Annex VI (EC Declaration of Conformity – Product Quality Assurance) of Council Directive 93/42/EEC, a.k.a., the Medical Device Directive (MDD) delineates the requirements for the performance of the quality system and specifically final inspection and testing of product. There is significant redundancy built into the Directive and the Annexes, and Dr. D is sure that readers understand the application of the Annexes and their applicability for Class IIa, Class IIb, and Class III products, and the importance of making the correct reference to applicable Annexes in the signed EC Declaration of Conformity.

Additionally, the doctor hopes that by now readers understand the significance of ensuring medical devices meet their essential requirements prior to having the Chief Jailable Officer (CJO) affixing his or her signature to the declaration, and the duties and responsibilities of the notified bodies and Competent Authorities, as prescribed within the Directive. The doctor also hopes that by now the readers understand the importance of affixing the CE mark onto approved products and the ramifications of wrongly affixing CE marks to products.

Although Dr. D does not consider himself to be overly prophetic, I can offer multiple vaticinations (look-it-up) when device manufacturers fail to comply with the MDD. Can you say market withdraw a.k.a., “RECALL” – Dr. D’s favorite six-letter word? Can you say the revenue stream has just been interrupted?

That being said, the doctor promises not to bore the readers with guidance that is redundant from the previous few weeks. Instead, Dr. D will climb onto his soap box and dance (just kidding). One of the neighborhood kids actually stole my soap box and used the wood for skateboards, so I will just write and be brief.

Full text of MDD – 93/42/EEC ANNEX VI (EC Declaration of Conformity– Product Quality Assurance) can be viewed here (pages 45-47). 

What you need to know
Dr. D realizes the broken-record approach to teaching and providing guidance for regulations can be extremely boring. However, there is some value in the repetitive approach to learning. In the Marine Corps, we called the repetitive approach learning through pain. In the medical device industry, the same approach can be called proactive learning. Regardless, the bulleted points depicted in this section capture what device manufacturers need to know and understand in regards to Annex VI; and yes, some of these points are redundant.

1. Device manufactures must establish an approved Quality Management System (QMS) to support the final inspection and testing of product.
2. A signed Declaration of Conformity is a salient requirement of Annex VI.
3. A CE Marking of conformity, containing the registration number of the device manufacturer’s notified body, is a salient requirement of Annex VI.
4. The notified body is required to review and approve the device manufacturer’s QMS.
5. The device manufacturer is required to monitor and maintain an effective QMS.
6. Device manufacturers are required to institute a post-market surveillance program.
7. Device manufacturers are required to notify the Competent Authorities when adverse events occur (vigilance reporting).
8. Device manufacturers are required to maintain quality records.
9. Notified bodies are required to perform surveillance audits after initial approval of a device manufacturer’s QMS.
10. Device manufacturers are required to keep records specific to the Directive and certifications for a period of five years or 15-years (implantable devices).

What you need to do
First and foremost, device manufacturers need to develop and implement a world-class QMS that is fully compliant with ISO 13485:2003. Establishing an effective QMS, regardless of the cost, should be considered the basic price of admission into the European device market.

Second, really put some significant effort into finding a competent notified body that your organization can work with effectively. I know Dr. D has made ongoing jokes about paying the notified bodies; however, they do work for the device manufacturer.

Third, when tossing an M61 fragmentation grenade, accuracy is not a factor providing the grenade is thrown in the direction of the bad guys. In medical devices, accuracy always counts, especially with the information placed in the declarations and certificates. Device manufacturers must ensure the declaration is complete and accurate prior to having the CJO affixing his or her signature.

Fourth, placing a CE mark on the product is extremely important. Make sure all of the applicable approvals and certifications have been received prior to affixing CE marks to the outer-most packaging of the finished medical device. If a device manufacturer has multiple notified bodies, please ensure the right CE mark is placed onto the correct product. Sounds like a pretty simple concept, right? The doctor has seen device manufacturers’ royally screw up the placement of the CE mark by putting the wrong mark on the wrong product. Can you say “RECALL?”

Fifth, device manufacturers need to ensure technical files, and design dossiers are maintained to current standards; and the QMS monitored for ongoing effectiveness. Why? Because the notified bodies are required to perform annual visits, as a minimum. They also retain the authority to show up unannounced. Remember, device manufacturers are paying the notified bodies for this oversight.

Finally, record retention should always be considered a mission-critical requirement. Granted, the five and 15-year requirement delineated within the directive is a given; however, all of the other records count too. Device manufacturers should establish an effective record retention procedure that delineates: (a) types of records; (b) record storage; (c) record retention duration; (d) protection from deterioration; and (e) audit requirements if records are stored at a third-party storage facility; e.g. Iron Mountain.

Takeaways
For device manufacturers, it all starts with the QMS. For device manufacturers, it all starts with the QMS. For device manufacturers, it all starts with the QMS. The repetitive learning process – got it? From Dr. D’s perspective, the QMS should be premised on ISO 13485:2003. Regardless of the functional area; design, test, manufacturing, inspection, packaging, labeling, distribution, post-market surveillance, etc., it all starts with the QMS. All aspects of a device manufacturer’s business must be controlled by established procedures. If the QMS is well-defined and employees are trained and performing tasks in accordance with documented procedures, then meeting the regulatory requirements of Annex VI and the Directive, as a whole, should be the proverbial “cake walk.” 

Until the next installment of DG, when Dr. D will begin providing guidance for complying with Annex VII (EC Declaration of Conformity) of Council Directive 93/42/EEC, the MDD – cheers from Dr. D and best wishes for continued professional success.

References:

1. 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
2. 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.
3. EN ISO 13485:2003. (2004, February). Medical devices – quality management  systems – requirements for regulatory purposes (ISO 13485:2003).