Industry News
IVD Directive Back on Track, Anselmann Tells MEDTEC Conference Attendees
Norbert Sparrow
Announcing that the contentious human tissue clauses have been separated from the main draft of the In Vitro Diagnostics Directive, Norbert Anselmann declared himself "not too pessimistic" about the future of the directive. Head of the medical devices sector within the European Commission's industrial affairs directorate, Anselmann indicated that the draft could be adopted by the European Parliament as early as the end of next year. He made these remarks at a session devoted to the Medical Devices Directive (MDD) at the recent Medical Equipment Design & Technology Exhibition & Conference (MEDTEC) in Amsterdam.
The clauses relating to medical devices that contain human tissue in article 19 of the draft directive have been under fire from French authorities, who are calling for stiffer regulatory requirements. While the French have been the most vocal in their objections, they are not alone. Portugal, which recently enacted its own IVD regulations despite strong opposition at the European level, and Italy have expressed similar concerns. Faced with a potential stalemate, the Committee of Permanent Representatives, a body that assists the Council of Ministers, reached an agreement to put the clauses on a separate approval track. This bodes well for the future of the IVD Directive, according to Anselmann. Following the common position (which was adopted by the council on 27 November), Anselmann anticipates a "very lively" second reading in the parliament. Assuming that the parliament does not demand another first reading of the document, which could conceivably doom the directive, Anselmann believes that the text could be adopted by the end of 1998. "All of the parties agree that there is a need to compromise," Anselmann told attendees, adding that in his view the two-track approach will help to achieve this.
Maurizio Suppo, until recently director of the European Diagnostic Manufacturers Association and currently principal consultant with Medical Technology Consultants (Brussels), was less sanguine about the future of the directive. Presenting a paper at a session devoted to the IVD Directive, Suppo stressed the serious impact the beleaguered directive is having not only on industry but on Europe's regulatory system as a whole.
"More delays mean more national initiatives," Suppo said, citing Portugal's IVD legislation as one example. The political nature of the discussion within the Council of Ministers, added Suppo, has resulted in heavy-handed regulatory proposals that are at odds with the new approach directives.
For example, said Suppo, French authorities have requested that Annex 2 products, which have already been through the conformity assessment process, be subjected to an additional 60- to 90-day delay before being placed on the market. During this time, conformity assessment documents would be distributed to the European Union's competent authorities. "This raises issues of translation," noted Suppo. "And what if a competent authority decides that it doesn't like this particular product?" Calling the proposal an unacceptable form of double approval, Suppo warned that this and similarly disturbing changes to the draft IVD Directive could "destroy the credibility of Europe's regulatory system."Michael Baker, director general of EUCOMED, who chaired three sessions at MEDTEC devoted to sterilization technology, commented that he had not yet seen anything in writing regarding the removal of the clauses. "I have been told it has happened, but only in verbal form," he said. Nevertheless, the decision was inevitable, said Baker, adding, "it seems to have paved the way for a common position under the Luxembourg presidency, which is a pleasant surprise for all concerned."
Is the MDD Working?
Yes . . . and non
The competence of some notified bodies was also debated at some length during the three-day MEDTEC conference. "How can an organization possibly have the expertise to assess compliance with the entire Medical Devices Directive?" asked one attendee during a lively question-and-answer period that followed the last of three sessions devoted to the MDD. Better surveillance of notified bodies is a crucial issue, agreed Anselmann, who suggested that if there were more cooperation among competent authorities, many of the perceived problems related to notified bodies would be resolved. "But [cooperation] is very difficult to achieve," he added.
Anselmann noted that an amendment to the MDD will underscore each notified body's responsibility to the competent authority. The notified body is obligated to withdraw or suspend certification if the conditions of the conformity assessment procedure were not met or are no longer being met, he told attendees. The amendment will clearly state that a notified body is required to report to the competent authority on this and any other situation that would ultimately involve the competent authority, he added. "This was not explicitly stated in the directive, although it should have been the practice all along," said Anselmann.
The amendment will also include a clause stating that the notified body must have sufficient in-house competence to perform conformity assessment procedures based on the essential requirements. The CE mark works, Anselmann stressed, adding that the commission was aware that "we need to improve the system." This acknowledgment was also intended to demonstrate that European authorities were not discounting French concerns that the system needed repairs. Opinions diverge, however, on the appropriate remedies.
Expressing concern over the adequacy of the directive to ensure the safety of CE-marked products, French officials have called for a substantial overhaul of the regulatory structure and are seeking to introduce a national premarket approval scheme for certain CE-marked high-risk devices. According to many observers, this would constitute a serious threat to the principle of new approach legislation and undermine the single market for medical devices.
Anselmann sought to reassure attendees that a dialogue had been established among the national competent authorities to address these issues in a meaningful way. "There are political discussions under way to keep the system credible," said Anselmann, "but these are not in the public domain. I can assure you," he stressed, "that we are talking about it."
Speaking to EMDM after the conference, Baker noted that, while EUCOMED is sympathetic to some of the concerns raised by French authorities, it also feels strongly that they should be addressed within the framework of the directives. "We are taking a positive approach," he said, "not launching a full frontal attack." That would simply not be a productive way to deal with this situation, he added.
