1. For devices for performance evaluation the manufacturer or his authorized representative shall draw up the statement containing the information stipulated in section 2 and ensure that the relevant provisions of this Directive are met.2. The statement shall contain the following information:
— data allowing identification of the device in question,— an evaluation plan stating in particular the purpose, scientific, technical or medical grounds, scope of the evaluation and number of devices concerned,— the list of laboratories or other institutions taking part in the evaluation study,— the starting date and scheduled duration for the evaluations and, in the case of devices for self-testing, the location and number of lay persons involved,— a statement that the device in question conforms to the requirements of the Directive, apart from the aspects covered by the evaluation and apart from those specifically itemized in the statement, and that every precaution has been taken to protect the health and safety of the patient, user and other persons.
3. The manufacturer shall also undertake to keep available for the competent national authorities the documentation allowing an understanding of the design, manufacture and performances of the product, including the expected performances, so as to allow assessment of conformity with the requirements of this Directive. This documentation must be kept for a period ending at least five years after the end of the performance evaluation.The manufacturer shall take all the measures necessary for the manufacturing process to ensure that the products manufactured conform to the documentation mentioned in the first paragraph.4. The provisions of Article 10(1), (3) and (5) shall apply to devices intended for performance evaluation.
- Data supporting device identification;
- An evaluation (study) plan specific to the device(s);
- A compiled list of facilities participating in the evaluation study;
- The planned start date of the study and the expected duration of the study; and
- A statement delineating device compliance to the requirements of the IVDD, including a precautionary statement pertaining to the safety and efficacy of the device, including the accuracy and repeatability of the results.
Remember, device manufacturers may be paying their notified bodies for their services, but the notified bodies receive their power from the Competent Authority located in the Member States in which they reside. So if the Competent Authorities are not happy, Dr. D is quite sure the notified bodies are not happy. When the notified bodies are not happy, they ask manufacturers of bad devices to stop shipping and remove the CE mark from their products. Do not be that device manufacturer that makes Competent Authorities and their notified body unhappy.
- Make sure statements created in support of Annex VIII are accurate and signed by your Chief Jailable Officer (CJO).
- Make sure all documentation associated with studies pursued is retained for a period of five years; and made available to the Competent Authorities upon request.
- Make sure all production processes are well documented and validated.
Until the next installment of DG, when Dr. D provides insight and guidance into complying with Annex IX (Criteria for Designation of Notified Bodies) of the In Vitro Diagnostic Medical Device Directive, a.k.a., IVDD – cheers from Dr. D and best wishes for continued professional success.
- Council Directive 93/42/EEC. (1993, June). Council Directive 93/42/EEC concerning medical devices. Retrieved December 21, 2010, from http://eur-lex.europa.eu
- 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 for complying with the European medical device directive – MDD. Charleston, SC: Amazon.
- Devine, C. (2012). Devine Guidance series on complying with the IVDD. 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
- EN ISO 13485:2003. (2004, February). Medical devices – quality management systems – requirements for regulatory purposes (ISO 13485:2003).