Common Position (EC) No 40/2000 of 29 June 2000 adopted by the Council, acting in accordance with the procedure referred to in Article 251 of the Treaty establishing the European Community, with a view to adopting a Directive of the European Parliament and of the Council amending Council Directive 93/42/EEC as regards medical devices incorporating stable derivatives of human blood or human plasma
Date: 2000-06-29
Institutions: Council of the European Union
Subjects: approximation of laws, artificial reproduction, medical device, public health, single market

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COMMON POSITION (EC) No 40/2000

adopted by the Council on 29 June 2000

with a view to adopting a Directive of the European Parliament and of the Council of (cid:133)
amending Council Directive 93/42/EEC as regards medical devices incorporating stable derivatives
of human blood or human plasma

(2000/C 245/04)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

Having regard to the Treaty establishing the European
Community, and in particular Article 95 thereof,

Having regard to the proposal from the Commission (1),

Having regard to the opinion of
Committee (2),

the Economic and Social

Acting in accordance with the procedure laid down in Article
251 of the Treaty (3),

Whereas:

remain excluded from the scope of

substances derived from human
the said

incorporating other
tissues
Directive.

(3) The essential aim of any rules governing the production,
distribution or use of medical devices must be to
safeguard public health.

(4)

Furthermore, national provisions for the safety and health
protection of patients, users and, where appropriate, other
persons, with regard to the use of medical devices must
be harmonised in order to guarantee free movement of
such devices within the internal market.

(5) Medical devices

incorporating,

an integral part,
substances derived from human blood or plasma have the
same purposes
is
therefore no reason to treat them differently as regards
their free circulation.

as other medical devices. There

as

(1)

In addition to being directed at medical devices for in vitro
diagnosis,
to amend
the Commission proposal sought
Council Directive 93/42/EEC of 14 June 1993 concerning
medical devices (4) in order to extend its scope to medical
devices manufactured by using non-viable tissues or
substances of human origin derived from those tissues.
This
in Directive
not
amendment was
98/79/EC (5) when it was adopted.

included

(6) Medical devices

incorporating, as an integral part, a
substance derived from human blood or plasma and
which is liable to act on the body with action ancillary to
that of the device must comply with the provisions of
Council Directive 93/42/EEC and other
instruments
supplementing the said Directive.

(2) This Directive accordingly aims at amending Directive
93/42/EEC so as to include in its scope only devices
which incorporate, as an integral part, substances derived
from human blood or plasma. However, medical devices

(1) OJ C 172, 7.7.1995, p. 21 and OJ C 87, 18.3.1997, p. 9.
(2) OJ C 18, 22.1.1996, p. 12.
(3) Opinion of the European Parliament of 12 March 1996 (OJ C 96,
1.4.1996, p. 31), Council Common Position of 29 June 2000 and
European Parliament Decision of (cid:133) (not yet published in the
Official Journal).

(4) OJ L 169, 12.7.1993, p. 1. Directive as amended by Directive
98/79/EC of the European Parliament and of the Council (OJ L
331, 7.12.1998, p. 1).

(5) Directive 98/79/EC of the European Parliament and of the Council
of 27 October 1998 on in vitro diagnostic medical devices (OJ L
331, 7.12.1998, p. 1).

(7) A human blood derivative,

if used separately, may be
considered to be a medicinal product constituent within
the meaning of Council Directive 89/381/EEC (6). When it
is incorporated into a medical device, the substance must
be
checks by analogy with
Directives 75/318/EEC (7) and 89/381/EEC; these checks

to appropriate

subject

75/319/EEC on

of Directives 65/65/EEC and

(6) Council Directive 89/381/EEC of 14 June 1989 extending the
scope
the
approximation of provisions laid down by law, regulation or
administrative action relating to proprietary medicinal products and
laying down special provisions for medicinal products derived from
human blood or human plasma (OJ L 181, 28.6.1989, p. 44).
(7) Council Directive 75/318/EEC of 20 May 1975 on the
approximation of the laws of Member States relating to analytical,
pharmaco-toxicological and clinical standards and protocols in
respect of the testing of medicinal products (OJ L 147, 9.6.1975, p.
1). Directive as last amended by Commission Directive 1999/83/EC
(OJ L 243, 15.9.1999, p. 9).

