Annex V (EC Declaration of Conformity – Production Quality Assurance) of Council Directive 93/42/EEC, a.k.a., the Medical Device Directive (MDD) delineates the requirements for device manufacturers and their need to employ an approved quality system in support of manufacturing and inspection. Wait a minute, having an approved-quality system is a fundamental requirement for entrance into the European device market? Who knew? I know – please stop being so darned facetious Dr. D!
One thing the doctor has learned from playing in the medical device industry sandbox is the variegated (look-it-up) interpretations of mandated regulations governing an already heavily regulated industry. At times, the MDD can be perceived as one of those propitious (look-it-up) pieces of regulation. Regardless, the MDD equates to law within the EU, and device manufacturers are required to comply with the MDD. Dr. D would like to reiterate DG Rule # 1 – Compliance to regulations is not optional, it is mandatory and dictated by law. That being said, Annex V is similar in construction to Annex II, minus the mention of the design component. Three of the salient components of Annex V, that will be discussed in this edition of DG, are: (a) device manufacturers must have an approved quality system; (b) device manufacturers must create and submit an EC Declaration of Conformity to their notified body; and (c) device manufacturers must affix the CE Marking, that reflects their notified body’s registration number to all product approved for importation and distribution within the EU.
Full text of MDD – 93/42/EEC ANNEX V (EC Declaration of Conformity – Production Quality Assurance) can be viewed here (see pages 42-44).
What you need to know
Let Dr. D start by reiterating three salient requirements depicting in the introduction. Broken-record time, device manufactures must have an approved quality system, an EC Declaration of Conformity signed by the Chief Jailable Officer (CJO), and CE Marks affixed to products, but wait there’s more (sounds like a commercial). A notified body does not just fall from the sky. Device manufacturers must go out and select one; and before the doctor forgets, this process costs money or should Dr. D say, “Euros.”
There are some extremely competent notified bodies out there. The doctor has worked with TUV-R, BSI, DEKRA, TUV-SUD, GMED, and NSAI (Dr. D is not a paid spokesperson for these firms). I recommend selecting one that has familiarity with your products and collectively, your organization is comfortable working with for the duration. This will be a long-term relationship so choose wisely. In fact, this will be a business marriage. By the way, did the doctor mention you must pay for this relationship?
Once the notified body has been selected, the device manufacturer must apply to the notified body for the quality system assessment. A few key components of the application process are:
- The application must contain the manufacturer’s name and address – duh;
- Relevant product information must be provided;
- A written declaration stating that multiple applications have not been filed with other notified bodies (only one application is permitted for each device marketed within the EU);
- Quality system documentation;
- Ongoing quality system maintenance;
- Technical documentation associated with EC type-examination certificates; and
- A system for executing post-market surveillance activities.
Additionally, the quality system must be capable of supporting manufacturing operations that result in products meeting their essential requirements, and the Directive, as depicted within the EC type-examination certificate. Some of the documentation that needs to be considered for inclusion into the overall approach to quality system management are; the quality policy statement, the quality manual, procedures, work instructions, quality programs, plans, and records. In turn, the documentation created must be capable of supporting the device manufacturer as a whole. Even though Annex V formally delineates the requirements under the title “quality system,” it is in reality a business management system. Not only should the quality system and the influence a well-designed system has on manufacturing be considered, the positive influence a quality system exudes on the entire organization should be the fundamental goal.
Furthermore, the quality system and the associated documentation, as a minimum, must adequately describe and include:
- The quality objectives;
- Organizational structure;
- Responsibilities and powers of management specific to product quality;
- Testing being performed;
- Traceability back to and calibration of test equipment;
- Methods employed for monitoring the quality system;
- Quality records and their fundamental management and retention;
- The qualifications of all personnel;
- Details associated with the final inspection, testing and acceptance of products; and
- The monitoring and specific requirements for third-parties employed for final inspection and testing of products.
Finally, it is up to the notified body to assess the device manufacturer’s quality system and ascertain if the system meets the requirements of the Directive. Remember, the goal is to have a fully implemented and approved quality system in accordance with EN ISO 13485:2003, elements of the MDD, and relevant harmonized standards, as applicable. The notified body is required to perform the assessment at the device manufacturer’s facility “duh,” with an assessment team that is trained and qualified. Upon completion of the assessment, the notified body will provide a written report containing observations, deviations, and conclusions. Deviations should be assigned, if warranted, prior to the departure of the assessment team.
