Health Telematics (AIM) Final Report


	Updated: Feb 1, 97
EUROMEDIES

European Medical device Information Exchange System

Project Code: A2122

Project value: 300 KECU

EC contribution: 300 KECU

No of partners: 23

No of countries: 11

Duration: 20 months

Contact:
Prof. Nicolas Pallikarakis
INBIT
Institute of Biomedical Technology
Ellinos Stratiotou 50A
GR-26441 Patras, Greece
Tel.: +30-61-65.28.15 / 65.28.51
Fax: +30-61-65.01.16

Project Overview

Over the past two decades, an exploding number of new technologies and applications has been introduced into the medical field, opening up amazing possibilities for diagnosis and therapy, but also raising questions of their appropriateness, safety and effectiveness. The E.U. shares today about 1/3 of the medical devices world market, which grows by almost 10% per year. A fragmentation of the European market, however, exists due to inconsistencies in national regulations imposing technical, physical and financial barriers.

The EC directives on medical devices provide for the necessary legal framework for hte free movement of the medical devices inside a single Community market. A considerable amount of the regulatory data will be generated within the Member States by manufacturers, competent authorities and notified bodies, once the Community legislation becomes applicable. THe implementatio of the E.U. directives will result in a considerable amount of regulatory data, generated by the involved parties: Competent Authorities (CA), Notified Bodies (NB), manufacturers and users, where an important part of these data shoud be transferred and made available to other bodies. This, in turn, will introduce an outstanding need for effective and efficient communication services.

Purpose and objectives

The main objective of EUROMEDIES Concerted Action was the investigation of the requirements for a centralised or distributed database, containing relevant regulatory data and incident reports, pertaining to the medical devices, as well as the telematics means for the exchange of this information between Member States and the Commission. The EUROMEDIES being a Concerted Action was not intended to come up with a system for direct exploitation. Each Competent Authority (CA) is responsible for developing its own organisational structure and telematics means in order to respond to the requirements of the Medical Device Vigilance System. However, all parties need to he part of a trans-European network and a standard way for transmission of the information is needed to be followed.

The contribution of this Concerted Action towards an efficient and effective use of telematics in the field of medical device vigilance has been accomplished by analysing data collection and information flow as they are dictated by the Medical Device Directives. More explicitly this was achieved through:

the identification of a basic data set concerning medical devices and an appropriate data model, covering the requirements of the vigilance system. The adoption of a common data set using also a universe nomenclature system is a perspective for the existence of a harmonised data exchange .system in the European Union.
the possibility of using EDI, (Electronic Data Interchange), for the transmission of regulatory data. EDI provides an efficient means of transposing data from one organisation's computer database into a computer database at another organisation in a predefined format. Its primary purpose is to speed the communication of information and the transmission may be direct between the involved parties or via a third party data communications organisation.
the adoption of appropriate security mechanisms in order to maintain confidentiality, integrity and availability of data. Security is an important issue for a trans-European information exchange system, since the system handles sensitive information that needs to be protected.
the assurance of compatibility between the medical device vigilance and the pharmacovigilance systems, to avoid potential overlaps and duplication of efforts.
the promotion of standardisation and consensus amongst all concerned parties.

Results

Within the scope of the EUROMEDIES Concerted Action, a pilot prototype system has been developed based on the above mentioned data model which deals mainly with the electronic transfer of the MDVS Dissemination Report, primarily for demonstration purposes. A standard format report form to be used for the exchange of information between CAs has been developed. However, since the pilot prototype has been based on consensus amongst all concerned parties involved in the medical device vigilance system, it should now pass into validation trials. During this phase the prototype can, thus, become a working system to be used by the member states for the exchange of regulatory information. Funding of this activity in order to achieve this goal is of course a necessary prerequisite and is expected to be obtained in the near future.

List of Deliverables

Requirement analysis - initial report
Report on security aspects
Report on interrelation with pharmacovigilance
Proposed system specifications
Final report

