In this edition of Devine Guidance (DG), Dr. D will dissect and provide guidance for complying with Article 2 of Council Directive 93/42/EEC concerning medical devices, a.k.a., the MDD. In the initial articles, for this series of DG, the doctor explained the salient requirement for a CE Mark to be affixed to the labeling of product being introduced into commerce within the European Economic Community (EEC).
Additionally, Dr. D explained that device manufacturers could not arbitrarily affix the CE Mark, since the CE Mark actually belongs to the notified bodies. Does that mean once a notified body is selected, the purchase order issued, and the contract signed, device manufacturers can affix a CE Mark and start shipping product into Europe? The answer to this question would be a resounding ‘no.’ And this edition of DG will explain why.
The MDD – 93/42/EEC
Article 2 – Placing on the market and putting into service
Member States shall take all necessary steps to ensure that devices may be placed on the market and/or put into service only if they comply with the requirements laid down in this Directive when duly supplied and properly installed, maintained and used in accordance with their intended purpose.
Initial steps toward compliance
Similar to the Quality System Regulation (QSR) enforced by FDA within the United States, the MDD is the European equivalent of the QSR required for the introduction of medical devices into the EEC. Just like the QSR, compliance with the MDD is mandated by law. For those of you that have been following DG for some time, Dr. D would like to remind the readers and invoke DG Rule # 1 – Compliance to regulations is not optional, it is mandatory and dictated by law.
Now having established that “compliance is mandatory,” Article 2 of the MDD becomes relatively easy to understand. Simply stated, Article 2 requires each of the member states, i.e., Ireland, England, Italy, etc. to ensure that all devices entering into commerce comply with this Directive. Additionally, there is no mention of partial compliance, exclusion from compliance, maximum compliance, or similar nonsensical clauses associated with Article 2. If you really want to see the hackles raised on the back of Dr. D, try to convince me there is a beast such as partial compliance to a Directive, standard, or regulation.
If partial compliance was an acceptable approach, then regulatory bodies would develop partial regulations. Does the logic make sense now? Dr. D wants to ensure that when organizations tackle the task of trying to understand and interpret the MDD, a common-sense approach is pursued versus holding the Directive in numinous (look-it up if you must) awe.
How does an organization start down the path of introducing product into Europe? Dr. D recommends selecting a qualified notified body. As I have stated in previous editions of DG, there are some exceptional notified bodies (BSI, TUV-R, etc.) capable of assisting organizations with the navigation of the regulatory waters associated with compliance to the MDD. For example, if an organization selected TUV-Rheinland (no Dr. D is not a paid spokesperson for TUV-R), once all of the requirements of this Directive are met, a CE Mark containing TUB-R’s identification number 0197, could be affixed to the labeling of approved medical devices and shipped into Europe.
Once a notified body has been selected, the next step is to have the quality system evaluated against the requirements delineated within EN ISO 13485:2003. As I will discuss in a later edition of DG, compliance to this standard is mandated by the Directive, and not optional. If your organization is already complying with the QSR, a few minor tweaks are all that should be required to comply with 13485. One piece of advice Dr. D would like to offer is; I strongly recommend the creation of a compliance matrix that links both the QSR and the MDD to how requirements are achieved within your quality system (link each requirement to a written procedure). As your organization grows, such as expansion into the Japanese market, e.g., Ordinance 169 for Japan, the matrix can easily be expanded.
The next step is to submit technical documentation, for review, to the notified. Depending on the device classification (Class I, IIa, IIb, or III) the requirement will be the assembling of either a Technical File or a Design Dossier (Class III only). The Technical File and/or Design Dossier will contain all of the technical documentation to support compliance to the MDD, including testing performed in accordance with recognized standards, preferably (although not mandated) European Harmonized Standards. Remember, Dr. D strongly suggests the employment of Harmonized Standards when performing device-qualification testing, design-verification testing, validation testing, etc. Trust me, it will simplify the review and approval process of Tech Files and Design Dossiers.
Additionally, before writing off a Harmonized Standard as not being applicable for a particular device, ensure written rational is provided documenting that the standard was considered. Now that does not mean every-single Harmonized Standard needs to be considered; however, relevant standards should always be considered. For example, EN 980:2008 delineates the symbols for labeling required for product released for distribution within the EU. Not only should this standard be considered, expect to receive a deviation from your notified body if the symbols employed on labeling are incorrect. In fact, failure to comply with this standard can result in product being quarantined by member states. Can you say RECALL? Yes, once again that nasty six-letter word resurfaces. Seriously folks, accuracy counts in regards to device labeling.
