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The Council of Ministers of the European Union will hopefully reach a common position on a directive on in vitro diagnostics (IVD's) by mid-2009, European Commission principal administrator, told the Global Medical Device Conference. He also confirmed that the IVD CE mark Directive is expected to be the vehicle for regulating devices based on viable human tissue. These devices were excluded from the scope of the existing EU Medical Devices Directive (93/42) because of opposition from the European Parliament.
However, the European Parliament appears to have been persuaded that viable human tissue devices are acceptable and will formally be included within the ambit of the device legislation rather than continuing to be subject to different rules in each EU Member State.
The timetable Anselmann is hoping for could be optimistic. Industry sources have told MBDN discussion on the directive has become bogged down at a childish level of detail. Moreover, the French government is vehemently opposed to the concept of the directive - a switch from a system of centralized regulation to one based on certification, including the ISO 9000 series. If the French don't change their stance, this would delay final adoption expected to follow second reading by the European Parliament by end-2009. Member States would then have two or three years to transpose the directive into national legislation. A transitional phase would be granted during which manufacturers could comply with the new or the old rules.
In anticipation of adoption of the Directive, the Commission is making progress, Anselmann said, on the subjects on which the European standardization bodies (CEN and CENELEC) will be asked to draw up standards to underpin the directive. These include: performance evaluation; reference material traceability; sterility and microbiological status; stability testing; labeling and symbols; and IVD's for self-testing including glucose meters, laboratory equipment safety and software. The industry will be formally consulted on this program before it is passed to CEN/CENELEC.
One of the key issues in the debate is language. The Parliament, and many Member States, support local language labeling, arguing that professional users, such as nurses, cannot be expected to speak English. If provisions require different labels and packs for different countries - covering 11 languages - companies claim it would cost those millions of dollars, which under government cost containment policies, cannot be passed on through pricing. The Commission itself recognizes that this would defeat the purpose of having a system that enables manufacturers to sell anywhere in the EU on the basis of marketing authorization from a single Member State. It, therefore, has resisted pressure from the European Parliament for systematic local language labeling. The final wording of the directive is likely to leave it to Member States to decide on language requirements - and possibly to decide differently for each class of product.
Another area where there is still intensive discussion among Member States and the Commission is the list of devices which will have to be submitted for third party review. The list will certainly extend to reagents and reagent products for blood grouping (A, B, O and Rh./ D), but anti-Kell and Rh (C, c, E, e) are under discussion. It will include reagents and reagent products for the detection in human specimens of markers of HIV infection (HIV1 and 2), hepatitis B, C and D, but the inclusion of HTLV 1 and 2 are still a matter for debate. Reagents and reagent products for the detection in human specimens of markers of rubella and toxoplasmosis will certainly be on the list of IVD CE Mark, but cytomegalovirus may also be included.
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