CE MARKING CONFORMITY

ASSESSMENT OPTIONS FOR MEDICAL

DEVICE COMPANIES

Author
Evangeline Loh, PhD, RAC (US, EU)
Vice President Global Regulatory Affairs

www.EmergoGroup.com

29 March 2016
The Many Roads of European CE Marking Conformity Assessment
In Europe, all medical devices must comply with the relevant Essential Requirements delineated in
Annex I of the Medical Devices Directive 93/42/EEC (MDD). Compliance with the Essential
Requirements is generally demonstrated by means of compliance with European Norm (EN)
harmonized standards, published in the Official Journal of European Union (OJEU). While standards
are voluntary, compliance with EN harmonized standards presume compliance with the relevant
Essential Requirements. In addition to compliance with the Essential Requirements, an appropriate
route to conformity assessment (Annexes II through VII) must be selected. The route is, in part,
determined by device classification.

Classification of a medical device provides few options. The classification rules (included in Annex IX
of the MDD) 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 your device, you 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.

The New Legislative Framework directives, which describe products subject to CE marking, present
manufacturers with several methods to demonstrate compliance with medical device regulations.
For medical devices that require Notified Body involvement, a manufacturer may choose between
different modules to demonstrate compliance and obtain the CE marking.

Manufacturers often inquire if there is a strategy 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), a manufacturer may use applicable
European Norms harmonized standards published in the OJEU, an international or national
standard. You may also elect to work independently and use your own test specifications. Note that
if the last option is chosen, you must substantiate the adequacy of your 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 OJEU is preferable because it presumes
conformity with the Essential Requirements and facilitates review by the Notified Body, a third-party
entity-auditor.

The records demonstrating compliance to the MDD are compiled in a document termed the
Technical File (or, for a Class III medical device, Design Dossier). Class I measuring, Class I sterile,
Class IIa, Class IIb, or Class III medical devices require a Notified Body to review the documentation

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and issue a CE marking certificate. In the case of Class I devices (non-sterile/non-measuring),
compliance is demonstrated through a self-certification route in which the manufacturer self-affixes
the CE Mark as a legally binding attestation.

Conformity assessment routes by device classification

Device classification is the most significant factor when choosing a conformity selection route for
your device. Here we will discuss conformity routes to consider based on the class type.

Class III devices

For Class III medical devices, Annex II (including Section 4 Examination of the product), Full Quality
Assurance is a viable option. While standards are voluntary, one way of presuming conformity to the
Essential Requirements and meeting the provisions of full quality assurance is 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.

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 may choose the Annex II route with the exclusion of
Section 4, as that section is only required for Class III devices. A manufacturer of many devices
should consider using the Annex II route because it simplifies 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.

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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 only 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), excluding Section 4, 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 sterility or meterology
measuring function would be assessed by the Notified Body.

Post-Marketing Surveillance and Vigilance

All conformity assessment procedures require the manufacturer to implement a post-marketing
surveillance and vigilance system. These systems are regulatory requirements. The manufacturer is
expected to establish an active set of procedures and processes for collecting data for devices on
the market, called post-marketing surveillance. An aspect of post-marketing surveillance is vigilance.

The Modular Approach

Under the New Legislative Framework 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. There are approximately eight basic modules - two fewer for
medical devices - and variants can be combined in several ways to establish complete conformity
assessment.

Some manufacturers use 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. Further, homogenous batches may be
presented to the Notified Body to randomly sample a subset of the batch, or 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. Directive 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."

Distribution between different conformity assessment modules under MDD

Results from a 2014 medical device survey of 25 Notified Bodies by Team NB (The European
Association of Medical Devices Notified Bodies) revealed that Annex II is by far the most popular
conformity assessment route, followed by Annex V and Annex II (including EC design examination).
The graph below illustrates the relative popularity of various conformity assessment routes.

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 EC design
examination
including
combination
product
1%
Annex 2
including EC
design
examination
20%
Annex 3
2%
Annex 2
47%

Annex 4
4%
Annex 5
24%
Annex 6
1%
* ECDE: EC Design
Examination
- EC design examination with
drug consultation: answers
from 9 NBs.

Conclusion
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, it is an important business decision. The decision regarding the
conformity assessment route is determined by classification, expense (eg, Annex V is less costly than
Annex II, excluding Section 4), and speed to market (eg, Annex IV sometimes is selected because it
allows the manufacturer to get to the market faster - especially when there are distributors with
pending orders - and it provides the manufacturer extra time to meet Annex II or Annex V).

To learn more:
Emergo helps medical device companies with CE Marking and device registration in markets
worldwide. To learn more, visit http://www.emergogroup.com/services.

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