Annex VII (EC Declaration of Conformity) of Council Directive 93/42/EEC, a.k.a., the Medical Device Directive (MDD) is all about the Declaration of Conformity. Surprised? For the frequent readers of Devine Guidance (DG), especially of late, Dr. D is pretty sure you have comprehended the significance the MDD places on that tiny piece of paper called the EC Declaration of Conformity (DoC). I guess killing trees in pursuit of compliance is acceptable; although I am sure the ISO 14001 pundits might hold different beliefs. For those readers not having a chance to read the previous six DG articles pertaining to the MDD Annexes; now would be a good time to catch up.
So doctor, tell me why the DoC is so darned important? Not wanting to state the obvious, but obliged to do so, the DoC is a requirement mandated by the MDD and not an optional “nice-to-have.” The information contained within the DoC is very specific in regards to device classification, applicable Annexes, part numbers, date approved, first lot shipped etc. Remember, the notified bodies employ this documentation, in part, to keep track of devices they approved for entry into the EU. The notified bodies will not give permission to affix their CE marking of conformity until the technical file or design dossier has been reviewed, approved, and a declaration signed by the Chief Jailable Office (CJO) received.
Additionally, if a device firm is racking up the vigilance reports in the EU, the notified body has the right to withdraw the certificate issued and force device manufacturers to remove the CE Mark from their products. Furthermore, the failure of a device manufacturer to maintain their quality management system (QMS) in compliance with ISO 13485:2003 can result in major deviations being issued by a notified body. These majors can also result in product being forced from the European Device market. Can you say RECALL? The best advice Dr. D can offer to save device manufacturers from receiving objurgations (look-it-up) from the Competent Authorities is to fully comply with all aspects of the Directive.
Full text of MDD – 93/42/EEC ANNEX VII (EC Declaration of Conformity) can be viewed here (pages 48-49).
What you need to know:
As Dr. D stated in the introduction for this edition of DG, Annex VII is all about the paper, the DoC and supporting documentation. Gosh, the doctor hates killing trees. Now I know much of this information is once again going to sound repetitive as many clauses nestled within the Annexes are applicable for a wide array of products. Regardless, Dr. D will try not to bore the readers too badly as I attempt to point out the salient elements device manufacturers need to know and understand in regards to Annex VII.
- Device manufacturers are required to create and sign a DoC that clearly delineates product information, device classification, compliance with the MDD, and applicable Annexes. Try not to kill too many trees.
- Device manufacturers are required to assemble technical documentation (technical files and design dossiers); and submit the documentation to their notified bodies for review and approval.
- Device manufacturers are required to keep technical documentation, including DoC’s and other documentation relevant to the Directive for a period of either five years or 15-years (for implantable devices). If a device manufacturer’s products are hurting people, they can take it to the proverbial bank, the Competent Authorities are going to want to dive into technical documentation.
- Since the technical documentation is being used by the notified body to assess a product’s compliance to the Directive and applicable harmonized standards (as depicted within the Essential Requirements Checklist, a.k.a., the ERC), certain pieces of information must be included in the submission. As a minimum:
a. General description of product and the intended use;
b. Design information, methods employed for manufacturing, drawing, specifications, and diagrams;
c. Description of salient functional performance and operational parameters as they pertain to the device and items depicted within b;
d. The application of risk analysis;
e. A compiled list of applicable standards employed to test and evaluate the product against essential requirements, remember the ERC;
f. Method of sterilization and sterilization validation process employed for sterile medical devices;
g. Results of all inspection and testing;
h. Testing of the product with ancillary devices, as appropriate;
i. Pre-clinical evaluation data;
j. Clinical data; and
k. The label and Instructions for Use (IFU); must be considered and if applicable, incorporated into the technical documentation package.
Similar to the other Annexes, post-market surveillance is a mission-critical requirement. Device manufactures are required to pursue corrective action when issues arise with their finished medical devices. Device malfunctions, deterioration over time, or other factors that influence the continued safety and efficacy of product must be addressed. Devices causing death or serious injury to the patient or user must be reported to the Competent Authorities. Remember, the EU has been working on an improved system for collection and analyzing vigilance reports. This improved competency is forcing medical device manufacturers to expedite product corrections or quickly remove offending product from market.
Class I sterile devices and devices with a measuring function must comply with Annex VII and the provisions depicted within Annexes II, IV, V, or VI, as applicable. Finally, there is once again an applicability element for Class IIa product.
What you need to do
What Dr. D is about to write is not some well-kept state secret. Well maybe it is, because the doctor continues to see device manufacturers struggle with compliance issues. The device market sandbox that a device manufacturer chooses to play in does not matter; however, compliance with the regulations applicable to that sandbox continues to be mandatory. Compliance with Annex VII of the MDD is no exception. That being said, a few of the “must dos” for device manufacturers are:
- The CJO must complete and sign a DoC;
- Technical documentation (technical file or design dossier) must be prepared and submitted to the notified body for review and approval;
- Technical documentation must be retained in accordance with the prescribed time, five or fifteen years;
- Pre-clinical and clinical evaluations, premised on well-written protocols and evaluated with recognized statistical methodologies, are required as applicable;
- Class I devices with a measuring function count, as do sterile devices so make sure they are tested in accordance with the appropriate Annexes; and
- Once again, do not forget about the applicability clause for Class IIa devices.
If a device manufacturer does not have the resources or is not willing to invest in executing the appropriate testing, inspection, verification, validation, creation of reports and technical documentation, then just maybe the device arena is the wrong venue. Dr. D would recommend horseshoes, but I am absolutely sure, they have strict standards too!
First off readers be patient, there are just five more Annexes remaining in this series of articles, with the last pertaining to CE Mark construction, fun-fun. As Dr. D leaps off his newly constructed podium (thank you skate boarders who took away my soapbox earlier), the message of compliance remains consistent and will never change. The goal of any device regulation and regulatory body, regardless of the country of origin, is the protection of public health by ensuring medical devices are safe and effective. It does not matter if it is a splinter needing to be pulled from the tongue of a patient with strep throat due to a faulty tongue depressor, or an angioplasty balloon catheter that fails to inflate in the hands of a skilled cardiologist. In each case, a device has failed to perform in its intended use.
On a serious note, and Dr. D can be serious on occasion, I have always approached the industry from the perspective of would I be comfortable having a family member or close friend on the receiving end of a medical device that I directly influenced the quality or reliability. If Dr. D cannot wake up, look in the mirror, and state an unequivocal “Yes” then I am in the wrong business.
Until the next installment of DG, when Dr. D will begin providing guidance for complying with Annex VIII (Statement Concerning Devices for Special Purposes) 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).
About the Author:
Dr. Christopher Joseph Devine is the President of Devine Guidance International, a consulting firm specializing in providing solutions for regulatory compliance, quality, supplier management, and supply-chain issues facing the device industry. Dr. Devine has 32 years of experience in quality assurance, regulatory compliance and program management. He is a senior member of the American Society for Quality (ASQ), a member of the Regulatory Affairs Professionals Society (RAPS), and a member of the Project Management Institute, and resides on several technical advisory boards. Dr. Devine received his doctorate from Northcentral University, with his doctoral dissertation titled, “Exploring the Effectiveness of Defensive-Receiving Inspection for Medical Device Manufacturers: A Mixed-Method Study.” Dr. Devine holds a graduate degree in organizational management (MAOM) and an undergraduate degree in business management (BSBM).