Medical Device Blog – QA & Regulatory Updates from Emergo Group

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

European Med-Tech Trade Groups Join Forces

European medical technology association Eucomed and the European Diagnostic Manufacturers Association (EDMA) are forming a single industry trade federation to more effectively lobby on behalf of their medical device and IVD manufacturing members.

The associations will name a joint chief executive to oversee activities and develop organizational strategies; however, Eucomed and EDMA will continue to operate as separate legal entities. Furthermore, the new joint federation is open to membership for other European industry trade groups, as well.

A top priority in the short term for the federation will be cooperating with EU policymakers hammering out a new regulatory framework for medical devices.

Markets: EuropeTags: edma, EU, Eucomed, Europe, European Union, IVD, medical device

Author: Stewart EisenhartDate: January 18, 2012

Drug and Medical Device Modernization Law Nearing Adoption in France

Two versions of a draft law amending regulations of pharmaceutical and medical technology products in Francehave been adopted by the French National Assembly and Senate.

The modernization law sets up a collective redress system for litigation similar to class action lawsuits available in the US, and will necessitate reorganization of the French Health Products Safety Agency (AFSSAPS) as well as promotion and advertising of medical devices, according to Eucomed.

Under the law, medical device and pharmaceutical firms would be required to make public all benefits and perks they provide to health care providers, hospitals, patient groups and media. The French Ministry of Health has argued that the threshold for reporting by firms should be €1, but the actual threshold amount will not be determined until finalization of the law.

The National Assembly and Senate must now hammer out a final version of the law; if no compromise can be reached, the National Assembly’s version of the law will stand. Final adoption of the law is expected by the end of 2011.

Markets: EuropeTags: class action, European Union, france, medical device

Author: Stewart EisenhartDate: November 7, 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

EU Considers Applying Transparency Directive to Medical Devices

The European Commission may extend its Transparency Directive covering pricing and reimbursement transparency of medicinal products to medical devices.

EU regulators have launched a public consultation in conjunction with a process review of the Transparency Directive (89/105/EEC) intended to revise pharmaceutical pricing rules, which have not been updated since 1989. In addition, the consultation will involve evaluating whether the directive should also apply to medical devices.

Contributions from interested parties will be accepted until May 25; commissioners are particularly interested in comments from economic operators, health care professionals, public interest organizations and national authorities.

If regulators ultimately do extend the Transparency Directive to medical devices, that could lead to a more simplified and efficient pricing and reimbursement infrastructure for manufacturers across Europe.

Markets: EuropeCategories: Regulatory ComplianceTags: 89/105/EEC, EU, european commission, European Union, Transparency Directive

Author: Stewart EisenhartDate: March 31, 2011