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will be carried out by the authorities empowered to
implement the aforesaid Directives,

HAVE ADOPTED THIS DIRECTIVE:

Article 1

Directive 93/42/EEC is amended as follows:

1.

In Article 1:

(a)

the following paragraph shall be inserted:

(cid:145)4a. Where a device incorporates, as an integral
part, a substance which,
if used separately, may be
considered to be a medicinal product constituent or a
medicinal product derived from human blood or
human plasma within the meaning of Article 1 of
Directive 89/381/EEC (*) and which is liable to act on
the human body with action ancillary to that of the
device, hereinafter referred to as a (cid:147)human blood
and
device must
derivative(cid:148),
authorised in accordance with this Directive.

assessed

that

be

(*) Council Directive 89/381/EEC of 14 June 1989
extending the scope of Directives 65/65/EEC and
75/319/EEC on the approximation of provisions
laid down by law,
regulation or administrative
action relating to proprietary medicinal products
and laying down special provisions for medicinal
products derived from human blood or human
plasma (OJ L 181, 28.6.1989, p. 44).(cid:146)

(b)

in paragraph 5, point
following:

(e) shall be replaced by the

(cid:145)(e) human blood, blood products, plasma or blood
cells of human origin with the exception of
human blood derivatives;(cid:146).

2. Annex I shall be amended as follows:

(a)

in Section 7.4, the following subparagraphs shall be
added:

(cid:145)Where a device incorporates, as an integral part, a
human blood derivative, the notified body shall seek a
scientific opinion from the European Agency for the
Evaluation of Medicinal Products
(EMEA) on the
quality and safety of the derivative, taking account of
in
the
particular, by analogy with the provisions of Directives
75/318/EEC and 89/381/EEC. The usefulness of the
derivative as a part of the medical device shall be
verified, taking account of the intended purpose of the
device.

appropriate Community provisions

and,

accordance with Article

In
of Directive
89/381/EEC, a sample from each batch of bulk and/or
finished product of the human blood derivative shall
be tested by a State laboratory or a laboratory
designated for that purpose by a Member State.(cid:146);

4(3)

(b)

in Section 13.3, the following subparagraph shall be
added:

(cid:145)(n) in the case of a device within the meaning of
the device

an indication that

Article 1(4a),
contains a human blood derivative.(cid:146)

3. Annex II shall be amended as follows:

(a)

in Section 3.2(c), the fifth indent shall be replaced by
the following:

(cid:145)(cid:151) a statement indicating whether or not the device
incorporates, as an integral part, a substance or a
human blood derivative referred to in Section 7.4
of Annex I and the data on the tests conducted in
this connection required to assess the safety,
quality and usefulness of
substance or
human blood derivative, taking account of the
intended purpose of the device.(cid:146);

that

(b)

in Section 4.3, the second and third subparagraphs
shall be replaced by the following subparagraphs:

first subparagraph,

(cid:145)In the case of devices referred to in Annex I, Section
the notified body shall, as
7.4,
regards the aspects referred to in that section, consult
the competent bodies designated by the
one of
Member
accordance with Directive
65/65/EEC before taking a decision. The notified body
will give due consideration to the views expressed in
this consultation when making its decision.
It will
convey its
final decision to the competent body
concerned.

