FINAL DRAFT
COMMUNICATION OF THE COMMISSION ON THE APPLICATION OF THE TRANSITIONAL PROVISIONS OF
DIRECTIVE 93/42/EEC RELATING TO MEDICAL DEVICES.
This communication refers to Article 22(4) of Directive 93/42/EEC concerning medical
devices. It aims at providing clarification on the aforementioned provision in order to
ensure its uniform application throughout the European Community.
Article 22(4) of Directive 93/42/EEC requires Member States to continue to
accept the placing on the market and the putting into service of devices which conform to
the rules in force in their territory on 31 December 1994 (pre-existing national rules)
during a period of five years following the adoption of the aforementioned Directive, i.e.
ending on 14 June 1998.
Accordingly, since 1st January 1995, when Directive 93'42/EEC became first applicable,
it has been possible to place medical devices on the market and put them into service
either in accordance with the pre-existing national rules or in compliance with Directive
93/42/EEC. From 15 June 1998, it will only be possible to place medical devices on
the market and put them into service if they comply with Directive 93/42/EEC.
The term "placing on the market" is defined in article 1(2)(h) of Directive
93/42/EEC as the "first making available in return for payment or free of charge of a
device … with a view to distribution and/or use on the Community market regardless of
whether it is new or fully refurbished". "Putting into service" means in
accordance with Article 1(2)(i) "the stage at which a device is ready for use on the
Community market for the first time for its intended use". The concepts of placing on
the market and putting into service refer to each individual product, and not to a
type of device.
The provision of Article 22(4) applies in relation to devices placed on the market
prior to 15 June 1998 in compliance with the pre-existing national rules of Member States.
Member States may require evidence on compliance with such rules and, where no specific
rules exists, on the assurance of an adequate level of safety of devices based on
general safety considerations.
Regarding the "putting into service" of those devices, the Commission
considers that a device reaches this stage as soon as it is ready for use in the
Community.
To a large extent, devices covered by Directive 93/42/EEC are ready for use at the time
they are placed on the market by the manufacturer. In fact, distribution or
other manipulations make no difference to their safety and performance, provided
manufacturers' instructions have been followed. These devices are considered as being put
into service at the same time when they are placed on the market. Therefore, such devices
which, have been made available by the manufacturer up to and including the 14 June
1998 may, after that date, continue to be transferred to end-users and used in
accordance with pre-existing national rules.
Some devices, prior to their use need further processing, for instance
sterilisation of surgical dressings, preparation of dental filling material, soaking and
fitting of contact lenses. Such kind of processing by the end-user, according to its
needs, is assigned to products by the manufacturer as part of the intended use. Relevant
devices should be considered as being ready for use even if the aforementioned processing
by the end-user has not yet taken place.
However, devices placed on the market which, in view of their first use, need to be
assembled or installed in the hospital and where these manipulations have an impact on
safety and/or performances of the devices, are not considered as "put into
service", unless the aforementioned activities have been carried out.
It should be noted that Article 22(4) as well as the definition of "putting into
service" within the meaning of Directive 93/42/EEC are currently under revision. Once
the forthcoming amendment of Article 22(4) which is currently going through the
legislative procedure will become applicable, the present interpretation will cease to
apply.
Please find hereafter EUCOMED's explanatory note on the above document:
TRANSITIONAL PERIOD
Final Draft of CEC Communication
Brussels, 05 June 1998
The latest position of the Commission of the European Communities (CEC) with regard to the
Transitional Provisions of the Directive 93/42/EEC relating to Medical Devices (MDD) is
now available.
This position has been circulated to Competent Authorities, European
Industry organisations, Users organisations, etc. The Communication make clear that
devices which do not bear CE Marking may nevertheless be supplied and used providing they
were properly placed on the market prior to 14 June 1998.
The Commission Legal Service has approved this Final Draft
Communication.
The document is now following the normal process for adoption by the Council of
Commissioners before it can be published as a COM document in the Official Journal of the
European Communities C-series. This adoption is not expected before late June. It may take
a further four weeks after the adoption before the document is published. Nothing more
official than final draft will be available before 14 June 1998.
The value of this document will still depend upon the willingness of
National Authorities to follow its spirit. Some Member States may wish to wait for the
official publication before adopting the recommended position. Other Member States may
still interpret certain aspects of the position in their own way or use some of the
provisions of paragraph 5 more extensively. Industry has reacted positively to this final
document and believes it will provide beneficial results. Whilst not ideal the document
does clarify an otherwise confused situation.
The Final Draft Communication refers to the current wording of MDD
93/42/EEC. The present interpretation contained in this final draft will cease to apply
once the forthcoming In-Vitro Diagnostic Medical Devices Directive (IVDD) is adopted and
published.
Article 21 of the draft IVDD (EU Council reference 5255/1/98 rev 1 of
23/03/1998) - amending other Directives - replaces Article 1(2)(i.) of the MDD 93/42/EEC
(the definition of "putting into service") as "the stage at which a device
has been made available to the final user as being ready for use in the Community market
for the first time for its intended use."
The same article of the IVDD replaces Article 22 (4) of the MDD
93/42/EEC by " Member States shall accept i.) devices which conform to the rules in
force in their territory on 31 December 1994 being placed on the market during a period of
five years following the adoption of this Directive and ii.) the aforementioned devices
being put into service until 30 June 2001 at the latest."
