Worldwide Medical Device Regulatory Updates

European Union member states should take immediate steps to tighten regulatory controls over medical devices and technologies in the wake of revelations that French breast implant manufacturer Poly Implant Prothèse Company (PIP) used non-medical-grade silicone in its products.

European Health and Consumer Policy Commissioner John Dalli last week urged coordinated efforts at national levels to ensure full implementation and enforcement of existing medical device legislation to guarantee safety and improve patient confidence in the EU regulatory system.

Dalli’s specific recommendations include verification of notified body designations to evaluate whether these entities are truly designated only for assessment of medical devices and technologies, as well as making sure that Notified Bodies fully leverage their authority laid out in conformity assessments, including their power to conduct unannounced inspections.

Dalli also recommends reinforcing market surveillance processes by national regulators, especially regarding spot checks of some devices. Vigilance system functions must also be improved via granting Notified Bodies systemic access to adverse event reports and urging health care providers and patients to report adverse events to authorities.

In addition, Dalli suggests supporting development of tools to enhance traceability of medical devices in the EU, and tools such as the Unique Device Identification system for monitoring long-term safety and performance of devices.

Finally, results of a stress test being conducted to address any weaknesses in the EU system illustrated by the PIP incident will impact ongoing work to revise the EU’s Medical Devices legislation, according to the European Commission’s press release.

European medical device industry trade association Eucomed has officially expressed support for Dalli’s recommendations, and has added a few of its own as well: utilizing “only the best” Notified Bodies, developing a single approach to vigilance and market surveillance, and strengthening harmonized standards used in the EU. Furthermore, Eucomed recommends more consistent guideline implementation, added transparency and a more integrated regulatory approach.

Whether the PIP controversy significantly impacts how Europe’s Medical Device Directives are revised remains to be seen. Reactions among member states so far do not bode necessarily well for a more unified approach, however; French authorities, for example, have initially taken a much more aggressive approach to the problem than their British counterparts. 

The European Commission has published draft regulation covering electronic instructions for use in the European Union that would affect both device medical device manufacturers and notified bodies.

Although any finalization date for the regulation remains unknown, The EU Regulatory Committee on Medical Devices is expected to consider the draft document in late September, according to BSI.

The draft regulation specifies which medical devices qualify for electronic instructions for use in lieu of manual instructions:

• Active implantable medical devices and accessories covered by Directive 90/385/EEC
• Implantable devices and accessories as well as fixed installed devices covered by Directive 93/42/EEC
• Medical devices and accessories fitted with built-in capabilities to display instructions for use and covered by Directives 90/385/EEC and 93/42/EEC
• Stand-alone software covered by Directive 93/42/EEC

Furthermore, manufacturers of the devices listed above may issue electronic instructions for use only if those devices are intended for use only by professionals, the regulation stipulates.

Manufacturers of qualifying medical devices must also conduct risk assessments to account for the knowledge and experience of intended professional users of their products, the environment in which their products will be used, as well as users’ knowledge and experience regarding any hardware and software required to display electronic instructions for use. Manufacturers would also have to assess electronic data safeguards as well as hardware and software safety and backup mechanisms. Risk assessments would also have to be updated based on post-market experience and data.

Providing electronic instructions for use would also be contingent upon several conditions, including:

• Risk assessments must show that electronic instructions for use maintain or improve the device’s safety level
• Electronic instructions for use must be made available in all EU member states where the device is sold or used
• Instructions for use in paper format must be provided to users upon request
• Information regarding foreseeable medical emergency situations
• Manufacturers must provide verification and validation evidence that electronic instructions for use are designed and function properly

With the exception of Class I medical devices defined in Annex IX of Directive 93/42/EEC, the draft regulation would obligate notified bodies to review manufacturers’ compliance with all requirements during conformity assessments using sampling methods appropriate for particular devices’ class and complexity.

European medical device industry trade group Eucomed has issued four major recommendations to the European Commission regarding easing regulatory requirements for small and medium-sized enterprises (SMEs) in order to foster innovation.

Eucomed has published a position paper, European Health and SMEs: Big Challenges, Small & Medium Sized Solutions, following a survey the group conducted over the course of 2010 of 12 European national medical technology industry associations to pinpoint major regulatory barriers to SMEs. Based on those survey findings, Eucomed has made four broad recommendations to EU regulators that the group argues will reduce unnecessary compliance requirements for smaller-tier medical device manufacturers.

First, Eucomed suggests a coordinated and transparent market surveillance program able to target specific product groups for both domestic and imported devices.

Second, the trade group argues for faster commercialization of “novel technologies” in order to expedite patient access to cutting-edge treatment and products.

Third, easier application processes for research and design funding programs should be established so that SMEs can more effectively access those funds.

Fourth, Eucomed urges broader information sharing among member state competent authorities pertaining to market access models and distribution channels to increase the overall size of the European medical device market.

On a related note, the trade association has suggested more transparent and predictable purchasing processes across the EU to clear up persistent questions about reimbursement and procurement; Eucomed also recommends scaled down Health Technology Assessment procedures be made available to SMEs with limited resources. (Eucomed plans to issue a separate document more fully discussing these two suggestions at a later, unspecified date.)

Furthermore, Eucomed has requested that the European Commission conduct a comprehensive survey of SMEs in the medical technology industry in order to more fully identify these firms’ operational needs and characteristics.

The European Commission has issued new guidelines for how entities conducting clinical trials should report serious adverse events to appropriate national competent authorities (NCAs).

The new release, MEDDEV 2.7/3, covers pre-market clinical investigations for non-CE marked medical devices as well as for CE marked devices tested for indications beyond which CE marking was ascribed. The guidelines were issued to address requirements of Directive 90/385/EEC’s Annex 7 and Directive 93/42/EEc’s Annex X stating, “All serious adverse events must be fully recorded and immediately notified to all competent authorities of the Member States in which the clinical investigation is being performed.”

MEDDEV 2.7/3 identifies the following events as reportable according to the aforementioned Directives:

• Any serious adverse event
• Any Investigational Medical Device Deficiency that could have led to a serious adverse event if appropriate action had not been taken, no intervening action had been taken or if “circumstances had been less fortunate”
• New findings related to previously reported events

Reporting responsibilities fall to clinical investigation sponsors, according to the new guidelines; appropriate adverse events should be reported to all NCAs in whose territories those clinical investigations take place.

In terms of timelines, sponsors must report serious adverse events entailing risk of death, injury or illness to NCAs immediately but no later than two calendar days following awareness of the event. For all other adverse or other events identified in MEDDEV 2.7/3, sponsors have up to seven calendar days to report to their NCAs. Furthermore, the guidelines suggest sponsors deploy systems to enable their clinical investigators to report relevant events to sponsors within three calendar days of their occurrence.

A copy of the reporting form template sponsors should use for submission of events to NCAs is available in the MEDDEV 2.7/3 release.