States

in

In the case of devices referred to in Annex I, Section
7.4, second subparagraph, the scientific opinion of the
EMEA must be
included in the documentation
concerning the device. The notified body will give due
consideration to the opinion of
the EMEA when
making its decision. The notified body may not deliver
the certificate if
scientific opinion is
unfavourable. It will convey its final decision to the
EMEA.(cid:146);

the EMEA’s

(c)

the following section shall be added:

(cid:145)8. Application to the devices referred to Article 1(4a)

On completing the manufacture of each batch
the
of devices

referred to in Article 1(4a),

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manufacturer shall inform the notified body of the
release of the batch of devices and send to it the
official certificate concerning the release of
the
batch of human blood derivative used in the
device, issued by a State laboratory or a laboratory
designated for that purpose by a Member State in
accordance with Article
of Directive
89/381/EEC.(cid:146)

4(3)

designated for that purpose by a Member State in
accordance with Article 4(3) of Directive 89/381/EEC.(cid:146)

6.

In Annex V, the following section shall be added:

(cid:145)7. Application to devices referred to in Article 1(4a):

4. Annex III shall be amended as follows:

(a)

in Section 3, the sixth indent shall be replaced by the
following:

(cid:145)(cid:151) a declaration stating whether or not the device
incorporates, as an integral part, a substance or
human blood derivative, referred to in Section
7.4 of Annex I, and the data on the tests
conducted in this connection which are required
to assess the safety, quality and usefulness of that
substance or human blood derivative,
taking
account of the intended purpose of the device,(cid:146);

On completing the manufacture of each batch of
devices referred to in Article 1(4a), the manufacturer
shall
inform the notified body of the release of the
batch of devices and send to it the official certificate
concerning the release of the batch of human blood
derivative used in the device issued by a State
laboratory or a laboratory designated for that purpose
by a Member State in accordance with Article 4(3) of
Directive 89/381/EEC.(cid:146)

7.

In Annex IX, Part
subparagraph shall be added:

III, Section 4.1,

the

following

(cid:145)All devices incorporating, as an integral part, a human
blood derivative are in class III.(cid:146)

(b)

in Section 5, the second and third subparagraphs shall
be replaced by the following subparagraphs:

Article 2

first subparagraph,

(cid:145)In the case of devices referred to in Annex I, Section
7.4,
the notified body shall, as
regards the aspects referred to in that section, consult
the competent bodies designated by the
one of
Member
accordance with Directive
65/65/EEC before taking a decision. The notified body
will give due consideration to the views expressed in
this consultation when making its decision.
It will
final decision to the competent body
convey its
concerned.

States

in

In the case of devices referred to in Annex I, Section
7.4, second subparagraph, the scientific opinion of the
EMEA must be
included in the documentation
concerning the device. The notified body will give due
consideration to the opinion of
the EMEA when
making its decision. The notified body may not deliver
the certificate if
scientific opinion is
unfavourable. It will convey its final decision to the
EMEA.(cid:146)

the EMEA’s

5.

In Annex IV, the following section shall be added:

(cid:145)9. Application to devices referred to in Article 1(4a):

In the
case of Section 5, on completing the
manufacture of each batch of devices referred to in
Article 1(4a), and in the case of verification under
Section 6, the manufacturer shall inform the notified
body of the release of this batch of devices and send
to it the official certificate concerning the release of
the batch of human blood derivative used in the
device issued by a State laboratory or a laboratory

Implementation, transitional provisions

shall

laws,
1. Member States
regulations and administrative provisions necessary to comply
with this Directive before (cid:133) (*). They shall immediately inform
the Commission thereof.

and publish the

adopt

Member States shall apply these measures with effect from
(cid:133) (**).

When Member States adopt these measures, they shall contain
a reference to this Directive or shall be accompanied by such
reference on the occasion of
their official publication. The
methods of making such reference shall be laid down by the
Member States.

2. Member States shall communicate to the Commission the
text of the main provisions of domestic law which they adopt
in the field governed by this Directive.

account of

3. Member States shall take the necessary action to ensure
that
to
the notified bodies which are responsible pursuant
Article 16 of Directive 93/42/EEC for conformity assessment
take
information regarding the
characteristics and performance of such devices, including in
particular the results of any tests and verification already
law, regulations or
carried out under pre-existing national
administrative provisions in respect of such devices.

relevant

all

(*) One year after the date of entry into force of this Directive.
(**) Eighteen months after

the date of entry into force of

this

Directive.

