Article 11, of Council Directive 93/42/EEC, a.k.a., the Medical Device Directive (MDD) delineates the requirements for “Conformity Assessment Procedures.” Simply put, Article 11 aligns the actual classification of devices with the applicable Annex in order to affix a CE mark containing the notified body’s registration number. Understanding the importance of device classification and the selection of the appropriate Annexes is mission critical for device manufacturers and a crucial step as they walk down the path toward conformity. That is why selecting a competent notified body is important, even though some notified bodies believe they are the omphalos (look-it up) of the medical device industry in the European Union (EU).
That said it is important for device manufacturers to comprehend terms such as “EC type-examination,” “EC declaration of conformity,” and “EC verification,” along with the importance of Annex II through Annex VIII. In simplifying the MDD requirement, Dr. D recommends committing one thought to memory; “There will not be any CE mark affixation without a conformity assessment, and without the CE mark, there will be no product entry into the EU.” In fact, it does not take special powers to make the presentiment (look-it up) that something bad will happen when device manufacturers attempt to enter product into commerce, in the EU, without a CE mark. Pretty simple concept, right?
The MDD – 93/42/EEC
Article 11 – Conformity Assessment
1. In the case of devices falling within Class III, other than devices which are custom-made or intended for clinical investigations, the manufacturer shall, in order to affix the CE marking, either:
(a) follow the procedure relating to the EC declaration of conformity setout in Annex II (full quality assurance); or
(b) follow the procedure relating to the EC type-examination setout in Annex III, coupled with: (i) the procedure relating to the EC verification setout in Annex IV; or (ii) the procedure relating to the EC declaration of conformity set out in Annex V (production quality assurance).
2. In the case of devices falling within Class IIa, other than devices which are custom-made or intended for clinical investigations, the manufacturer shall, in order to affix the CE marking, follow the procedure relating to the EC declaration of conformity setout in Annex VII, coupled with either:
(a) the procedure relating to the EC verification setout in Annex IV; or
(b) the procedure relating to the EC declaration of conformity setout in Annex V (production quality assurance); or
(c) the procedure relating to the EC declaration of conformity setout in Annex VI (product quality assurance). Instead of applying these procedures, the manufacturer may also follow the procedure referred to in paragraph 3 (a).
3. In the case of devices falling within Class IIb, other than devices which are custom-made or intended for clinical investigations, the manufacturer shall, in order to affix the CE marking, either:
(a) follow the procedure relating to the EC declaration of conformity setout in Annex II (full quality assurance); in this case, point 4 of Annex II is not applicable; or
(b) follow the procedure relating to the EC type-examination setout in Annex III, coupled with:
(i) the procedure relating to the EC verification setout in Annex IV; or
(ii) the procedure relating to the EC declaration of conformity set out in Annex V (production quality assurance); or
(iii) the procedure relating to the EC declaration of conformity set out in Annex VI (product quality assurance).
4. The Commission shall, no later than five years from the date of implementation of this Directive, submit a report to the Council on the operation of the provisions referred to in Article 10 (1), Article 15 (1), in particular in respect of Class I and Class IIa devices, and on the operation of the provisions referred to in Annex II, Section 4.3 second and third subparagraphs and in Annex III, Section 5 second and third subparagraphs to this Directive, accompanied, if necessary, by appropriate proposals.
5. In the case of devices falling within Class I, other than devices which are custom-made or intended for clinical investigations, the manufacturer shall, in order to affix the CE marking, follow the procedure referred to in Annex VII and draw up the EC declaration of conformity required before placing the device on the market.
6. In the case of custom-made devices, the manufacturer shall follow the procedure referred to in Annex VIII and draw up the statement set out in that Annex before placing each device on the market. Member States may require that the manufacturer shall submit to the competent authority a list of such devices which have been put into service in their territory.
7. During the conformity assessment procedure for a device, the manufacturer and/or 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 stage of manufacture.
8. The manufacturer may instruct his authorized representative to initiate the procedures provided for in Annexes III, IV, VII and VIII.
