2008年 5月 8日
It's no secret that today's medical device manufacturers are a diverse lot that exist in many different shapes and sizes. Previous articles have described products that are medical devices in Europe; however, have you ever considered if your organization actually falls into the defined terms of what is considered a "manufacturer" in Europe and how some of your relationships might expedite the CE marking of devices?
This article defines and explains the different types of medical device manufacturers, categorized by how they conduct their operations. Understanding the differences in the manufacturing models may make a difference in your regulatory strategy and the cost of obtaining necessary approvals.
Among Europe's three medical device directives - Active Implantable Medical Device Directive 90/385/EEC, Medical Device Directive (MDD) 93/42/EEC, and In Vitro Diagnostic Directive 98/79/EC - the definition of what constitutes a manufacturer is identical:
"Natural or legal person with responsibility for the design, manufacture, packaging and labeling (sic) of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party."
The pivotal provision that qualifies a medical device manufacturer, as such, is the characteristic of placing the medical device on the market "under his own name." The manufacturer clearly is responsible for the medical device manufacturing operations, though the functions described can be variously delegated or subcontracted. And many manufacturers variously have subcontracted the design, manufacture, packaging and labeling operations of their medical devices.
Deciphering the Various Models of Manufacturers
Following are some groupings that have been acknowledged as individual models of medical device manufacturers:
- Conventional medical device manufacturers perform all functions of medical device manufacturing on their premises/facilities
- Some manufacturers outsource portions of their manufacturing
- Virtual manufacturers outsource all medical device operations
- Some manufacturers assemble systems and procedure packs
- Many more manufacturers contract with manufacturers that already possess CE marking so they can brand the devices as their own
Discussion is not required to explain the conventional medical device manufacturer that, in its own facilities, on its own premises, physically makes the product and performs all the functions: design, manufacture, packaging and labeling. It must be noted, though, that to some extent, all manufacturers outsource a portion of their manufacturing, since they receive components from third-party vendors.
Virtual manufacturers are a newer phenomenon. Fostered by global markets and the increasing quality provided by foreign countries - where labor traditionally has been a cheaper commodity - some manufacturers have outsourced their entire operations and conduct business without any physical manufacturing plants. In addition, virtual manufacturing offers an opportunity to use well-established companies for the different operations.
Manufacturers that assemble systems and procedure packs are capitalizing on Article 12 of the MDD, which will be discussed further in this article, as will manufacturers that place products under their own name or trademark but may not be involved in design, manufacture, packaging or labeling.
Manufacturers of Systems and Procedure Packs
One of the less-known provisions and requirements that occur frequently in practice are natural or legal persons who assemble systems and procedure packs (Article 12 MDD). Systems are medical devices assembled to be used 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. This article of the MDD allows a manufacturer that "puts devices bearing the CE marking together within their intended purpose and within the limits of use specified by their manufacturers," and satisfies a few other requirements, to market the products without bearing an additional CE marking. The other requirements include assessing the mutual compatibility of the devices in accord with the manufacturers' instructions, supplying relevant information to use the device and ensuring appropriate methods of internal control and inspection.
Limited guidance has been published on this topic. It is advisable that if the class of the system or procedure pack would require notified body involvement (Class I sterile or measuring, Class IIa, Class IIb or Class III), the manufacturer should consult with the notified body about the applicability of this article to its device.
Manufacturers That Brand Devices as Their Own
Numerous terms have been circulating to describe a manufacturer ("Manufacturer B") that contracts with a manufacturer ("Manufacturer A") already in possession of CE marking to brand the medical devices as its own. This permits identical medical devices to be placed on the market under different manufacturers. Just to introduce a few monikers, Manufacturer B has been called Own Brand Labeler (OBL), Private Brand Labeler (PBL) or Private Label Manufacturer (PLM). Manufacturer A could be an Original Equipment Manufacturer (OEM), Original Equipment Supplier (OES) or an "actual manufacturer."
Contrary to popular belief, the OBL alone assumes the total regulatory responsibility for the device once its own name is on the device as the manufacturer. In other words, you don't just point the finger at the OEM if something goes wrong with the device. The OBL also must issue the Declaration of Conformity and obtain the CE marking for the device as the manufacturer. Further, the devices that the OBL brands as its own cannot be modified from the OEM's version and typically only are purchased, stored and marketed under the OBL's own name. Thus, the labeling (label and instructions for use) cannot be altered drastically, except for modifications to the device name or trade name, or for modifications to improve the label.
A technical or quality agreement should be established between the OBL and OEM to delineate the respective responsibilities for each party, such as the OEM's obligation to keep all unit production records as well as any related documents (such as quality system documents) for a period of five years after the last product has been manufactured. The OBL should have implemented standard operating procedures for post-marketing surveillance and a medical device vigilance system. The OBL also should review the OEM's essential requirements checklist, declaration of conformity and CE marking certificates, if notified body involvement is necessary for CE marking.
If the medical device is a Class I self-certify (self-declaration), the OBL would self-certify the medical device and apply the CE marking, provided the documents discussed above exist, including the quality agreement. If notified body involvement is mandated because of the class, the OBL would submit the following for review by the subsequent Notified Body: OBL and OEM labeling (label and instructions for use); OBL and OEM declaration of conformity; technical and quality agreement between the OBL and OEM; the OEM's CE marking certificates, and the OBL's standard operating procedures for post-marketing surveillance and a medical device vigilance system. The newly issued CE marking certificate would piggyback on the existing CE marking certificate held by the OEM, but this is not disclosed on the OBL's certificate.
Are You a Medical Device Manufacturer?
In Europe, a medical device manufacturer is the entity whose name is on the label and who assumes responsibility for design, manufacture, packaging and labeling. The manufacturer must possess CE marking for its device.
The good news is that a manufacturer's obligations and the requirements for CE marking a medical device are delineated in the directives.
- Stewart Eisenhart