Article 9 (Conformity Assessment Procedures) of the IVDD (98/79/EC), delineates the path for conformity IVD medical devices must comply with in order for the CE Marking of conformity to be legally affixed to the device packaging. In short, Article 9 is kind of like a road map that device manufacturers must follow in their pursuit of entering an IVD medical device into the European market.
The good news is that unlike your Tom-Tom or similar GPS devices that require ongoing updates to ensure the maps are current, the IVDD does not change frequently. However, when changes to the Directive are made, they are usually big ones, that are typically punctuated with onomatopoeia (look-it-up) of sounds similar to a bam, boom, or crash, used to announce the arrival of the changes. While reading the contents of Article 9, it is easy to get lost in all of the pointers to the Annexes and regulatory legalese. That being said, Dr. D will guide you through Article 9 of the IVDD and provide the readers with a fundamental understanding of the requirement and what is necessary for compliance.
The IVDD – 98/79/EC
Article 9 – Conformity Assessment Procedures
1. For all devices other than those covered by Annex II and devices for performance evaluation, the manufacturer shall, in order to affix the CE marking, follow the procedure referred to in Annex III and draw up the EC declaration of conformity required before placing the devices on the market.For all devices for self-testing other than those covered by Annex II and devices for performance evaluation, the manufacturer shall, prior to the drawing up of the aforementioned declaration of conformity, fulfill the supplementary requirements set out in Annex III, point 6. Instead of applying this procedure, the manufacturer may follow the procedure referred to in paragraphs 2 or 3.2. For all devices referred to in List A in Annex II other than those intended for performance evaluation, the manufacturer shall, in order to affix the CE marking either:
(a) follow the procedure relating to the EC declaration of conformity set out in Annex IV (full quality assurance), or(b) follow the procedure relating to EC type-examination set out in Annex V coupled with the procedure relating to the EC declaration of conformity set out in Annex VII (production quality assurance).
3. For all devices referred to in List B in Annex II other than those intended for performance evaluation, the manufacturer shall for the purposes of affixing the CE marking, follow either:
(a) the procedure relating to the EC declaration of conformity set out in Annex IV (full quality assurance) or(b) the procedure relating to EC type-examination set out in Annex V couplet with:
(i) the procedure relating to EC verification set out in Annex VI, or(ii) the procedure relating to the EC declaration of conformity set out in Annex VII (production quality assurance).
4. In the case of devices for performance evaluation, the manufacturer shall follow the procedure referred to in Annex VIII and draw up the statement set out in that Annex before such devices are made available.This provision does not affect national regulations relating to the ethical aspects of carrying out performance evaluation studies using tissues or substances of human origin.5. During the conformity assessment procedure for a device, the manufacturer and, if involved, the notified body shall take account of the results of any assessment and verification operations which, where appropriate, have been carried out in accordance with this Directive at an intermediate state of manufacture.6. The manufacturer may instruct his authorized representative to initiate the procedures provided for in Annexes III, V, VI and VIII.7. The manufacturer must keep the declaration of conformity, the technical documentation referred to in Annexes III to VIII, as well as the decisions, reports and certificates, established by notified bodies, and make it available to the national authorities for inspection purposes for a period ending five years after the last product has been manufactured. Where the manufacturer is not established in the Community, the obligation to make the aforementioned documentation available on request applies to his authorized representative.8. Where the conformity assessment procedure involves intervention of a notified body, the manufacturer, or authorized representative, may apply to a body of his choice within the framework of tasks for which the body has been notified.9. The notified body may require, where duly justified, any information or data, which is necessary for establishing and maintaining the attestation of conformity in view of the chosen procedure.10. Decisions taken by the notified bodies in accordance with Annexes III, IV, and V shallbe valid for a maximum of five years and may be extended on application, made at a time agreed in the contract signed by both parties, for further periods of up to five years.11. The records and correspondence relating to the procedures referred to in paragraphs 1 to 4 shall be in an official language of the Member State in which the procedures are carried out and/or in another Community language acceptable to the notified body.12. By way of derogation from paragraphs 1 to 4, the competent authorities may authorize, on duly justified request, the placing on the market and putting into service, within the territory of the Member State concerned, of individual devices for which the procedures referred to in paragraphs 1 to 4 have not been carried out and the use of which is in the interest of protection of health.13. The provisions of this Article shall apply accordingly to any natural or legal person who manufacturers devices covered by this Directive and, without placing them on the market, puts them into service and uses them in the context of his professional activity.
What IVD medical device manufacturers need to know
The first salient concept IVD medical device manufacturers need to know and understand, pertains to Article 9 and (a) the importance of the link between Annex II (List of Devices Referred to in Article 9 (2) and (3)); and (b) the pointers to List A and List B devices, as well as Annex III (EC Declaration of Conformity) for all other devices.
