Special Report on Testing and Certification
MRA: INCHING TOWARD A UNIFIED GLOBAL MARKET
While most industry analysts applaud the recently initialled mutual recognition agreement, they caution that it should be viewed as a significant milestone on the road to harmonization, not the final destination.
Gabriel Spera
Representatives from the EU and US recently initialled a framework document that paves the way for mutual recognition of conformity assessments and product approvals. Manufacturers on both sides of the Atlantic have hailed the agreement as a major step forward, but many still feel that it doesn't go far enough.
The mutual recognition agreement (MRA) will allow authorized certification organizations, known as conformity-assessment bodies, to inspect production facilities and conduct premarket evaluations with regard to overseas regulations. In other words, a German notified body could certify that a German manufacturer complies with the US quality system regulation (QSR) program. This is still a long way from the ideal situation, in which the German manufacturer, by virtue of achieving ISO 9000 certification, would automatically be deemed in compliance with US FDA regulations. EU manufacturers who want to market their products in the US will still need two quality system certifications--one for the ISO/EN standards and another for the QSR standards--even though the QSR is nearly identical to ISO 9000. The advantages, however, will be that the same testing house can provide both certifications and that tests required by both regulatory schemes will not need to be performed twice.
FDA Pilot ProgramOne of the biggest problems with the MRA stems from its connection to FDA's third-party review pilot program that was initiated last year. The program, which borrows from the EU system, allows designated testing houses--analogous to Europe's notified bodies--to certify certain low-risk Class I and Class II devices for compliance with FDA regulations. A total of 37 testing houses expressed an interest in joining the program, but only seven were initially selected. Moreover, the program got off to a very slow start, and few eligible 510(k)s have been submitted to third-party assessors. The British Standards Institute (BSI; London), a UK notified body, was the only third-party inspector without a US branch to be admitted into the program. According to Peter Walker, who heads the program at BSI, European manufacturers have expressed "some interest," but mostly "for devices that are not covered by the pilot scheme." The program initially covered some 221 Class I devices and another 30 Class II devices. More Class II devices will be phased in, but only after FDA writes device-specific review guidance for each of them. "So," says Walker, "we've not been able to help."
Industry watchers in both the EU and US are skeptical about the future of the third-party review program, but not necessarily for the same reasons. Don Grabarz of International Regulatory Consultants (Salt Lake City) expresses the US opinion: "From a practical point of view, why should someone pay a third party to do something that is already built into the FDA budget?" Such sentiment runs counter to the European view, as espoused by Alan Kirwilliam of AMTAC Certification Services Ltd. (Altrincham, Cheshire), a UK notified body. "In the US, you have taxpayers funding FDA," says Kirwilliam. "They're paying the policeman, when really, shouldn't manufacturers pay for access to the market?" Grabarz also notes that turnaround at FDA has improved dramatically since the program was first proposed, so the need for third-party reviewers doesn't seem as urgent as it once did. Walker adds that the specific devices covered by the program usually received the fastest approvals anyway.
Safeguarding Confidential Data
FDA has no transparent process in place for selecting and authorizing third-party reviewers. In evaluating the original applications, says Walker, FDA was most cautious about ethical questions and conflicts of interest, and wanted proof that the testing houses were independent, had no arrangements with manufacturers, and could vouchsafe the integrity of their personnel. Grabarz adds that US manufacturers have expressed concern over confidentiality, and that they tend to trust FDA with their trade secrets more than a contract assessor. The MRA takes steps to ensure both the protection of confidential data and the availability of information that is within the scope of the public interest.
The MRA would open up the program to allow all European notified bodies to review 510(k)s against US requirements and submit the reviews to FDA for final action. The MRA provides a three-year trial period, after which a consensus will be rendered as to which EU notified bodies have demonstrated their ability to review products in accordance with FDA standards. This alone could lead to problems because of the two very distinct cultures involved. According to Kirwilliam, "FDA is seen by some entities as being litigious, seeking information for future litigation. In Europe, notified bodies are seen as facilitating manufacturers' compliance with the law." Walker agrees, citing as an example internal audits. "FDA would never ask to see an internal audit," says Walker, because it might reveal problems that would require adverse action. "In Europe, we see the process as cooperative. If we can help clients by looking at their internal audits, they will appreciate that. FDA is still seen as a confrontational assessment body."
Regardless of its drawbacks, there's no doubt that the MRA represents "a major milestone," in Kirwilliam's words. EU and US regulatory bodies currently spend a lot of money performing overseas inspections each year, and the document will certainly put an end to this. The practice wasn't very effective anyway, notes Walker, because it simply wasn't economical for FDA to visit manufacturers of low-risk devices. EU manufacturers also spend a lot of time and money retesting their products upon arrival in the US; the agreement should enable manufacturers to streamline the process by having a single notified body perform the certifications needed for both EU and US distribution. The MRA also contains the core of an early-warning system to expedite the exchange of product vigilance reports.
Harmonized Biocompatibility Standard
It will probably take at least a year before the MRA is ratified. In the meantime, manufacturers can hope to reap the benefits of a harmonized ISO 10993 bicompatibility standard. According to Norbert Janzen of TÜV Product Service GmbH (München), a German notified body, the harmonized standard should simplify both the preparation and review of design dossiers and technical documentation. A manufacturer would simply have to show that the product had been tested and found to comply with ISO 10993, Janzen says, "So it's not really necessary to provide all the single test data." The harmonized standard will also make it easier to compare data on competing products from different manufacturers, and overall should help EU manufacturers get their products to the US market faster and less expensively.
Various working groups have been hard at work on the standard and are making steady progress. WG 14, for example, has been focussing on materials characterization--an issue that will only increase in importance, says Dick Wallin of NAMSA (Münster, Germany), a contract testing house with facilities in the US and EU. Materials characterization, he explains, is "a way of fingerprinting a sample" to ensure that the material that goes into a product is the same one that passed inspection. Established protocols, he says, will determine how much testing is performed and what will actually need testing. NAMSA expects further important developments from WG 6, focusing on genotoxicity, and WG 9, concerning haemocompatibility.
"Harmonization has been and will continue to be an evolutionary process," says Grabarz, who assists companies in obtaining the CE mark. The goal of a unified global market is still far off, but by encouraging international cooperation and compromise, the MRA and harmonized standards will bring that goal closer, one step at a time.
ILLUSTRATION BY JENNIFER FIELD
