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General Statement and aim of the EBCP CE Product Complaint Support
Activity General Statement: Since June 1998, CE Marking is a legal requirement stating that certain medical products sold to the countries of the European Union (EU) must be approved by a notified body indicating that they have met the essential requirements set out by the Medical Device Directives (MDD). Although these requirements are six years ago, very little is known by the medical community regarding the steps in reporting product deficiencies and subsequent accidents. ________________________ The Aim of EBCP Support: The EBCP is committed to providing assistance in this process by providing a central contact point through which questions may be directed regarding the steps involved in filing a product complaint and the contact numbers needed in reporting a product deficiency.
The EBCP intent is to improve patient safety through enhancing the
initiation of a product complaint process and promoting the reporting of
product deficiencies and any accidents related to a product by
perfusionists.
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Clarification as to the Role, Limits, and Assistance of EBCP in
Individual Cases Clarification of EBCP Support: The EBCP does not legally bind the itself to any complaint process, nor is it responsible for any misinformation which leads to a delay in problem reporting. All information contained in a complaint process or incident report will be kept confidential unless it is deemed necessary by both the EBCP and those initiating the process. ____________________________________________________________ Limits of the EBCP Role in Individual Product Complaint Processes REPORTING OF CASES is a vital aspect of device regulation. Documenting strengths and weaknesses of devices after the product has been in clinical use for a number of years is the only way to maintain quality control, for it is only then that technical problems become apparent. Responsible health care providers in the EU should report problems to the manufacturers and regulatory authorities so that hazards can be promptly identified. ________________ EBCP Assistance The EBCP will help in this process by: 1) providing contact information and clarifying the possibilities and priorities involved in the reporting procedure for deficient cardiopulmonary related medical devices, 2) for action on the safety of cardiopulmonary related medical devices which may aid in presenting appropriate proposals, and 3) clarifying for health care professionals in the EU seeking advice in the reporting procedure and the issues related to perfusion products covered under CE Safety Compliance Requirements.
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CE Medical Device Regulations, Policy and Guidelines The Medical Device Directives (MDD) consists of 75 pages (12 point) divided into: Introduction, Articles (23) and Annexes (12). Article 1; Definitions Article 2; Placing on the market and putting into service Article 3; Essential requirements Article 4; Free movement, devices intended for special purposes Article 5; Reference to standards Article 6; Committee on Standards and Technical Regulations Article 7; Committee on Medical Devices Article 8; Safeguard clause Article 9; Classification Article 10; Information on incidents occurring following placing of devices on the market Article 11; Conformity assessment procedures Article 12; Particular procedure for systems and procedure packs Article 13; Decisions with regard to classification, derogation clause Article 14; Registration of persons responsible for placing devices on the market Article 15; Clinical investigation Article 16; Notified bodies Article 17; CE marking Article 18; Wrongly affixed CE marking Article 19; Decision in respect of refusal or restriction Article 20; Confidentiality Article 21; Repeal and amendment of Directives Article 22; Implementation, transitional provisions Article 23; This Directive is addressed to the Member States The Annexes describe in detail the :
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EBCP Documentation and an Information System for Accidents, Product
Failure, Safety Problems, and Related Reports Maintain documentation and an information system for accidents, product failure, safety problems, and related reports. This information cannot be accessed online. The EBCP will store and use the information as reference material and may provide comments and/or advice from its content which is found to be pertinent to a specific case or aid in reporting of medical device problems.
All information will be confidential so that the person (s) reporting a
problem will remain anonymous.
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Websites and Links: useful EMC/Safety Information. The following websites are helpful in learning about CE Marking
The Gateway to European Union
Guidelines relating to medical devices Directives: http://www.europa.eu.int/comm/enterprise/index_en.htm http://www.mdieuropa.com/mdd_pages/harmonizedlist.htm www.europa.eu.int/comm/enterprise/medical_devices http://www.fda.gov/cdrh/dsma/dsmamain.html
Enterprise Europe Newsletter You can also consult or download electronic editions using the links on this page. http://www.europa.eu.int/comm/enterprise/library/enterprise-europe/index.htm
Guidelines relating to medical devices Directives http://www.europa.eu.int/comm/enterprise/medical_devices/meddev/index.htm
Medical Devices Directive (MDD)
List of Notified Bodies http://www.europa.eu.int/comm/enterprise/newapproach/legislation/nb/notified_bodies.htm http://www.europa.eu.int/comm/enterprise/newapproach/legislation/nb/en93-42-eec.pdf
List of vigilance contact points within the National/Competent
Authorities AUSTRIA - BELGIUM - BULGARIA - CYPRUS - CZECH REPUBLIC - DENMARK - ESTONIA - FINLAND - FRANCE - GERMANY - GREECE - HUNGARY - ICELAND - IRELAND - ITALY - LATVIA - LITHUANIA - LUXEMBOURG - MALTA - NETHERLANDS - NORWAY - POLAND - PORTUGAL - ROMANIA - SLOVENIA - SLOVAKIA - SPAIN - SWEDEN - SWITZERLAND - TURKEY - UNITED KINGDOM http://www.europa.eu.int/comm/enterprise/medical_devices/ca/list_ca.htm
List of Notified Bodies with CE Marking Number http://www.europa.eu.int/eur-lex/pri/en/oj/dat/2003/c_302/c_30220031212en00010414.pdf
List of notified bodies designated by the Member States and the EFTA Countries (EEA Members) under the new approach Directives (Text with EEA relevance.) (The list also includes notified bodies from Candidate Countries as well as designated conformity assessment bodies from third countries with whom the EC has concluded a Mutual Recognition Agreement (MRA).) Official Journal C 302 , 12/12/2003 P. 0001 0414
New Approach Standardisation in the Internal Market http://www.newapproach.org/home.asp CEN, CENELEC, ETSI and their National Members
Nando Information System This site will enable you to find the European notified bodies as well
as third country bodies designated under formal agreements [Mutual
Recognition Agreements (MRAs), Protocols to the Europe Agreements on
Conformity Assessment and Acceptance of Industrial Products (PECAs) and
European Economic Area (EEA)] responsible for carrying out the
conformity assessment procedures referred to in the applicable New
Approach directives.
For further information: European Commission Enterprise DG, unit G.1 B-1049 Brussels Belgium Fax: +32 2 295 97 84 E-mail: entr-regul-coord-mra@cec.eu.int |
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EBCP contact is.. Carole Hamilton |
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