If the medical devices, to be introduced for commerce into the EU are manufactured outside of the EU, the selection and employment of a European Authorized Representative will be required. As Dr. D has previously stated, it is very important that a signed-written agreement be in place that delineates the responsibilities of the European Authorized Representative and the legal manufacturer of the device. Having a purchase order in place will not suffice; and your notified body will take exception. Can you say where do I sign the deviation form?
Once the European Authorized Representative is onboard, the notified body has approved your quality system, and the Technical File or Design Dossier has been reviewed and approved (including the device labeling); certificates are ready to be issued by the notified body. For example, for a Class III device you can expect to receive a certificate that certifies that your quality system complies with EN ISO 13485. Additionally, (for a Class III device) you can expect to receive a Design Examination Certificate (DEC) that documents compliance with the MDD.
Furthermore, your organization will be tasked with creating a European Declaration of Conformity (DoC), The DoC will contain the actual path of conformity claimed, e.g., Class III, rule 7 according to annex IX of the MDD. The DoC contains information specific to the approved medical device such as:
- Legal Manufacturer;
- Manufacturing Site(s);
- European Authorized Representative’s Address;
- Product Name;
- List of Approved Model Numbers and Description;
- Path of Conformity;
- Name and Address of Notified Body, including CE Mark ID Number;
- Date of First CE Mark; and
- The Signature of the Chief Jailable Officer (CJO) – typically the highest-ranking regulatory affairs individual.
Finally, you can expect to receive an Annex II.3 Certificate (Full Quality Assurance System Approval) and/or an Annex V.3 (Quality System Production) from your notified body. These certificates document products approved and their manufacturing site, versus the specific MDD Annex and Article.
Dr D’s Rodomontade
For those of you that read DG on a weekly basis, I thank you. By now I hope each of you have reached the conclusion that Dr. D always preaches compliance. The doctor would never want to be in a position to have colleagues heap contumely on me for allowing medical device companies to pursue a path of “minimal compliance” to Directives, European, or otherwise. Why? Because – there is no such thing as minimal compliance to Directives. There is no such thing as maximum compliance to Directives. There is no such thing as partial compliance to Directives. There is only compliance. Please, please, and pretty-please with sugar on top, compliance is a concept that needs to be understood. Otherwise, placing devices onto the market in the EU, or anywhere else for that fact, will become a daunting task.
Are you surprised that Dr. D could be so verbose when discussing an Article that contains just one sentence? For the long-time followers of DG, you folks are probably not surprised, as I have been known not to know when to stop with the ranting and preaching. That said, I know the doctor may have drifted a little bit with the addition of cursory information needed to support the placement of product into the EU; however, the path to compliance commences with Article 2 (the doctor’s opinion).
Article 2 is eloquently simple and yet, very specific at the same time. What does that mean Dr. D? What it means is that device manufactures shall comply with the MDD if they want to sell medical devices in Europe. It does not get any simpler than this to understand. Compliance to this Directive is not optional – period! Additionally, Dr. D provided insight and guidance into some of the salient steps required to enter the EU device market. Remember, a few of the salient items required for device manufacturers, wishing to enter the EU are:
- Select and contract with a competent notified body;
- Ensure the quality system is compliant with EN ISO 13485:2003;
- Contract with a European Authorized Representative;
- Assemble a Technical Files and/or Design Dossier, considering and hopefully employing European Harmonized Standards;
- Verify label accuracy for products to be introduced into the EU (remember EN 980);
- Obtain all of the applicable certificates from the notified body; and
- Complete and sign the DoC.
Remember, a competent notified body can help with the specific details. Why? Because that is what medical device manufacturers, pay the notified body to do.
In closing, thank you again for joining Dr. D and I hope you find value in the guidance provided. Until the next installment of DG, when Dr. D will provide guidance for complying with Article 3 (essential requirements) of Council Directive 93/42/EEC, the MDD – cheers from Dr. D. and best wishes for continued professional success.
Code of Federal Regulation. (2010, April). Title 21 Part 820: Quality system regulation. Washington, D.C.: U. S. Government Printing Office.
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 980:2008. (2008, July). Symbols to be used in the labeling of medical devices.
EN ISO 13485:2003. (2004, February). Medical devices – quality management systems – requirements for regulatory purposes (ISO 13485:2003).