Medical Device Blog – QA & Regulatory Updates from Emergo Group

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. 

Mexican medical device regulators plan to establish simplified registration for in vitro diagnostics and other low-risk products, and to exempt another 1,700 health products from medical device registration requirements altogether in an effort to increase market competition, improve public health and boost job creation.

According to officials at COFEPRIS (document in Spanish), the regulator’s moves are based on methods endorsed by the Federal Regulatory Improvement Commission (COFEMER) and recommendations from the Organization for Economic Cooperation and Development (OCDE).

Along with IVDs, COFEPRIS plans eased registration for hygienic products, healing products and dental supplies. As for the 1,700 products that will no longer require registration as medical devices, COFEPRIS will publish a list of these goods in August on its website, www.cofepris.gob.mx.

Simplified registration requirements for IVDs should boost the Mexican market’s appeal for IVD manufacturers looking to expand into new markets. Emergo Group will continue to monitor the situation for further details.

The European Union’s Restriction on Hazardous Substances (RoHS) Directive covering electronic devices will soon also cover medical devices.

The law has been fashioned to improve collection and recycling rates of electronic devices across the EU, as well as to cut down on illegal exporting of electronic waste products from the EU.

According to a Massdevice.com report, medical devices and IVD products had previously been exempted from the RoHS, but that exemption will not be extended except for active implants. As such, medical devices and monitoring and control instruments will have three years to comply with RoHS following the directive’s adoption; IVD products will have five years to comply.

The law has been fashioned to improve collection and recycling rates of electronic devices across the EU, as well as to cut down on illegal exporting of electronic waste products from the EU.

The European Parliament adopted the text of the RoHS recast late last year; MassDevice.com cites reports from BSI that final approval of the law is imminent.

The RoHS currently restricts lead, mercury, cadmium, hexavalent chromium, PBB and PBDE; according to BSI, the directive’s list of restricted substances is likely to expand. 

The Therapeutic Goods Administration (TGA), Australia’s medical device regulator, has specified which in vitro devices (IVDs) will be required to undergo application audits.

According to Australia’s Therapeutic Goods (Regulations) 2002, eight types of IVDs fall under the application audit requirements:

• Non assay-specific quality control materials for monitoring Class 4 IVDs
• IVDs for self-testing applications
• IVDs for point-of-care testing
• Class 3 IVDs for detecting sexually transmitted agents
• IVDs to monitor treatment of infections diagnosed with Class 4 devices
• IVDs supplied for use according to the pharmaceutical benefit scheme
• IVDs used in national screening programs
• IVDs whose original manufacturing evidence does not fully satisfy Australian conformity assessments

IVD manufacturers and their sponsors whose products do not qualify for the mandatory audit requirements, however, should not consider themselves off the hook. The TGA also has the authority to select applications for such devices for non-mandatory audits, as well. In either case, the TGA will send written request to the sponsor for information necessary to conduct the application audit.

An application audit by the TGA will entail review of a manufacturer’s technical documentation; any data or documentation deemed by the regulator to be relevant to demonstrable compliance with safety and performance Essential Principles, conformity assessment procedures or advertising or supply information is fair game.

Sponsors should not submit application audit documentation until the TGA formally requests that information, advises the regulator’s website.