9. Where the conformity assessment procedure involves the intervention of a notified body, the manufacturer, or his authorized representative, may apply to a body of his choice within the framework of the tasks for which the body has been notified.
10. 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.
11. Decisions taken by the notified bodies in accordance with Annexes II, III, V and VI shall be 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 a maximum length of five years.
12. The records and correspondence relating to the procedures referred to in paragraphs 1 to 6 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.
13. By derogation from paragraphs 1 to 6, 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 6 have not been carried out and the use of which is in the interest of protection of health.
14. The measures designed to amend non-essential elements of this Directive by supplementing it, relating to the means by which, in the light of technical progress and considering the intended users of the devices concerned, the information laid down in Annex I Section 13.1 may be set out, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).
What you need to know
As stated in the opening paragraph, device manufacturers need to know and understand the link between device classification and appropriate Annex. Approval of the Technical Files for Class I, IIa, and IIb devices or the Design Dossiers for Class III devices, and the appropriate certificates issued by the notified body, including the manufacturer’s signed Declaration of Conformity (DoC), will delineate the path of conformity within each document. This specifically includes the applicable Annexes. Your notified body can lead you through the process.
Additionally, once the application for your device has been approved, and in accordance with the Directive, the application will remain valid for a period of up to five years. Your notified body has the right to issue a five-year extension; however, such extensions are a rare event indeed. Why? Because notified bodies make significant coin in performing these reviews. Furthermore, the Competent Authority has the power and authority to permit entry of devices into their Member State, when device manufacturers have failed to meet paragraphs 1 through 6 of Article 11. Although this is also a rare event, sometimes such decisions are in the best interest of protecting the public’s health.
What you need to do
Device manufacturers need to continue with their weekly dose of Devine Guidance and the MedicalDeviceSummit, while remembering Dr. D will never steer the readers in the wrong direction (at least not intentionally).
All kidding aside, understanding the link between device classification and the applicable Annexes should be considered mission critical, I know Dr. D sounds like a broken record or should I say CD. Another point the doctor would like to make is in regards to Class III devices. Your notified body will perform and in-depth review of your application and the Design Dossier prior to issuing an approval and the appropriate certificates. Be prepared for several rounds of questions, premised on the notified body, especially if this is a new application. Depending on the notified body, the length of approval will be from three to five years. If during this time period, the specific device has an impeccable performance record (safe and effective); and there is no history of serious injury or death, you can always ask your notified body for an extension. All Dr. D can say is, “good luck with the request;” however, it is a device manufacturer’s right to ask.
Years ago, Class I and II devices were typically approved through a path of self-certification; however, notified body are now reviewing Technical Files with the same rigor employed with Design Dossiers. In fact, the notified bodies, under changes to the MDD that were made in 2010, are now required to perform a mandatory review of Technical Files during their annual audit. The sample size of Technical Files reviewed has also increased substantially. The moral of the story here is quite simple; “Technical Files should be managed and sustained accordingly to ensure they are always in a state of compliance.”
Finally, and the doctor cannot emphasize this point enough, device manufacturers should select a notified body they are comfortable working with, for a very long period of time. The relationship between the manufacturer and notified body is very similar to a marriage, except the device manufacturer is paying for the pain (just kidding). Seriously, the doctor has been involved in switching to a new notified body when dozens of device were involved. Folks, it is an expensive proposition to change notified bodies. The application and reviews are the easy part, the labeling changes to incorporate the new CE mark is costly.
In the eyes of Dr. D, there are three important takeaways from this week’s guidance.
- Broken-record time – device manufacturers need to understand the link between device classification and the appropriate Annexes.
- Notified bodies are permitted to grant application extensions for up to five years.
- The Competent Authority, for a member state, has the authority to grant device entry even if compliance to paragraphs 1 through 6 of Article 11 has not been achieved.
Until the next installment of DG, when Dr. D will provide guidance for complying with Article 12 (Particular Procedure for Systems and Procedure Packs and Procedure for Sterilization) of Council Directive 93/42/EEC, the MDD – 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.