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.

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

EDMA Study: European IVD Market Stagnating

A new report examining European in vitro diagnostic (IVD) market performance in 2010 sees flat or negative growth across most major EU member states due to cost containment measures and worsening economic conditions.

According to the European Diagnostic Manufacturers Association’s (EDMA) study, the European IVD market totaled €10.5 billion last year, with revenue growth of only two percent from 2009. Cardiology testing and diabetes-related IVD sectors as well as products for managing hospital-acquired infections showed the strongest growth rates in 2010, but all other testing areas showed flat or negative growth.

EMDA attributes these rates to European governments’ placing of limitations on IVD testing volumes and reimbursement to balance budgets. (Efforts by governments to implement ill-conceived austerity measures are also not helping.)

Germany remains Europe’s largest IVD market, but IVD revenue growth there was -0.01% in 2010 following a decision by the Federal Joint Committee to end reimbursement for some diabetes-related tests via statutory health insurance.

In France, new laws allowing consolidation of private laboratories also boosted procurement consolidations in 2010. Growth in the glucose self-testing segment totaled 6.4%, but all other IVD segments remained flat over the same period. Price decreases, Cost per Reportable Result (CPRR) efforts and more demanding customers all affected poor growth rates overall, according to EDMA.

The Italian IVD market showed modest growth (1.1%) last year, but late payments of as many as 700 days plagued the region; the market in Italy will likely face greater challenges as the country’s economy worsens.

Spain’s IVD market also grew slightly in 2010, by 0.5%, but EDMA expects pricing pressures to make Spanish market conditions more challenging for IVD manufacturers.

The UK has no official IVD reimbursement system in place, but cost containment efforts there have nonetheless driven laboratory consolidations. Efforts to contain the National Health System’s budget are also drawing more private-sector providers into the British IVD market.

It is difficult to see European IVD growth rates improving substantially going forward, as Continental governments large and small continue tightening health care-related budgets under the questionable assumption that austerity will stave off recession.

Markets: EuropeTags: austerity, edma, EU, Europe, European Diagnostic Manufacturers Association, in vitro diagnostic device, IVD

Author: Stewart EisenhartDate: November 16, 2011

Medical Device Trade Groups Sign On to Global Compliance Statement

Nine medical device industry associations have signed on to the Global Compliance Statement on Interactions Between Medical Technology Companies and Healthcare Professionals (HCPs), a document intended to promote ethically sound interactions between the groups’ member firms and health care providers.

The Advanced Medical Technology Association (AdvaMed), Eucomed and the European Diagnostic Manufacturers Association (EDMA) first signed on to the document in 2010; six additional groups—the European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry (COCIR), the International Medical Devices Manufacturers Association (IMEDA), MEDEC, the Medical Technology Association of Australia (MTAA), the Medical Technology Association of New Zealand and the South African Medical Device Industry Association (SAMED)—signed the document during the 2011 International Medical Device Industry Compliance Conference in London, according to a Eucomed press release.

Specific efforts the associations have agreed to undertake include pushing their respective members to adopt compliance policies and procedures in line with industry codes; providing guidance to industry regarding ethical business conduct when engaging with health care professionals; keeping members informed of relevant laws, regulations and professional codes that impact how firms interact with health care professionals; and collaborating to increase adoption of ethical codes of conduct on a global scale.

Buy-in of the global compliance statement among a significant number of trade groups representing various medical device markets no doubt reflects a more advanced and nuanced level of maturity of the industry as a whole—but also the need for member companies to establish adequate processes and procedures in the face of growing regulatory interest.