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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.
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.
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).
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.
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."
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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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