Evangeline Loh03.31.09
The realities of the current state of the financial markets have led many organizations to look for different ways to market or deliver their medical devices. A medical device firm recently asked our company about its responsibility for assembling products for sale in Europe. The organization wanted to include all of the medical devices required to perform a certain procedure in one simple package and asked a series of “what-if” questions:
• What if all the individual medical devices in the assembled kit possessed CE marking?
• What additional requirements are there?
• What if some of the medical devices did not possess a CE mark?
• What if there were components that were not medical devices—a medicinal product, for example?
To sufficiently present information about medical device kits, companies must understand possible “what-if” scenarios.
What are the definitions? Directive 2007/47/EC inserted many definitions into the European Union’s Medical Devices Directive MDD 93/42/EEC (MDD). However, the definitions for systems and procedure packs were nonexistent. Borrowing from multiple sources, including a guidance document issued by the Irish competent authority, the Irish Medicines Board, systems are medical devices that are assembled for use in combination as a unit. Procedure packs are medical devices packaged together and placed on the market for use in medical treatment or surgical procedures. Procedure packs are identical to their kit or convenience kit brethren. Article 12 of the MDD 93/42/EEC addresses system and procedure packs. Obviously, the first consideration should be to assess that the products indeed are medical devices or accessories to medical devices, which are medical devices in their own right (reference, MDD definition and Annex IX, Classification Criteria, 2.2).
What about Article 12 on systems and procedure packs? This article of the MDD allows an entity—an assembler—that “puts devices bearing the CE marking together within their intended purpose and within the limits of use specified by their manu-facturers” and satisfies a few other requirements to market the products without bearing an additional CE marking. It likely was a little misleading to include the Article 12 discussion in the September 2007 column. Really, according to Article 12, an assembler is not a medical device manufacturer per se, as the CE marking is not associated with them. Rather, the assembler puts together devices that have the CE marking.
There are, however, conflicting definitions for some of these terms that could make things more confusing. The Finnish competent authority, the National Agency for Medicines, in their guidance (Normative Guideline 3/2005) strictly interpreted the definition of a system or procedure pack to meet the conditions specified in Article 12, paragraph 2. According to the Finnish definition: The individual medical devices possess CE marking; medical devices are used according to their indications for use; and medical devices are not used outside their restrictions. That said, paragraph 2 of the MDD 93/42/EEC includes a disclaimer that if some of the individual medical devices do not possess CE marking, Article 11, Conformity Assessment, must be followed.
Thus, to use Article 12, the first condition is that the individual medical devices must have CE marking. The other requirements include assessing the mutual compatibility of the devices according to the original manufacturers’ instructions; supplying relevant information to use the device, including incorporating relevant instructions from the original manufacturers; and ensuring appropriate methods of internal control and inspection. If all the above conditions are satisfied, the assembler issues a declaration. Again, note that that the assembler does not affix the CE mark to the system and procedure pack since each of the individual medical devices has CE marking and the medical devices are used as intended by the original manufacturer.
If Article 12 assemblers have procedure packs where all the medical devices have CE marking, what’s next? Assemblers must register their Article 12 system or procedure pack with the member state competent authority in which they are established. And, if not established in the European Union (EU), assemblers must designate a European authorized representative who must register the Article 12 system or procedure pack.
What if the products in a system or procedure pack all are medical devices but do not all possess CE mark? Manufacturers that bundle different devices that do not possess the CE mark must select the appropriate route to conformity assessment based on the classification of the bundled medical devices. If some of the medical devices possess CE mark according to paragraph 7, the manufacturer of the procedure pack can presume the relevant requirements of the MDD are met for those medical devices. Further, manufacturers need to consider the Essential Requirements (ER), Annex I, 9.1, which specifies that devices used in combination with other devices must be compatible and safe. Also, ER 13.6 (c) stipulates the expectations for the instructions for use.
What if the products in a system or procedure pack are not all medical devices? Each component should be assessed to understand the regulatory requirements that need to be addressed for each individual component. And, the appropriate regulatory compliance must be obtained for the product. For example, if the procedure pack includes pharmaceutical products, those products must be compliant to the Medicinal Product Directive 2001/ 83/EC.The products must be labeled accordingly. The risk assessment should document that these medicinal products are to be used as intended by the medicinal product manufacturer and provided with the relevant information for use. To minimize the complexity of the situation—provided the primary intended purpose of the kit is as a medical device—the organization would be well-advised to ensure that the other components have the relevant applicable EU approvals.
To answer the “what-ifs” associated with kits, we recommend the following considerations:
1. Article 12: In a procedure pack or system, ensure that all medical devices possess CE marks and are used as intended;
2. Article 11: Determine whether all the medical devices possess CE marking, or if all medical devices with CE marking are not being used as ascribed by the initial indications for use that had CE marking
3. For products that are not medical devices, ensure they all have applicable regulatory approvals.
Limited guidance has been published on this topic, but, by considering the above, hopefully the “what-ifs” of procedure packs or systems has been explained.
