Article 12, of Council Directive 93/42/EEC, a.k.a., the Medical Device Directive (MDD) delineates the requirements for “Particular Procedure for Systems and Procedure Packs and Procedure for Sterilization Conformity Assessment Procedures.” Article 12 is all about declarations and compliance with Annex II (EC Declaration of Conformity – Full Quality Assurance System) and Annex V (EC Declaration of Conformity – Production Quality Assurance).
Systems and procedure packs, being introduced into the European Union (EU) for commerce, require a written declaration, by the manufacturer, stating compliance to the requirements outlined in Article 12. The device manufacturer’s Chief Jailable Officer (CJO) or an assigned and competent delegate (that looks good in an orange jumpsuit); should be the duly charged with the task of signing the declarations. Additionally, the sterilization facility employed to perform the sterilization on the systems or procedure packs is expected to sustain a recognizable quality system in accordance with Annex II or Annex V of the MDD. That said, the organization performing the sterilizer is also duly tasked with creating a signed declaration delineating compliance with the manufacturer’s specifications.
Dr. D would like to make a point, “Competent and qualified sterilization facilities will have an effective quality management system when such systems are approved by a recognized notified body.” Finally, when devices from multiple manufacturers are included in procedure packs, Section 13 (Information Supplied by the Manufacturer) of Annex I (Essential Requirements) will apply. In short, device manufacturers need to control all of the devices being placed into the procedure packs.
One final thought, remember to hold onto all of the declarations collected. Why? Because these declarations need to be kept, “at the disposal of the competent authorities.” The minimum length of retention will be five years. As with all editions of DG, Dr. D can never be accused of being farouche (look-it up). That said, I hope you enjoy this week’s guidance.
The MDD – 93/42/EEC
Article 12 – Particular Procedure for Systems and Procedure Packs and Procedure for Sterilization
1. By way of derogation from Article 11 this Article shall apply to systems and procedure packs.
2. Any natural or legal person who puts devices bearing the CE marking together within their intended purpose and within the limits of use specified by their manufacturers, in order to place them on the market as a system or procedure pack, shall draw up a declaration by which he states that:
(a) he has verified the, mutual compatibility of the devices in accordance with the manufacturers’ instructions and has carried out his operations in accordance with these instructions; and
(b) he has packaged the system or procedure pack and supplied relevant information to users incorporating relevant instructions from the manufacturers; and
(c) the whole activity is subjected to appropriate methods of internal control and inspection. Where the conditions above are not met, as in cases where the system or procedure pack incorporate devices which do not bear a CE marking or where the chosen combination of devices is not compatible in view of their original intended use, the system or procedure pack shall be treated as a device in its own right and as such be subjected to the relevant procedure pursuant to Article 11.
3. Any natural or legal person who sterilizes, for the purpose of placing on the market, systems or procedure packs referred to in paragraph 2 or other CE-marked medical devices designed by their manufacturers to be sterilized before use, shall, at his choice, follow one of the procedures referred to in Annex II or V. The application of the above mentioned Annexes and the intervention of the notified body are limited to the aspects of the procedure relating to the obtaining of sterility until the sterile package is opened or damaged. The person shall draw up a declaration stating that sterilization has been carried out in accordance with the manufacturer’s instructions.
4. The products referred to in paragraphs 2 and 3 themselves shall not bear an additional CE marking. They shall be accompanied by the information referred to in point 13 of Annex I which includes, where appropriate, the information supplied by the manufacturers of the devices which have been put together. The declarations referred to in paragraphs 2 and 3 shall be kept at the disposal of the competent authorities for a period of five years.
What you need to know
As Dr. D stated in the introduction for this edition of DG, declarations and compliance to Annex II and Annex V is everything when complying with Article 12. For those readers that live and breathe the MDD, on a daily basis, the concept of signed declarations is considered routine. However, systems and procedure packs are really in a unique niche and that is why Article 12 is so important. Systems and procedure packs are scenarios where it is possible to have devices from multiple manufacturers and multiple notified bodies placed together to form a singular operating unit or device. For example, an RF Ablation System may have the RF generator from one device manufacturer, a foot-switch and an interface box from another. Somehow, all of this information needs to be collected and retained; henceforth, Article 12. That being said, device manufacturers need to know that there are critical steps associated with this Article.