List of Participants

Mr John Davey The SSADM College Limited Ewel Road 11 Surbiton KT6 7BB, U.K. Tel.: +44-181-390.00.62 Fax: +44-181-390.00.72	Mr Jose Luis Monteagudo Ministerio de Sanidad y Consumo Sinesio Delgado 6 E-28029 Madrid, Spain Tel.: +34-1-314.24.13 Fax: +34-1-315.01.28
Mr Reymond de Roo Ministere de la Sante Publique Cite Administrative de l'Etat Quartier Vesale B-1010 Bruxelles, Belgium Tel.: +32-2-210.48.90 Fax: +32-2-210.48.80	Mrs Bodil Dejgaard Sundhedsministeriet Herluf Trollesgade 11 DK-1052 Copenhagen, Denmark Tel.: +45-33-92.48.62 Fax: +45-33-93.15.63
Dr Gert Schorn Regierungsdirektor Bundesministerium fuer Gesundheit Deutschherrenstr. 87 D-53177 Bonn, Germany Tel.: +49-228-941.33.70 Fax: +49-228-941.49.33	Mrs Carmen Abad Luna Ministerio Sanidad y Consumo, Direccion General de Farmacia y Productos Sanitarios Paseo del Prado 18/20 E-28071 Madrid, Spain Tel.: +34-1-596.43.47 Fax: +34-1-596.44.00
Mr Virefleau Ministere de la Sante Direction des Hopitaux 1 Place de Fontenoy F-75330 Paris 07SP, France Tel.: +33-1-40.56.46.67 Fax: +33-1-40.56.50.45	Dr. Gerard Scharll Ministere de la Sante 4 Rue Auguste Lumiere L-1950 Luxembourg Tel.: +352-408.01
Mr Paul Synnott Department of Health Poolbegstreet IRL-Dublin 2, Ireland Tel.: +353-2-71.47.11 ext. 26.70 Fax: +353-2-71.19.47	Prof Sargentini Direzione Generale Servicio Pharm. Ministerio Sanita Via Civilta Romana 7 I-00144 Roma, Italy Tel.: +39-6-592.53.60 Fax: +39-6-592.58.24
Mr Massimo Neroni Laboratorio di Ingegneria Biomedica Instituto Superiore di Sanita Viale Regina Elena 299 I-00161 Roma, Italy Tel.: +39-6-49.90 Fax: +39-6-444.00.71	Mr Ancko de Vries Ministerie van Welzijn, Volksgezondheid en Cultuur Sir Winstonchurchillaan 368, Postbus 5406 NL-2280 HK Rijswijk, The Netherlands Tel.: +31-70-340.68.94 Fax: +31-70-340.71.87
Mr Fritz de Ranitz TNO Zernikedreef 9 PO Box 430 NL-2300 AK Leiden, The Netherlands Tel.: +31-71-18.12.49 Fax: +31-71-18.19.02	Mr John Worroll Department of Health Medical Devices Directorate 14 Russell Square, London WC1B 5EP, U.K. Tel.: +44-71-636.68.11 Fax: +44-71-93.15.63
Mr Eduardo Caetano Ministerio da Saude Escola Nacional de Saude Publica Av. Joao Crisostomo 9 P-1000 Lisboa, Portugal Tel.: +351-1-757.55.99 Fax: +351-1-758.27.54	Mr Angelos Dargentas Dept. of Biomedical Technology Ministry of Health Aristotelous 18 GR-Athens, Greece Tel.: +30-1-523.58.27 Fax: +30-1-524.06.49
Mr Richard Moore Comite Europeen de Normalisation (CEN) Rue de Stassart 36 B-1050 Bruxelles, Belgium Tel.: +32-2-519.68.11 Fax: +32-2-519.68.19	Mr Jos Kestens Comite Europeen de Normalisation Electrotechnique (CENELEC) Rue de Stassart 35 B-1050 Bruxelles, Belgique Tel.: +32-2-519.68.71 Fax: +32-2-519.68.19
Mr Bernd Lehmann Philips Medical Systems Building QM-247 PO Box 10000 NL-5680 BA Best, The Netherlands Tel.: +31-40-76.21.01 Fax: +31-40-76.30.17	Mr Tom Morrisson European diagnostic manufacturers association (EDMA) Boulevard Louis Schmidt 87 B-1040 Bruxelles, Belgium Tel.: +32-2-732.52.60 Fax: +32-2-732.65.11
Mrs Vicki Dedrick European confederation of medical suppliers' association (EUCOMED) Boulevard Louis Schmidt 87-Bte 3 B-1040 Bruxelles, Belgium Tel.: +32-2-732.43.20 Fax: +32-2-732.57.51	Mr Wallroth EUROM VI Dreagerwerk Moislinger Allee 53/55 D-23558 Lübeck, Germany Tel.: +49-451-882.22.67 Fax: +49-451-882.37.33
Mr Jan Thalen International Association of medical prosthesis manufacturers (IAPM) 19/21 Rue Capouillet B-1060 Bruxelles, Belgium Tel.: +32-2-536.86.47 Fax: +32-2-536.86.00	Prof Niilo Saranummi VTT Technical Research Centre of Finland Medical Engineering Laboratory SF-33101 Tampere, Finland Tel.: +358-31-16.33.42 Fax: +358-31-17.41.02
Mr Jan Randa Dpt of Clinical and Biomedical Engineering Haukeland University Hospital NKKN N-5021 Bergen, Norway Tel.: +47-5-97.48.60 Fax: +47-5-97.48.71



	Copyright 1997 © EHTO All rights reserved This server is the only official EHTO WWW knowledge repository. Mail suggestions to: webmaster@ehto.org