Worldwide Medical Device Regulatory Updates

As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That\'s why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you. No fluff, just straight to the point. We hope you\'ll enjoy the content.

Tighter EU Regulatory Controls Proposed following PIP Controversy

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.

Markets: EuropeTags: EC, EU, european commission, European Union, MDD, medical device, Medical Device Directives, Medical Devices Directive, PIP

Author: Stewart EisenhartDate: February 13, 2012

Eucomed Proposed EU Regulatory Fixes

European medical technology trade association Eucomed has issued a new position paper advocating six major changes to how the European Union regulates medical devices.

First, Eucomed argues for tighter control and monitoring of Notified Bodies across the EU. Precise and mandatory Notified Body designation requirements, EU-wide accreditation standards for Notified Bodies, and better Competent Authority control over Notified Bodies are prescribed, as well as joint auditing of Notified Bodies by both Competent Authorities and the European Commission.

Second, a single European approach to vigilance and surveillance should be established in order to foster a more uniform level of health protection across member states. Eucomed recommends a more well-defined legal framework for handling vigilance as well as a centralized reporting and surveillance infrastructure used by all EU member states for exchanging device information.

Third, all EU Competent Authorities should adhere more closely to harmonized standards, according to Eucomed, and participate more directly in the development of such standards in order to address mounting implementation issues in European markets.

Consistent implementation of guidelines, Eucomed’s fourth recommendation, entails revising existing procedures for developing guidelines in order to commit member states to uniformly put them in place. In addition, the European Commission’s Medical Device Expert Group should be upgraded from a voluntary to a formal advisory committee in order to establish and manage a more consistent guideline development process.

Fifth, European regulators should increase transparency regarding the Medical Devices Directives’ confidentiality requirements. Eucomed argues that such lack of transparency has undermined public trust in the EU regulatory system and CE marking process. This issue should be remedied by setting up a central EU database at least partially available to the public; the database should include information on devices available on the European market, registration of economic operators, vigilance and market surveillance data, and clinical investigations.

Finally, better coordination and management among European regulators is necessary in order to ensure uniform application of requirements across all member states. To achieve this goal, Eucomed suggests the following steps:

Auditing Notified Bodies for quality
Coordination of vigilance reporting systems and practices
More “horizon scanning” to deal with potential EU health challenges
Providing expert policy advice regarding medical technology to drive evidence-based decisions and legislation among regulators
Providing sound scientific advice to member states and European Commission personnel

Markets: EuropeTags: CE Mark, CE Marking, competent authorities, EU, Eucomed, european commission, MDD, Medical Devices Directive, notified bodies

Author: Stewart EisenhartDate: November 29, 2011

Eleven Notified Bodies Sign On to Code of Conduct

A voluntary code of conduct for European Notified Bodies appears to be gaining traction following the document’s publishing in early 2011.

Medtechinsider.com reports that eleven Notified Bodies have now signed the code of conduct ahead of a highly anticipated recast of the European Medical Devices Directive.

As we reported last May, the “NB5”—Notified Bodies BSI, TÜV Rheinland, TÜV SÜD, LNE-GMED and DEKRA/KEMA—plan on issuing a second draft of the code of conduct next month to address issues such as the IVD Directive and Conformity Assessments stipulated by MDD Annex III and AIMD Annex 3 (Type Examination) that are not included in the current iteration of the document. (These issues were not addressed in the first version of the code of conduct.)

Markets: EuropeTags: code of conduct for notified bodies, EU, MDD, Notified Body

Author: Stewart EisenhartDate: September 28, 2011

BVMed Annual Report: Healthy Returns, but Stronger Regulatory Support for Innovation Needed

In its latest annual report, German medical device industry trade group BVMed (Bundesverband Medezintechnologie) stakes out the group’s positions on German health policy, financing issues and medical device legislation, and also provides results of BVMed’s annual membership survey.

According to the survey, the German medical technology sector saw 5.5% sales growth in 2010, and 80% of respondents expect higher sales rates this year; profits will be challenged, on the other hand, by more expensive raw material costs and higher rates of outstanding debt.

In light of European economic challenges as well as increasing prices for raw materials, BVMed members expressed tempered optimism regarding 2011 results—48% of firms expect better returns this year, while only 17% anticipate lower returns.

Although respondents generally rated Germany highly as a medical device market, they also identified political and financial issues they believed should be improved in order to boost efficiencies in their view. To wit, 60% of firms cited reduced bureaucracy and faster decision-making processes as their top concern, and less than a quarter of respondents expressed satisfaction with the current German reimbursement system.

BVMed also used its annual report lays out positions the organization argues are necessary to better support innovative medical technologies in Germany. Among the group’s suggestions:

Formation and proper funding of an “innovation pool” to support independent assessment of medical devices’ benefits
Allowance for greater industry participation in the deliberations of the Joint Federal Committee overseeing Germany’s health care system
Expansion of innovation-friendly practices applied to the German inpatient sector to the outpatient sector as well
Keeping the Medical Devices Directive’s “New Approach” to regulating medical devices in place as the EU considers its MDD Recast

Give the size of the German medical device market—as well as the degree of influence Germany wields within the EU—how successfully BVMed pursues its goals will no doubt shape relationships between regulators and industry across Europe.

Markets: EuropeTags: BVMed, European Union, germany, MDD, medical device, Medical Devices Directive

Author: Stewart EisenhartDate: April 18, 2011