• What if all the individual medical devices in the assembled kit possessed CE marking?
• What additional requirements are there?
• What if some of the medical devices did not possess a CE mark?
• What if there were components that were not medical devices—a medicinal product, for example?
To sufficiently present information about medical device kits, companies must understand possible “what-if” scenarios.
Definitions of System and Procedure Pack
What are the definitions? Directive 2007/47/EC inserted many definitions into the European Union’s Medical Devices Directive MDD 93/42/EEC (MDD). However, the definitions for systems and procedure packs were nonexistent. Borrowing from multiple sources, including a guidance document issued by the Irish competent authority, the Irish Medicines Board, systems are medical devices that are assembled for use in combination as a unit. Procedure packs are medical devices packaged together and placed on the market for use in medical treatment or surgical procedures. Procedure packs are identical to their kit or convenience kit brethren. Article 12 of the MDD 93/42/EEC addresses system and procedure packs. Obviously, the first consideration should be to assess that the products indeed are medical devices or accessories to medical devices, which are medical devices in their own right (reference, MDD definition and Annex IX, Classification Criteria, 2.2).
Article 12: System and Procedure Packs
What about Article 12 on systems and procedure packs? This article of the MDD allows an entity—an assembler—that “puts devices bearing the CE marking together within their intended purpose and within the limits of use specified by their manu-facturers” and satisfies a few other requirements to market the products without bearing an additional CE marking. It likely was a little misleading to include the Article 12 discussion in the September 2007 column. Really, according to Article 12, an assembler is not a medical device manufacturer per se, as the CE marking is not associated with them. Rather, the assembler puts together devices that have the CE marking.
There are, however, conflicting definitions for some of these terms that could make things more confusing. The Finnish competent authority, the National Agency for Medicines, in their guidance (Normative Guideline 3/2005) strictly interpreted the definition of a system or procedure pack to meet the conditions specified in Article 12, paragraph 2. According to the Finnish definition: The individual medical devices possess CE marking; medical devices are used according to their indications for use; and medical devices are not used outside their restrictions. That said, paragraph 2 of the MDD 93/42/EEC includes a disclaimer that if some of the individual medical devices do not possess CE marking, Article 11, Conformity Assessment, must be followed.
Thus, to use Article 12, the first condition is that the individual medical devices must have CE marking. The other requirements include assessing the mutual compatibility of the devices according to the original manufacturers’ instructions; supplying relevant information to use the device, including incorporating relevant instructions from the original manufacturers; and ensuring appropriate methods of internal control and inspection. If all the above conditions are satisfied, the assembler issues a declaration. Again, note that that the assembler does not affix the CE mark to the system and procedure pack since each of the individual medical devices has CE marking and the medical devices are used as intended by the original manufacturer.
Article 12: Assemblers Register
If Article 12 assemblers have procedure packs where all the medical devices have CE marking, what’s next? Assemblers must register their Article 12 system or procedure pack with the member state competent authority in which they are established. And, if not established in the European Union (EU), assemblers must designate a European authorized representative who must register the Article 12 system or procedure pack.
Medical Device Compatibility
What if the products in a system or procedure pack all are medical devices but do not all possess CE mark? Manufacturers that bundle different devices that do not possess the CE mark must select the appropriate route to conformity assessment based on the classification of the bundled medical devices. If some of the medical devices possess CE mark according to paragraph 7, the manufacturer of the procedure pack can presume the relevant requirements of the MDD are met for those medical devices. Further, manufacturers need to consider the Essential Requirements (ER), Annex I, 9.1, which specifies that devices used in combination with other devices must be compatible and safe. Also, ER 13.6 (c) stipulates the expectations for the instructions for use.
Non-Medical Devices
What if the products in a system or procedure pack are not all medical devices? Each component should be assessed to understand the regulatory requirements that need to be addressed for each individual component. And, the appropriate regulatory compliance must be obtained for the product. For example, if the procedure pack includes pharmaceutical products, those products must be compliant to the Medicinal Product Directive 2001/ 83/EC.The products must be labeled accordingly. The risk assessment should document that these medicinal products are to be used as intended by the medicinal product manufacturer and provided with the relevant information for use. To minimize the complexity of the situation—provided the primary intended purpose of the kit is as a medical device—the organization would be well-advised to ensure that the other components have the relevant applicable EU approvals.
Conclusion
To answer the “what-ifs” associated with kits, we recommend the following considerations:
1. Article 12: In a procedure pack or system, ensure that all medical devices possess CE marks and are used as intended;
2. Article 11: Determine whether all the medical devices possess CE marking, or if all medical devices with CE marking are not being used as ascribed by the initial indications for use that had CE marking
3. For products that are not medical devices, ensure they all have applicable regulatory approvals.
Limited guidance has been published on this topic, but, by considering the above, hopefully the “what-ifs” of procedure packs or systems has been explained.