Europe wants to reboot its medical device regulations.
On September 26, 2012, the Eurpean Commission released a proposal for future regulation of medical devices. Within the package, according to an analysis from the BSI Group, the current three Directives on active implantable medical devices (AIMD), medical devices (MDD) as well as in vitro diagnostic medical devices (IVDD) are replaced by two Regulations, one covering all medical devices, the other covering IVDDs.
Uniformity, Predictability and Transparency
These new rules, states the BSI analysis, are proposed for a number of reasons, including the need to bring legislation in line with the pace of technological and scientific progress over the last 20 years. In addition the proposed changes bring uniformity as current Directives lead to different interpretation and implementation in the various EU (European Union) member states and consequently to different levels of patient and public health protection in the EU. The new Regulations also aim to improve traceability, and transparency.
The revision was initiated in 2008 before the recent silicone breast implant scandal and problems uncovered in registries about certain metal-on-metal hip joint replacements. “Lessons learned have been used to strengthen the system, and ensure it is ready to face the future, ” said the BSI statement.
The proposal includes more detail on medical devices and on IVDDs, it also encompasses the possibility of short-term further revision by referring to amending and implementing acts that can be added in the future.
Stronger Supervision
Independent assessment agencies will be given greater powers to monitor device manufacturers, including unannounced factory inspections and regular product testing, while EU governments will be obliged to improve their supervision of the agencies.
Better product traceability systems will also be introduced so that people can be alerted more rapidly to safety concerns surrounding a particular device.
The European market for medical devices is estimated at $123 billion in 2009.
The legislation must be jointly approved by EU governments and lawmakers. That could take up to two years.
Unhappy Manufacturers and Patient Advocates
Eucomed, which represents about 22, 500 medical technology companies in Europe, reportedly said it was unhappy with the proposal for the new scrutiny panel procedure, which it said would “hamper innovation” whilst providing no extra safety nets for patients.
Equally unhappy was the European Consumer Organisation (BEUC), which reportedly argued that the plans fall short of increasing quality and safety standards and said medical device regulations should be beefed up to levels similar to those required for pharmaceuticals.
Below, courtesy of the BSI Group, are the main changes proposed for medical devices:
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The MDD will become a Regulation rather than a Directive
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Wider and clearer scope of EU legislation, extended to include implants for aesthetic purposes, and human tissue derived devices
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Stronger supervision of notified bodies by national authorities
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More powers for notified bodies vis-à-vis the manufacturers, to ensure thorough testing and regular checks, including unannounced factory inspections at manufacturing sites
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Clearer rights and responsibilities for manufacturers, authorised representatives, importers and distributors, including in the case of diagnostic services and internet sales
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Extended database on medical devices (Eudamed), providing comprehensive and public information on products available on the EU market
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Better traceability of devices throughout the supply chain, enabling a swift and effective response to safety concerns (e.g. recalls)
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Reinforced rules for clinical investigations on devices and the required clinical data for the pre-market and the continuous post-market assessment of medical devices, including in vitro diagnostic medical devices
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Adaptation of the general health and safety requirements, including labelling provisions, to the technological and scientific progress
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A limited number of reclassifications (orthopaedic implant, aphaeresis equipment)
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Creation of a Medical Device Coordination Group (MDCG) composed of members representing national competent authorities in the field of medical devices to ensure better coordination between Member States, with the Commission providing the necessary scientific, technical and logistic support
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The Notified Body will have to inform the MDCG of all new high risk applications and submit a summary of safety and performance, the MDCG can request additional information within 15 days and additional information within 90 days, this does not apply to changes to existing products
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Each manufacturer and authorised representative will require a Qualified Person with five years of Medical Device regulatory experience to be responsible for the conformity of batches to be released, maintenance for the technical documentation and declaration of conformity plus vigilance reporting
