leading to a multitude of marketing approvals in the EU, Americas (FDA), & Asia, including Reimbursement schemes.

 

 

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