The first thing device manufacturers need to know and understand is what information is deemed required in the declarations. For systems and procedure packs, there are three salient requirements.
- The manufacturer tasked with system or procedure pack creation/integration must ensure all of the devices work together, in accordance with their manufacturing instructions.
- The packaged systems or procedure packs must include relevant manufacturer instructions.
- The entire system or procedure pack must meet all of the applicable controls and inspections identified by the manufacturer assembling the systems and packs for resale. If devices incorporated as part of the system or procedure pack are not CE marked, or the packaged compilation of devices are not compatible, in regards to their original intended use, the Article 11 of the MDD is invoked as the governing requirement for the device.
As expected, sterilization matters. What, device manufacturers have to sterilize procedure packs Dr. D? Not only does sterilization count, in the eyes of the competent authorities and the notified bodies, the sterilization facility better have a quality system compliant with Annex II or V of the Directive. How is compliance achieved? The doctor is a big proponent of EN ISO 13485:2003. That said, the only sure-fire way to ensure a sterilizer is compliant with the Directive and EN ISO 13485, is to ask for a copy of their valid certificates, issued by a recognized notified body.
Finally, ensure all of the declarations and applicable certificates are retained for all of the devices included in a system or a procedure pack. Having a strong purchasing and supplier management system in place will facilitate the appropriate controls. In fact, Dr. D strongly recommends having supplier agreements in place for all procured devices.
What you need to do
As a device manufacturer, you need to understand the context of Article 12 and ensure systems and procedure packs are handled accordingly. In assembling systems and procedure packs, device manufacturers routinely handle devices with multiple CE marks. One watch out pertains to the presence of a CE Mark. Ensure the CE marks from other device manufactures are not obliterated as part of the packaging or lost in the documentation. Capturing the devices in the actual labeling of the system or procedure pack is extremely important.
As for the sterilizer, employing one that has been approved by a recognized notified body, i.e., TUV-R, BSI, TUV-SUD, DEKRA, etc. (no Dr. D is not a paid spokesperson for these organizations) is mission critical. Why? Not wanting to state the obvious but obliged to do so, selecting a sterilization facility that has been approved by a recognized notified body, ensures compliance to En ISO 13485 and the MDD has been achieved. Finally, ensure all of the declarations for each of the devices associated with a system or procedure pack are retained for at least 5-years. It is a requirement that these declarations be at the disposal of the competent authorities for at least 5-years.
In regards to this edition’s takeaways, Dr. D will leave you with five points:
1. Device manufacturers need to do their homework when assembling systems or procedure packs. It is incumbent upon the manufacturer to ensure that:
a. The appropriate approvals are in place for each device;
b. The devices work together as advertised; and
c. Appropriate instructions are available.
2. Only work with a sterilizer that has been approved by a recognized notified body.
3. Ensure each of the devices have a CE mark and the appropriate approvals in place. It will make your life much easier.
4. Make sure the labeling for systems and procedure packs contain correct references to the devices included.
5. Documentation is important. Ensure declarations, for each of the devices, are retained for at least five years.
Until the next installment of DG, when Dr. D will provide guidance for complying with Article 12a (Reprocessing of Medical Devices) 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.
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).
Excellent explanation about Art.12. Readable also for ‘rookies’ Now I am looking to – kind of- flow chart about the mandatory steps to meet the requirements and how to create the procurement agreement, including the quality agreement with the specific details on Art.12, between the purchasingcompany ( and selling the PP to the market) and all involved suppliers of components.
Next to this:
What about the supplier of the component supplier.
Who is or/and will be responsible at the end to submit any required information to the company bringing the PP into the market? Is this the supplier of the component to the PP mfg.
E.g. if a FSCA will be actual and after investigation the root cause and analysis of the affected components showed more than one component which caused the FSCA, What will be the best decision to inform the customer: Put all track & traced completePP on hold for further instructions? or only the affected component(s) if these are separated sterile packed in the PP.
Looking forward to your reply. In advance: Thanks a lot and kind regards. Ruud (the Netherlands)