MDD 93/42
NOTIFIED BODIES: MEDICAL DEVICES 93/42/EEC
Belgie / Belgique / Belgium
NB 1639 SGS Belgium NV
Ceska Republika / Czech Republic
NB 1014 ELEKTROTECHNICKÝ ZKUŠEBNÍ ÚSTAV, s.p.
NB 1015 STROJIRENSKY ZKUSEBNI USTAV s.p.
NB 1021 TEXTILNÍ ZKUŠEBNÍ ÚSTAV s.p.
NB 1023 INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s.
Danmark / Denmark
NB 0543 DS Certificering A/S - Danish Medical Devices Certification
Deutschland / Germany
NB 0044 TÜV NORD CERT GmbH
NB 0118 LANDESAMT FÜR MESS- UND EICHWESEN THÜRINGEN
NB 0123 TÜV SÜD Product Service GmbH
NB 0124 DEKRA Certification GmbH
NB 0197 TÜV Rheinland LGA Products GmbH
NB 0297 DQS Medizinprodukte GmbH
NB 0366 VDE - Prüf- und Zertifizierungsinstitut GmbH
NB 0432 MATERIALPRÜFUNGSAMT NORDRHEIN-WESTFALEN (MPA NRW)
NB 0481 ECM-ZERTIFIZIERUNGSGESELLSCHAFT FÜR MEDIZINPRODUKTE IN EUROPA MBH
NB 0482 MEDCERT ZERTIFIZIERUNGS- UND PRÜFUNGSGESELLSCHAFT FÜR DIE MEDIZIN GMBH
NB 0483 MDC MEDICAL DEVICE CERTIFICATION GMBH
NB 0494 SLG PRÜF UND ZERTIFIZIERUNGS GMBH
NB 0535 EUROCAT - INSTITUTE FOR CERTIFICATION AND TESTING GMBH
NB 1275 LGA INTERCERT ZERTIFIZIERUNGSGESELLSCHAFT MBH
NB 2004 Bureau Veritas Consumer Product Service Germany GmbH
Ireland / Eire
NB 0050 National Standards Authority of Ireland (NSAI)
Ellada / Greece
NB 0653 RESEARCH CENTER FOR BIOMATERIALS S.A. "EKEVYL S.A."
España / Spain
NB 0318 AGENCIA ESPAÑOLA DE MEDICAMENTOS Y PRODUCTOS SANITARIOS
France
NB 0459 Laboratoire national d'essais / G-MED
Italia / Italy
NB 0051 IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.
NB 0068 IRCM ISTITUTO DI RICERCHE E COLLAUDI MASINI S.R.L.
NB 0373 ISTITUTO SUPERIORE DI SANITA
NB 0398 APAVE ITALIA CPM SRL
NB 0425 ICIM - ISTITUTO DI CERTIFICAZIONE INDUSTRIALE PER LA MECCANICA S.P.A.
NB 0426 ITALCERT SRL
NB 0476 CERMET S.c. a r.l.
NB 0477 BIOLAB SPA - CENTRO DI ANALISI E RICERCHE BIOLOGICHE
NB 0546 CERTIQUALITY S.R.L. - ISTITUTO DI CERTIFICAZIONE DELLA QUALITA'
NB 1936 TUV Rheinland Italia SRL
Lietuva / Lithuania
NB 1609 SERTIKA - CERTIFICATION CENTRE FOR ELECTRONIC EQUIPMENT COMPANY LTD
Luxembourg
NB 0499 SOCIETE NATIONALE DE CERTIFICATION ET D'HOMOLOGATION S.À.R.L. (SNCH)
Magyarorzag / Hungary
NB 1007 MAGYAR ELEKTROTECHNIKAI ELLENŐRZŐ INTÉZET KFT.
NB 1011 ORVOS- ÉS KÓRHÁZTECHNIKAI INTÉZET (ORKI) (INSTIT. FOR MEDICAL AND HOSPITAL ENGIN.)
NB 1979 SGS Hungária Minoségellenorzo, Kereskedelmi és Szolgáltató Kft.
Nederland / Netherlands
NB 0344 KEMA Quality B.V.
Österreich / Austria
NB 0408 TÜV AUSTRIA SERVICES GMBH
NB 0636 PRÜFANSTALT FÜR MEDIZINISCHE GERÄTETECHNISCHE UNIVERSITÄT GRAZ
Polska / Poland
NB 1434 POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.
NB 1435 INSTYTUT WLOKIENNICTWA
NB 1451 OSRODEK BADAWCZO-ROZWOJOWY PREDOM-OBR
NB 2274 TUV NORD Polska Sp. z o.o
NB 2282 DQS Polska Sp. z o.o
Portugal - Vigilance
NB 0503 INSTITUTO NACIONAL DA FARMACIA E DO MEDICAMENTO
Romania
NB 1868 Oficiul Tehnic de Dispozitive Medicale-OTDM CERTIFICARE
Slovenija / Slovenia
NB 1304 SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ
Slovenska Republika / Slovakia
NB 1293 EVPU a.s.
NB 1297 VYSKUMNY USTAV ZVARACSKY - PRIEMYSELNY INSTITUT SLOVENSKEJ REPUBLIKY
NB 1299 Technicky skusobny ustav Piestany s.p.
NB 2265 3EC International a.s.
