Article 15 (Notified Bodies) of the IVDD (98/79/EC) delineates the basic requirements governing the qualification of notified bodies within the European Union (EU). As the readers of Devine Guidance are all very much aware, the notified bodies are in a fairly precarious position. On one hand, they receive their authority from the Competent Authority located in the Member State in which the call home. However, on the other hand, they work for you, the device manufacturers. Remember, you pay them handsome sums of money for their support and the rental of their CE Mark. If you don’t believe Dr. D, just ask the finance person tasked with writing and signing the checks before they are mailed to your notified body.
1. 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 9 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.Member States shall not be obliged to designate a notified body.2. Member States shall apply the criteria set out in Annex IX 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. Member States shall apply continual surveillance of notified bodies to ensure ongoing compliance with the criteria set out in Annex IX. A Member State that has notified a body shall withdraw or restrict that notification if it finds that the body no longer meets the criteria referred to in Annex IX. It shall immediately inform the other Member States and the Commission of any withdrawal of notification or any restriction placed on it.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 III to VII.5. The notified body shall inform the other notified bodies and the competent authority about all certificates suspended or withdrawn and, on request, about certificates issued or refused. It 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 IX requirements.
- Do not fail to comply with the requirements delineated with the IVDD.
- Do not do a poor job in executing testing to establish compliance with essential requirements.
- Do not refuse to employ harmonized standards.
- Do not fail to maintain technical files and design dossiers in an ongoing state of compliance.
- Do not fail to retain adequate resources to support a compliant QMS.
- Do not fail in the application of an effective post-market surveillance system.
- Do not fail to file or investigate (root-cause please) vigilance reports.
- Do not wrongly affix a CE Mark to their product.
- Do not fail to remove a CE Mark when ordered to do so by your notified body.
- Do not fail to pay your notified body for services rendered (the doctor hopes this one is self-explanatory). If any of my friends from the network of notified bodies is reading this week’s DG, you are welcome.
- Devine, C. (2009, July). Exploring the effectiveness of defensive-receiving inspection for medical device manufacturers: a mixed method study. Published doctoral dissertation. Northcentral University. Prescott Valley, AZ.
- Devine, C. (2011). Devine Guidance series on complying with the MDD. Published in The Medical Device Summit.
- Directive 98/79/EC. (1998, October). Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices Retrieved September 12, 2011, from http://eur-lex.europa.eu.