Once the quality system has been approved and certified by the notified body, it is the responsibility of the device manufacturer to inform the notified body of all changes made to the quality system. In fact, during each annual assessment, one of the first questions the notified body will ask relates to changes made to the quality system since their previous visit. Hopefully, the answer is none, because notified bodies do not like surprises. By the way, did Dr. D mention notified bodies are paid by the device manufacturers to perform these assessments?
As Dr. D continues to age gracefully, so does my memory, or at least that is what the doctor would have the readers believe. In testing the doctor’s memory, a few DG editions ago, Dr. D mentioned that once a device manufacturer receives their certificate, reflecting a qualified quality system, the notified body does not just go away. As with other Annexes associated with the Directive, notified bodies are required to carry out inspections, as necessary, to ensure device manufacturers and their products remain in compliance with the Directive. Usually, the notified bodies plan these visits well in advance and provide an agenda for their visits (assessments). However, the notified bodies, under the Directive, have the authority to show up on a device manufacturer’s door step – unannounced. By the way, did Dr. D mention device manufacturers must pay their notified bodies for these visits?
Similar to previously discussed Annexes, manufacturers or their Authorized European Representative must retain and make available certificates and documentation for a period of five years or 15 years (for implantable devices), after the last device has been manufactured. As a minimum, the following pieces of data must be retained:
(a) declarations of conformity;
(b) documentation defining the quality system or changes made to the quality system;
(c) technical documentation (e.g., technical file);
(d) reports and associated correspondences received from the notified body; and
(e) EC type-examination certificates.
In testing the doctor’s memory again, the previous edition of DG contained a pointer to the inclusion and applicable of Class IIa devices as a salient element of Annex IV. Guess what? The same applicability clause for Class IIa devices is also a fundamental requirement for Annex V.
During each of the friendly visits made to a device manufacturer’s facility, by their notified body, for the purpose of performing an assessment will result in a review of technical files as well. Notified bodies are required, in accordance with the Directive, to pull a sample of technical files, from each product family to review. That is why it is so darned important to keep technical files up-to-date. If a device manufacturer is blowing the proverbial dust off the cover before their notified body’s assessment, they can expect to receive deviations as a result of the assessment. In fact, device manufacturers risk earning a major deviation as a result of the effort or should the doctor say, a lack of effort in maintaining technical files.
Not wanting to continue to sound like a broken record but obliged to do so because of the redundancy associated with several of the Annexes, products containing human-blood derivatives require additional testing. This testing must be performed at a State laboratory or an approved laboratory identified by a Member State. When in doubt, contact your notified body when testing is required. Hopefully, they will not charge you for just asking a question; but hey, these are difficult economic times.
What you need to do
For this edition of DG, doctor D will keep it simple, promise. Annex V, similar to all of the requirements delineated within the Directive, establishes basic expectations for device manufacturers and the responsibilities of notified bodies. That being said, the to do’s are really simple and self-explanatory:
- Establish a compliant quality system.
- Ensure the quality system is assessed and hopefully, approved by a notified body.
- Ensure the CJO signs the Declaration of Conformity.
- Ensure the finished medical device packaging contains a CE Mark.
- Ensure a post-market surveillance system is established.
- Ensure adverse events are reported to the Competent Authorities (a.k.a., Vigilance Reports).
- Remember notified bodies are required to perform annual assessments.
- Remember that notified bodies can appear on a device manufacturer’s door step unannounced.
- Remember to keep technical files current.
- Remember there is a mandated data retention requirement.
- Acknowledge the applicability component for Class IIa devices.
- Remember to employ approved laboratories for testing of products that contain human-blood derivatives.
I am sure by now; the readers are growing tired of the doctor’s takeaways premised on common sense and regulations. In reality, there is just one takeaway and one takeaway only. Medical device manufacturers must design, develop, manufacturer, inspect, test, inspect some more, label, package, affix a CE Mark, ship, and distribute “medical devices that are safe and effective – period!” Obviously, quality systems and compliance to all applicable regulations are fundamental requirements. However, if a device manufacturer cannot “make medical devices that are safe and effective,” well what’s the point?
Until the next installment of DG, when Dr. D will begin providing guidance for complying with Annex VI (EC Declaration of Conformity – Product Quality Assurance) 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.
- EN ISO 13485:2003. (2004, February). Medical devices – quality management systems – requirements for regulatory purposes (ISO 13485:2003).