Suomi / Finland
NB 0537 VTT Expert Services Oy
Sverige / Sweden
NB 0402 SP Sveriges Tekniska Forskningsinstitut AB
NB 0413 INTERTEK SEMKO AB
United Kingdom
NB 0086 BSI
NB 0088 LLOYD'S REGISTER QUALITY ASSURANCE LTD (0088)
NB 0120 SGS United Kingdom Limited
NB 0359 INTERTEK TESTING & CERTIFICATION LTD
NB 0473 AMTAC CERTIFICATION SERVICES LTD
NB 0843 UL INTERNATIONAL (UK) LTD
Norway / Norge
NB 0434 DET NORSKE VERITAS CERTIFICATION AS
NB 0470 NEMKO AS
Switzerland
NB 1250 SCHWEIZERISCHE VEREINIGUNG FÜR QUALITÄTS- UND MANAGEMENTSYSTEME
NB 1251 SGS Société Générale de Surveillance AG
NB 1252 QS Schaffhausen AG
NB 1253 Swiss TS Technical Services AG
NB 1254 QS Zürich AG
Turkey
NB 1984 Meyer Uluslararası Uygunluk Değerlendirme Hizmetleri Limited Şirketi
NB 2179 KALITEST BELGELENDIRME VE EGITIM HIZMETLERI LTD. STI.
NB 2195 Szutest Teknik Kontrol ve Belgelendirme Hizmetleri Ticaret Limited Şirketi
(5 September 2007)
Article 16
Notified bodies
1. The Member States shall notify the Commission and other Member States of the bodies which they have designated for carrying out the tasks pertaining to the procedures referred to in Article 11 and the specific tasks for which the bodies have been designated. The Commission shall assign identification numbers to these bodies, hereinafter referred to as 'notified bodies'.
The Commission shall publish a list of the notified bodies, together with the identification numbers it has allocated to them and the tasks for which they have been notified, in the Official Journal of the European Communities. It shall ensure that the list is kept up to date.
2. Member States shall apply the criteria set out in Annex XI for the designation of bodies. Bodies that meet the criteria laid down in the national standards which transpose the relevant harmonized standards shall be presumed to meet the relevant criteria.
3. A Member State that has notified a body shall withdraw that notification if it finds that the body no longer meets the criteria referred to in paragraph 2. It shall immediately inform the other Member States and the Commission thereof.
4. The notified body and the manufacturer, or his authorized representative established in the Community, shall lay down, by common accord, the time limits for completion of the assessment and verification operations referred to in Annexes II to VI.
5. The notified body shall inform its competent authority about all certificates issued, modified, supplemented, suspended, withdrawn or refused and the other notified bodies within the scope of this Directive about certificates suspended, withdrawn or refused and, on request, about certificates issued. The notified body shall also make available, on request, all additional relevant information.
6. Where a notified body finds that pertinent requirements of this Directive have not been met or are no longer met by the manufacturer or where a certificate should not have been issued, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate issued or place any restrictions on it unless compliance with such requirements is ensured by the implementation of appropriate corrective measures by the manufacturer. In the case of suspension or withdrawal of the certificate or of any restriction placed on it or in cases where an intervention of the competent authority may become necessary, the notified body shall inform its competent authority thereof. The Member State shall inform the other Member States and the Commission.
7. The notified body shall, on request, supply all relevant information and documents including budgetary documents, required to enable the Member State to verify compliance with Annex XI requirements.
ANNEX XI
CRITERIA TO BE MET FOR THE DESIGNATION OF NOTIFIED BODIES
1. The notified body, its Director and the assessment and verification staff shall not be the designer, manufacturer, supplier, installer or user of the devices which they inspect, nor the authorized representative of any of these persons. They may not be directly involved in the design, construction, marketing or maintenance of the devices, nor represent the parties engaged in these activities. This in no way precludes the possibility of exchanges of technical information between the manufacturer and the body.
2. The notified body and its staff must carry out the assessment and verification operations with the highest degree of professional integrity and the requisite competence in the field of medical devices and must be free from all pressures and inducements, particularly financial, which might influence their judgment or the results of the inspection, especially from persons or groups of persons with an interest in the results of the verifications.
Should the notified body subcontract specific tasks connected with the establishment and verification of the facts, it must first ensure that the subcontractor meets the provisions of the Directive and, in particular, of this Annex. The notified body shall keep at the disposal of the national authorities the relevant documents assessing the subcontractor's qualifications and the work carried out by the subcontractor under this Directive.
3. The notified body must be able to carry out all the tasks assigned to such bodies by one of Annexes II to VI and for which it has been notified, whether these tasks are carried out by the body itself or on its responsibility. In particular, it must have the necessary staff and possess the facilities needed to perform properly the technical and administrative tasks entailed in assessment and verification. This presupposes the availability of sufficient scientific staff within the organisation who possess experience and knowledge sufficient to assess the medical functionality and performance of devices for which it has been notified, having regard to the requirements of this Directive and, in particular, those set out in Annex I. It must also have access to the equipment necessary for the verifications required.
4. The notified body must have:
- sound vocational training covering all the assessment and verification operations for which the body has been designated,
- satisfactory knowledge of the rules on the inspections which they carry out and adequate experience of such inspections,
- the ability required to draw up the certificates, records and reports to demonstrate that the inspections have been carried out.
5. The impartiality of the notified body must be guaranteed. Their remuneration must not depend on the number of inspections carried out, nor on the results of the inspections.
6. The body must take out civil liability insurance, unless liability is assumed by the State under domestic legislation or the Member State itself carries out the inspections directly.
7. The staff of the notified body are bound to observe professional secrecy with regard to all information gained in the course of their duties (except vis-à-vis the competent administrative authorities of the State in which their activities are carried out) pursuant to this Directive or any provision of national law putting it into effect.
