EMDT_European Medical Device Technology

European Medical Device Technology, Spring 2014

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emdt.co.uk European Medical Device Technology Spring 2014 | 27 EU Process for Technical Legislation This article addressed only one aspect— clinical data—of the proposed regulation for medical devices. But a review of the remaining proposed EP amendments may lead some to conclude that the process of revising such important regulatory require- ments has left much to be desired and is breathtaking in its shortcomings. To name just a few flaws, the current legislative process has clearly failed to ensure that only those with requisite knowl- edge and expertise have provided the most input into the proposed amendments, and it has clearly failed to keep political influence to an absolute minimum. Unfortunately, we have to live with the current system and hope for the best. In this respect, it is welcomed that the Council is taking all the time it needs in an effort to ensure that the new regulations are reasonable, constitute an improvement over the current system, will not discourage the introduction of ben- eficial medical technology in Europe, and will be successfully implemented. The European Commission's proposals for medical devices and IVDs, combined, totaled nearly 400 pages with 138 recitals or introductory statements, 187 articles, and 30 annexes; more than 600 amend- ments were proposed by the EP. The EP elections will be held in May, and newly elected members, potentially having even less knowledge of the proposed regulations, will then become involved in the legislative process as well. The importance of the work that still needs to be done, together with its associated challenges under the European legislative process, cannot be overstated. References 1. Proposal for a Regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009; http://ec.europa.eu/ health/medical-devices/files/revision_docs/ proposal_2012_542_en.pdf 2. Proposal for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical; http://ec.europa.eu/ health/medical-devices/files/revision_docs/ proposal_2012_541_en.pdf 3. Amendments adopted by the European Parliament on 22 October 2013 on the proposal for a regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009; www.europarl.europa.eu/ sides/getDoc.do?type=TA&language=EN&refe rence=P7-TA-2013-428 4. Proposal for a Regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC; http:// ec.europa.eu/health/files/clinicaltrials/2012_07/ proposal/2012_07_proposal_en.pdf EUROFLEX GmbH, Kaiser-Friedrich-Str. 7, 75172 Pforzheim, Germany, Tel. +49(0)7231.208.210, Fax +49(0)7231.208.7599, info@euroflex.de www.euroflex.de EUROFLEX is your partner for future developments in the medical device industry. Together with you, we develop the next generation creative solutions using innovative materials. High-grade semi-finished products, components and actuators from a variety of materials for medical applications. EUROFLEX - Precision products for the highest quality demands Highest Precision for Medical Engineering NITINOL STAINLESS STEEL, NI-FREE ALLOYS COBALT-BASED ALLOYS TITAN-BASED ALLOYS TANTALUM PRECIOUS METALS PLATINUM ALLOYS BIOABSORBABLE ALLOYS MATERIAL COMPOUNDS ... Maria E. Donawa, M.D. President, Donawa Lifescience Consulting Piazza Albania, 10 - 00153 Rome, Italy Tel: +39 06 578 2665 medonawa@donawa.com www.donawa.com Visit us at MEDTEC Europe Stand 7D10 ES433894_EMDT1405_027.pgs 05.02.2014 14:04 UBM black yellow magenta cyan

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