By: Theo
Nusselder
Additional conformity requirements:
Meeting the new European
Medical Device Directives is not a choice, it is the law whose regulations are
upheld by all member states of the European Union: Austria, Belgium, Denmark,
UK, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, The
Netherlands, Portugal and Sweden. And also by the member countries of the
European Free Trade Association: Iceland, Liechtenstein and Norway.
The Medical Device Directive (MDD) effective date is June 14, 1993 and
the transition period will end June 14, 1998.
After June 14, 1998 all medical devices (including Orthotic and
Prosthetic) must meet the Medical Directive requirements, with the exception of
In-Vitro-Diagnostic products for which separate directive is being drafted.
Complying with the Medical Device Directive (MDD)
requirements for Orthotic and Prosthetic Devices falls largely under risk
category I, which allows the manufacturer to self-certify.
Self-certification means complying with the requirements outlined in the
MDD and compiling documentation as to how this was accomplished. This is called
a technical file which must be placed in Europe to be available to the
Competent Authorities only , within reasonable period of time. ( About 2
working days). Any delivery delays result in loss of credibility of the file.
At a minimum, the technical file documentation consists of:
Additional documentation requirements are:
Once the technical file documentation is completed, the manufacturer must
declare that it's products are in compliance with the MDD by issuing a written
"declaration of conformity". Next the devices must be registered with
a Competent Authority by the manufacturer or his European Authorized
Representative.
All manufacturers outside the European Union States must designate an European
Authorized Representative, whose name and address must be shown on the product,
the labels and/or user instructions. A manufacturer has options, he can appoint
one of his distributors or agents as its Authorized Representative. But keep in
mind that the distributor in country A may not be to thrilled when the name of
distributor in country B appears on all products! PLUS REMEMBER! The technical
file containing the aforementioned documentation must be placed with each
designated entity. A better option is an independent Authorized Representative,
knowledgeable in the MDD requirements and the workings of the Competent
Authority.
Manufacturers of individualized devices should be
aware of the difference between custom made and adapted devices.
Custom made devices are intended for sole use by a particular patient
and produced in accordance with specifications prescribed by a qualified
practitioner. A mass produced medical device that only needs adaptation is not
a custom made device. Custom made devices do not carry a visible CE mark but
remain subject to the Medical Device Directive requirements. The manufacturer
must issue a statement of conformity for each device stating the patient's
name, device identification, responsible medical practitioners
Custom made (non-mass produced) medical devices must still meet the MDD
requirements, but are exempt from a CE mark being affixed to the actual device.
These custom made devices must be reported at regular intervals to the
competent authorities.
Adapted devices are assembled and/or processed according to the
manufacturer's instructions by an orthopedic practitioner (in Europe). This
device must be CE marked by the manufacturers whose name appears on the
product. If the product is processed without manufacturer instructions, or if
the practitioner deviates from the manufacturer instructions, the practitioner
becomes the manufacturer and must meet the MDD requirements and CE mark the
device.
Risk Class I devices that are sterile or perform a
measuring function must be assessed by an independent assessment institute,
called a "Notified Body". The Notified Body will only assess the
aspects of the sterility or measurement function.
Devices that fall in Risk Class IIa, IIb or III by definition of the Medical
Device Directive must also apply for an assessment by a Notified Body which may
include product testing and/or quality system audits.
European customers and/or patients may no
longer use non-CE marked devices after June 14 '98. Devices placed in the
distribution channel before June 14 '98 may continue to be sold for a period of
2 years.
Customs may perform visual checks before clearing the product for entry
into any European Union State.
The Competent Authority will perform random or systematic checks of all
CE marked devices.
Competitors may report any non-compliant device to the authorities.
Non compliance may mean non-CE marked or incorrectly
labeled products. If a devicet does not comply with the requirements of the
Medical Device Directive, Member States are obliged to take measures against
the manufacturer and/or his Authorized Representative. As an extreme measure,
limitations can be imposed on the manufacturer or a device can even be
prohibited from being sold and used. Member States must inform the European
Commission and other Member States if they take this sort of measure. The
manufacturer commits an economic offense and can be prosecuted for such.
The intent of the Medical Device Directive is to standardize medical device
safety requirements throughout all members of the European Union States and
applies to foreign and domestic manufacturers equally.
CEpartner4U is a consulting firm and authorized representative in Maarn,
The Netherlands and can be reached via Ph: +31-343.442.524 or Fax: +31-343.442.162
or e-mail: office@cepartner4u.nl and
invites you to visit their Website www.cepartner4u.nl