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 contain a series of extremely important improvements to modernise the current system. Among them are:
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:
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:
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.
The aim of the revisions was to ensure:
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.
The Commission proposals are accompanied by an impact assessment on the revision of the regulatory framework for medical devices.
Theis impact assessment:
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:
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:
At the same time, the revisions sought to preserve the innovation-friendly approach of the regulation.
In 2008, the Commission published a public consultation document (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
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.
See also: IPEX - The platform for EU Interparliamentary Exchange
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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