Before a device manufacturer can proceed with testing and certification, it is critical to ensure that IVD medical devices are classified correctly. When in doubt, contact your notified body. Once the correct device classification has been established, follow Article 9 and employ the appropriate Annexes. Remember, device manufacturers cannot pick and choose the Annexes with which they wish to or want to comply; they must adhere to Article 9, period! Article 9 delineates the applicable Annexes that are required for compliance. In simplifying the selection process, device manufacturers should be ready to comply with Annex III; Annex IV (EC Declaration of Conformity – Full Quality System); Annex V (EC Type-Examination); Annex VI (EC Verification); Annex VII (EC Declaration of Conformity – Production Quality Assurance); Annex VIII (Statement and Procedures Concerning Devices for Performance Evaluation; or any combination of the above, dependent upon device classification.
Additional salient points IVD medical device manufactures should know and understand are:
- Devices depicted under List A and List B will require the affixing of a CE Mark, prior to their entry into the European market. Similar to the MDD, device manufacturers will be required to prove compliance with essential requirements.
- Depending on the device classification, a design dossier or technical file will need to be prepared to support the device application process, including a Declaration of Conformity (DoC) signed by the Chief Jailable Office (CJO).
- Devices entering the EU for evaluation purposes must still comply with Annex VIII. Remember, this requirement does not trump a Member State’s right to ensure ethical practices are employed when pursing an evaluation using tissues or other substances of human origin. A simple way to remember this requirement is by memorizing one of the doctor’s rhymes; “If a Member State says no, the device must go,” yes, Dr. D knows it sounds like something the late Johnny Cochrane might say.
- In complying with Article 9, Member States retain the right to receive records and documentation, associated with paragraphs one (1) through four (4) in their native tongue, unless they have agreed to utilize the community language instead. So much for the use of English as a recognized international language.
- Device manufacturers and/or the European Authorized Representative are free to select a notified body of their own choosing.
- The Competent Authorities may authorize the placement of an IVD medical device within a Member State(s), upon request, when paragraphs one (1) through four (4) have not been achieved.
- Once application approval has been received from the notified body, the certification is issued and remains valid for a period not to exceed five (5) years. The notified bodies also retain the right to extend the application / certification for an additional five-year period. However, Dr. D’s experience is that extensions are rare events indeed. Why? Because notified bodies make money performing recertification application reviews.
- Finally, hold on to that DoC, Technical File, Design Dossier, Design Examination Certificate, Quality System Certificate, and all other relevant documentation for at least 5-years. Why? Because you never know when the Competent Authorities might want to have a looksee, besides, its required under paragraph seven (7) of Article 9.
What IVD medical device manufacturers need to do
Dr. D would like to emphatically state, “The IVD device application processes begins with the selection of the correct classification of the device under Annex II.” Employing the doctor’s fondness for sounding like a broken record, device manufacturers should always consult with their notified body prior to proceeding. The interpretation of what constitutes a List A versus a List B device is too important to just wing it. On the positive side, device manufacturers already having an approved Quality Management System (QMS) and devices approved under the MDD (93/42/EEC) should have an easier time navigating through the requirements delineated within the IVDD. That being said, a few key items IVD medical device manufacturers need to do are:
- Ensure application approval and certificates are received prior to affixing the CE Mark.
- Ensure devices always conform to their essential requirements; hopefully, harmonized standards and common technical specifications.
- Devices not conforming to paragraphs one (1) through four (4) of Article 9 can still make their way into a Member State for evaluation testing, provided compliance with Annex VIII is achieved.
- When required by a Member State, ensure the native language requirement is met. Remember, the French might not be overly excited about receiving correspondences in American English.
- As a minimum, keep records for a five-year period, after the last device has been manufactured and shipped (do not forget to add shelf-life into the equation).
- Do not be afraid to ask your notified body for an application extension (good luck with the request).
- Once the DoC is created, ensure the CJO affixes his or her signature to the bottom of the document. Ensure to ask the CJO if they look good in an orange jumpsuit, prior to obtaining their signature.
- Always ensure technical documentation is kept current. Technical Files and Design Dossiers should be considered dynamic documents. When a standard changes, the impact of the change and influence the change has on a device must be considered. If necessary, testing to the revised standard needs to be pursued.
Takeaways
Understanding the significance of Article 9 and correctly classifying a device in regards to List A or List B will drive the entire qualification process by identifying the appropriate Annexes needed to support the testing and application of IVD medical devices. Similar to the MDD, the IVDD is all about establishing compliance with essential requirements.
Until the next installment of DG, when Dr. D provides insight and guidance into complying with Article 10 (Registration of Manufacturers and Devices) 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 90/385/EEC. (1990, June). Council Directive 90/385/EEC on the approximation of the laws of Member States relating to active implantable medical devices. Retrieved November 15, 2011, from http://eur-lex.europa.eu
- 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 series on complying with the MDD. Published in The Medical Device Summit.
- Directive 98/34/EC. (1998, June). Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 – laying down a procedure for the provision in the field of technical standards and regulations and of rules on information society services. Retrieved November 15, 2011, from http://eur-lex.europa.eu
- 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.
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