Evangeline Loh05.19.08
The Many Roads of Conformity Assessment
A Danish friend visiting the United States recently marveled at the variety and options available in an American grocery store. This wasn’t even a gourmet or “super chain” type of grocery store—just your garden-variety neighborhood establishment—and there even was another store in this monolithic chain within a seven-mile radius. As she pondered the preserves aisle, she couldn’t get over the vast variety of jams and jellies of all flavors and styles lavishing the shelves. When given many choices, is it liberating and empowering—or is it challenging—to secure a decision?
The 21 New Approach directives, which describe products subject to CE marking, similarly grant manufacturers a variety of decisions to make regarding how they demonstrate compliance with the regulations. For medical devices that require Notified Body involvement, a manufacturer may choose between different modules to demonstrate compliance and obtain the CE marking.
Classification of a medical device generally does not provide options. The classification rules (included in Annex IX of the Medical Devices Directive 93/42/EEC) were drafted to accommodate novel technology as devices are classified according to risk, invasiveness, technology and intended use, and the regulations do not mandate an existing product code before classification. That said, manufacturers have some flexibility in the selection of a technical solution to meet the health and safety requirements—ie, Essential Requirements. Depending on the class of device, manufacturers may choose from a range of conformity assessment procedures to demonstrate compliance with the directive. (The level of control associated with the procedures is correlated with the perceived risk associated with the device.)
Manufacturers often inquire if there is a strategy (or secret?) to selecting the appropriate conformity assessment route. Thankfully, many paths lead to Rome. Following are some options, or differences, in selecting a route to conformity assessment for a particular device.
Essential Requirements Really Are Essential
To meet the relevant Essential Requirements (Annex I) that must be met before CE marking, a manufacturer may use applicable European Norms harmonized standards published in the Official Journal of European Communities (OJEC), an international or national standard, or elect to work independently and use its own test specifications. Note that if the last option is chosen, the manufacturer obviously must substantiate the adequacy of its test specifications—though the requirements do not specify how to comply or satisfy the relevant delineated characteristics in Annex I. Use of harmonized standards published in the OJEC often is preferable because it presumes conformity with the Essential Requirements.
The Modular Approach
Under the New Approach directives, modules are selected for the Conformity Assessment procedure to demonstrate the product meets the applicable requirements of the directive (and can be CE marked accordingly). These modules relate to the design phase of products, their production phase or both phases. There are approximately eight basic modules—two fewer for medical devices—and variants can be combined with each other in several ways to establish complete conformity assessment.
Curiously, it has been observed that a few manufacturers are using Annex IV, EC Verification, as their conformity assessment procedure. In this mechanism, the notified body tests or examines every product individually according to the appropriate tests defined in relevant harmonized standards published in the OJEC. Further, homogenous batches may be presented to the notified body, to randomly sample a subset of the batch to release the batch. This can be an onerous procedure, as the notified body needs to test each device or batch before the devices can be CE marked, though MDD 2007/47/EC amends the previously required statistical parameters to ensure that sampling schemes are “state of the art” to demonstrate a “high level of safety and performance.”
Post-Marketing Surveillance and Vigilance
All conformity assessment procedures require the manufacturer possess a post-marketing surveillance and vigilance system. As emphasized by one high-ranking official at a recent conference of the Medicines and Healthcare product Regulatory Agency (a United Kingdom competent authority), these systems are regulatory requirements. Different routes exist, however, in terms of how a manufacturer demonstrates conformity assessment.
Class III devices. For Class III medical devices, it seems most sensible to use Annex II (including Section 4), Full Quality Assurance. While standards are voluntary, one way of presuming conformity to the Essential Requirements and meeting the provisions of full quality assurance is for a manufacturer to possess ISO 13485 certification, which pertains to a company’s quality management systems. Although ISO 13485 is a voluntary standard in Europe, it is a de facto expectation when manufacturers are implementing a full quality system. And in various parts of the world, some form of ISO 13485 certification is mandatory.
Possession of ISO 13485 certification especially makes sense if the manufacturer makes a wide range of high-risk medical devices. There are added costs associated with implementing an ISO 13485-certified quality system, which may deter smaller manufacturers from doing so. However, the overwhelming benefits should outweigh these costs.
It should be noted that manufacturers of Class III medical devices also have the option to pursue Annex III, EC Type Examination, in combination with Annex IV or Annex V, EC Declaration of Conformity (Production Quality Assurance).
Class IIa and IIb devices. Manufacturers of Class IIa and IIb devices also may elect the Annex II route with the exclusion of Section 4, Examination of the Design of the Product (since that section is only required for Class III devices)—hence, the recommendation that a manufacturer of many devices use the Annex II route as it simplifies the CE marking for its other devices: Class IIb, IIa and now Class I (measuring or sterile).
Note that Directive 2007/47/EC comments that even for devices other than Class III, the notified body is expected to “review the design documentation for the medical device.” The EU Commission mechanism provided to address this concern was a requirement that representative examples of design documents be reviewed. For Class IIa devices, it is expected that notified bodies assess one representative sample of each device subcategory; for Class IIb devices, it is expected that the examination include one representative sample for each generic device group. This certainly places more requirements on manufacturers that possess CE marking for a range of medical devices through Annex II, and it obviously would increase the notified bodies’ fees for both CE marking and annual surveillance audits.
Additional Conformity Assessment procedures that exist for Class IIa devices include Annex VII in conjunction with Annex IV, V or VI. Manufacturers of Class IIb devices also may select Annex III in combination with Annex IV, V or VI.
Class I devices. The route for a Class I self-declaration or self-certification medical device is Annex VII, EC Declaration of Conformity. Directive 2007/47/EC now also permits manufacturers to use Annex II (Recital 11) to obtain CE marking for Class I measuring and sterile devices, in addition to the previous annexes (IV, V and VI) available. Still, only the manufacturing aspects concerned with the sterility or manufacturing related to conformity with the meterology measuring function would be assessed by the notified body.
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Indeed, many roads lead to Rome, and each manufacturer’s route may be different. The decision regarding the conformity assessment route is determined by classification, expense (eg, Annex V is less costly than Annex II) and speed to market (eg, Annex IV sometimes is selected because it allows the manufacturer to get to the market more quickly—especially when there are distributors with pending orders—and it provides the manufacturer extra time to meet Annex II or Annex V).
In a Robert Frost poem, The Road Not Taken, the following words resonate: “Two roads diverged in a wood, and I—I took the one less traveled by, and that has made all the difference.” While there may not be as visible a difference in a manufacturer’s selection of a route, because the end result likely will be the same—ie, delivery of CE marked medical devices to the European market—it is an important business decision.