Annex VIII (Statement and Procedures Concerning Devices for Performance Evaluation) of the IVDD reiterates a device manufacturer’s commitment to supplying a device capable of providing accurate and repeatable results and ongoing compliance with the Directive. There are two salient concepts associated with Annex VIII. The first one is the creation of a statement by the device manufacturer or their European authorized representative containing relevant device test and evaluation information, plus conformance to the IVDD. The second one is maintaining device-specific data, and making the data available to the Competent Authorities (upon request) for a period of five years, after the end of the performance evaluation. The good news is that Dr. D believes the concepts associated with Annex VIII are not nearly as abstruse (look-it-up) as previously discussed Annexes. Enjoy.
The IVDD – 98/79/EC
Annex VIII – Statement and Procedures Concerning Devices for Performance Evaluation
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.
What IVDD medical device manufacturers need to know
If one has not figured out by now that the device industry is all about killing trees, well, now you know. Annex VIII requires device manufacturers or their EU authorized rep to create a statement containing specific pieces of information in support of providing proof of compliance to the IVDD. As a minimum, the following pieces of information are required in support of Annex VIII:
- 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.
As stated in the introduction, there is a data retention requirement. Device manufacturers are required to retain study-related data for a period of 5-years. The retention period commences upon completion of the study. If for some reason a competent authority requests device or study information, the device manufacturer is required, by EU law, to provide the requested information. The good news is that if your devices are not racking up vigilance reports, then the probability of such requests coming from a competent authority are low. However, if an IVDD is deemed not be safe and effective or capable of providing accurate and repeatable result, all bets are off.
Finally (a salient requirement of EN ISO 13485:2003), ensure manufacturing processes are properly validated. Although Annex VIII does not spell it out, the expectation is that device manufacturers establish manufacturing processes capable of producing devices that are safe and effective in their intended use, or in the case of an IVDD, capable of providing accurate and repeatable results.
What IVDD medical device manufacturers need to do
Similar to all of the aspects associated with this Directive and the other two Device Directives, it is all about the creation, collection, presentation, and retention of documentation and data. That sure is a whole lot of “ions.” In a perfect world, chances are device manufacturers will have just limited contact with the Competent Authorities. Trust Dr. D when I say that is not necessarily a bad thing. However, for device manufacturers that introduce a less than stellar product into commerce within the EU, all bets are off. When a Competent Authority picks up the phone and asks a notified body and the device manufacturer for supporting documentation, i.e., technical file, design dossier, specific test reports, certificates, etc. they want the information NOW! Not unlike those friendly USMC drill instructors living in the sub-tropical paradise of Parris Island South Carolina, when the notified body asks a device manufacturer to jump, the answer should be how high.
The doctor always recommends that device manufacturers have a stand-alone SOP for record retention. Although this Directive depicts a record retention period of five years, other Directives have a requirement of 15 years. Just a quick note, the FDA (21 CFR, Part 820) delineates a two-year requirement, so make sure an SOP created for record retention can meet multiple regulatory requirements for retention periods. Finally, (broken-record time) compliance to this Directive and establishing conformance to essential requirements is a sure-fire way to win the hearts and minds of the Competent Authorities. Trust the doctor when I say; “Shipping bad devices into the EU will lead to an equally bad experience with the Competent Authorities.”
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.
Takeaways
For this edition of DG, the doctor will leave the readers with three takeaways:
- 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.
References:
- 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).
Related Articles
-
The guidance is intended to clarify the FDA’s approach for referencing the terms “device” and “counterfeit device” in FDA documents, as well as how the agency intends to interpret existing references to section 201(h) of the FD&C Act in guidance,…
-
The new guidance is intended to establish confidence in automation used for production or quality assurance systems and describe various methods and testing activities that may be applied to establish computer software assurance and meet regulatory software validation requirements.
-
The updated guidance document clarifies what constitutes a statement of the basis for the deficiency and includes examples of well-constructed deficiencies and industry responses to facilitate a more efficient review process.
-
The revised cybersecurity draft publication is not intended to be a checklist for healthcare organizations to follow, but rather a guide to help them comply with the HIPAA Security Rule.
