NOTIFIED BODIES: ACTIVE IMPLANTABLE MEDICAL DEVICES 90/385/EEC

 Ceska Republika / Czech Republic

NB 1014 ELEKTROTECHNICKÝ ZKUŠEBNÍ ÚSTAV, s.p.

NB 1023 INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s.

   Deutschland / Germany

NB 0044 TÜV NORD CERT GmbH             

NB 0123 TÜV SÜD Product Service GmbH  

NB 0197 TÜV Rheinland LGA Products GmbH   

NB 0482 MEDCERT ZERTIFIZIERUNGS- UND PRÜFUNGSGESELLSCHAFT FÜR DIE MEDIZIN GMBH

NB 0535 EUROCAT - INSTITUTE FOR CERTIFICATION AND TESTING GMBH 

NB 1275 LGA INTERCERT ZERTIFIZIERUNGSGESELLSCHAFT MBH    

  Ireland / Eire

NB 0050 National Standards Authority of Ireland (NSAI)

  España / Spain

NB 0318 AGENCIA ESPAÑOLA DE MEDICAMENTOS Y PRODUCTOS SANITARIOS

  France

NB 0459 Laboratoire national d'essais / G-MED

 Italia / Italy

NB 0373 ISTITUTO SUPERIORE DI SANITA

 Magyarorzag / Hungary

NB 1011 ORVOS- ÉS KÓRHÁZTECHNIKAI INTÉZET (ORKI) (INSTIT. FOR MEDICAL AND HOSPITAL ENGIN.)

 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.

   Slovenska Republika / Slovakia

NB 1293 EVPU a.s.

  United Kingdom

NB 0086 BSI

Council Directive 90/385/EEC

(5 September 2007)

Article 11

1.  Member States shall notify the Commission and the other Member State of the bodies which they have appointed to carry out the procedures referred to in Article 9 together with the specific tasks which these bodies have been appointed to carry out and the identification numbers assigned to them beforehand by the Commission.

The Commission shall publish in the Official Journal of the European Communities a list of the notified bodies and their identification numbers and the tasks for which they have been notified. The Commission shall ensure that this list is kept up to date.

2.  Member States shall apply the minimum criteria, set out in Annex 8, for the designation of bodies. Bodies that satisfy the criteria fixed by the relevant harmonized standards shall be presumed to satisfy the relevant minimum criteria.

When appropriate in the light of technical progress, the detailed measures necessary to ensure a consistent application of the criteria set out in Annex 8 to this Directive for the designation of bodies by the Member States shall be adopted in accordance with the regulatory procedure referred to in Article 6(3).

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 authorised representative  shall fix, by common accord, the time limits for completion of the evaluation and verification operations referred to in Annexes 2 to 5.

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 that 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 the criteria laid down in Annex 8.

ANNEX 8

MINIMUM CRITERIA TO BE MET WHEN DESIGNATING INSPECTION BODIES TO BE NOTIFIED

1. The body, its director and the staff responsible for carrying out the evaluation and verification operations shall not be the designer, manufacturer, supplier or installer of devices which they control, nor the authorized representative of any of those parties. They may not become directly involved in the design, construction, marketing or maintenance of the devices, nor represent the parties engaged in these activities. This does not preclude the possibility of exchanges of technical information between the manufacturer and the body.

2. The body and its staff must carry out the evaluation and verification operations with the highest degree of professional integrity and technical competence and must be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of the inspection, especially from persons or groups of persons with an interest in the results of verifications.

3. The body must be able to carry out all the tasks in one of Annexes 2 to 5 assigned to such a body and for which it has been notified, whether those tasks are carried out by the body itself or under its responsibility. In particular, it must have at its disposal the necessary staff and possess the necessary facilities to enable it to perform properly the technical and administrative tasks connected with evaluation and verification; it must also have access to the equipment necessary for the verifications required.

4. The staff responsible for control operations must have:

• sound vocational training covering all the evaluation and verification operations for which the body has been designated,
• satisfactory knowledge of the requirements of the controls they carry out and adequate experience of such operations,
• the ability required to draw up the certificates, records and reports to demonstrate that the controls have been carried out.

5. The impartiality of inspection staff must be guaranteed. Their remuneration must not depend on the number of controls carried out, nor on the results of such controls.

6. The body must take out liability insurance unless liability is assumed by the State in accordance with national law, or the Member State itself is directly responsible for controls.

7. The staff of the body are bound to observe professional secrecy with regard to all information gained in carrying out their tasks (except vis-à-vis the competent administrative authorities of the State in which their activities are carried out) under this Directive or any provision of national law giving effect to it.