EUCOMED has issued a position paper on the subject--"Reinforcing the Implementation of the Medical Devices Directive 93/42/EEC"--that restates the organization's commitment to the new approach concept and the MDD, urging that corrective action be engaged at a European level within the current regulatory framework. Notably, the document recommends effective promulgation of authoritative guidance on implementation issues. A means to achieve this at a European level, according to EUCOMED, would be to establish a committee that would consult with the Notified Bodies Recommendation Group and independent experts to address issues as they arise. The paper also proposes that surveillance systems be set up to oversee the selection of notified bodies and to monitor the fulfillment of their duties. Oversight procedures would include shadow audit teams.
"Reinforcing the implementation of the directive is key," said Baker. "We simply don't need one more layer of bureaucracy," he stressed. "That would undermine the whole concept of new approach legislation."
More than 20 sessions on topics ranging from regulatory issues to the technical aspects of medical device manufacturing were held at MEDTEC. Conference proceedings are available for purchase: contact Canon Communications LLC, 11444 W.Olympic Blvd., Santa Monica, CA 90405-3216, USA; phone: +1 310 3925509; fax: +1 310 3924920; E-mail: kim.askew@cancom.com.
Medical OEMs Source New Products and Servicesat MEDTEC
More than 1600 visitors representing Europe's leading medical device manufacturers attended the Medical Equipment Design & Technology Exhibition & Conference (MEDTEC) in Amsterdam on 2123 October, announced show organizer Canon Communications LLC. Medical OEMs were able to source industry-specific products, equipment, and services presented by more than 150 exhibitors during the two-day exhibition. Many of those exhibitors chose MEDTEC, which was sponsored by European Medical Device Manufacturer, as a venue to launch new products or focus attention on lines that held substantial promise for medical applications.
Bayer AG (Leverkusen, Germany) featured its Makrolon DP1-1805 and Texin 5590 resins. Makrolon, a lipid-resistant polycarbonate, is a less costly alternative to specialty polyurethane, polyetherimide, and polysulfone for medical connector applications. Texin is characterized by high impact strength and flexibility and resists abrasion, tearing, and tear propagation; the material is suited for thin-walled flexible tubing and catheters, incision films, and injection-moulded components. Bayer, which had never before presented these polymers at a show, reported "tremendous response" from visitors.
There was also a great deal of activity at the stand of Avery Specialty Tape Div. (Turnhout, Belgium), which unveiled its new hydrocolloids formulated without the use of animal-derived materials. The hydrocolloids have less irritation potential than many competing products, according to Colleen Ward, director of the division's medical business unit. For more information on this material, see the Technology News section in this issue.
Philips Power Systems (Wavre, Belgium) chose MEDTEC to introduce a range of open-frame, switched-mode power supplies for non-patient-connected medical applications. The components are highly reliable and include such features as overvoltage protection and current-limiting overload, all at a low price. Device manufacturers struggling with budgetary restrictions in the health-care sector took notice.
At the stand of Haemotronic S.p.A. (Mirandola, MO, Italy), the focus was on the company's newly introduced latex-free injection sites that are both EtO and gamma stable, its PVC-free bags, and the recently constructed cleanroom equipped with 10 injection moulding machines.
Lumonics (Puchheim, Germany) demonstrated the broad medical manufacturing applications of its laser-based systems both on the show floor and at a session during the accompanying technical conference. At the session, Lumonic's European product manager Alain Biernaux discussed the advantages of using laser equipment for everything from marking and engraving operations to the production of stents in cut widths down to 25 µm.
CAD/CAM systems developed by IBM/Dassault Systèmes (Suresnes, France) that were used by Aesculap AG & Co. KG (Tuttlingen, Germany) to design and manufacture prosthetic devices and medical instruments, and a stent-measuring system shown for the first time by RAM Optical Instrumentation (Irvine, CA, USA) were among the other highlights of the show.
The range of products and services displayed at MEDTEC was designed to provide one-stop sourcing for medical OEMs throughout Europe, and attendance figures released by Canon Communications indicate that the single-market aspirations of the event were fully realized. German visitors constituted almost a quarter of the attendees, with 20% hailing from the Netherlands, 15% from the UK, 10% from France, 7% from Belgium, 5% from Scandinavia, and 5% from Italy. Visitors from Eastern Europe (4%), the US (4%), and other non-Europe-based companies made a relatively strong showing as well. "MEDTEC is now uniquely established as the annual pan-European platform for companies and organizations to meet, discuss, and do business," said event director Diane O'Connor. "It's a single event for a single market."
Buoyed by the strong response to the show and conference, Canon has announced that the 1998 edition of MEDTEC will nearly double in size, with over 275 companies and organizations expected to take part. In addition, the exhibition will be extended from two to three days. The show and conference will take place at the RAI International Exhibition and Congress Centre on 68 October. For more information, contact MEDTEC, P.O. Box 12997, London NM5 2WX, UK; phone: +44 171 4854343; fax: +44 171 2672788.