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4.
During a period of five years following the entry into
force of this Directive, Member States shall accept the placing
on the market of such devices which conform to the rules in
force in their territory on the date on which this Directive
enters into force. For a further period of two years, the said
devices may be put into service.

Article 4

This Directive is addressed to the Member States.

Article 3

Done at (cid:133)

This Directive shall enter
publication in the Official Journal of the European Communities.

into force on the day of

its

For the European Parliament

The President

For the Council

The President

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STATEMENT OF THE COUNCIL’S REASONS

I.

INTRODUCTION

1. On 19 April 1995, the Commission submitted to the Council (1) a proposal for a Directive

concerning in vitro diagnostic medical devices.

2. The Economic and Social Committee delivered its opinion on 25 October 1995 (2).

3. The European Parliament delivered its opinion at first reading on 12 March 1996 (3). Following
the opinion of the European Parliament, the Commission submitted an amended proposal (4) to
the Council in a letter dated 23 December 1996.

4. On 29 June 2000, the Council adopted its Common Position in accordance with Article 251 of

the Treaty.

II. OBJECTIVE OF THE PROPOSAL

5. The medical devices sector is subject to Community harmonisation governing the placing of
products on the market, in order to protect patients, users and third parties. The majority of
medical devices are already covered by the Directives on active implantable medical devices
(90/385/EEC) and medical devices (93/42/EEC).

The purpose of the proposal for a Directive is to supplement the Community legal framework
governing the conditions for placing medical devices on the market by extending the scope of
Directive 93/42/EEC, firstly to in vitro diagnostic medical devices which had been excluded
because of their specific nature, and secondly to medical devices incorporating non-viable tissues
of human origin.

III. ANALYSIS OF THE COMMON POSITION

6. The Commission included in its amended proposal almost all the amendments suggested by the

Parliament.

7. During the legislative procedure on the proposal,

in agreement with the
Commission, decided to make a split and initially to draw up a Common Position only on in
vitro diagnostic medical devices.

the Council,

8.

For that part of the proposal, all the amendments proposed by the Parliament were adopted by
the Council.

9. The European Parliament approved the split and proposed at second reading an amendment to
that effect, stressing the need to legislate rapidly on medical devices manufactured from
substances of human origin. That amendment was incorporated in recital 35 of Directive
98/79/EC on in vitro diagnostic medical devices, adopted on 27 October 1998.

(1) OJ C 172, 7.7.1995, p. 21.
(2) OJ C 18, 22.1.1996, p. 12.
(3) OJ C 96, 1.4.1996, p. 31.
(4) OJ C 87, 18.3.1997, p. 9.

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10. The text of the present Common Position is the result of the continuation of work at Council

level on the part of the proposal still outstanding.

However, agreement could be reached only on a Directive limited to devices containing
derivatives of human blood or plasma. Devices incorporating other substances derived from
human tissue will have to be the subject of a specific Directive.

11. Accordingly, the text of the Common Position is limited to amending Directive 93/42/EEC to

incorporate provisions on substances derived from human blood or plasma.

12. Consequently, two of the five amendments (amendments 33, 36, 37, 38 and 39) relating to the
inclusion of medical devices made from products derived from tissues and cells from the human
body in Directive 93/42/EEC, proposed by the Parliament and adopted by the Commission,
namely amendments 33 and 36 on the scope of Directive 93/42/EEC, have become irrelevant
because the scope of the Common Position is limited.

In fact, amendment 33 proposed that the concept of (cid:145)non-viable tissues or cells of human origin(cid:146)
in Article 1(5)(f) of Directive 93/42/EEC should be made more specific and amendment 36
referred to amendment of the reference to the above provision in point 8.2 of Annex I.

13. Amendments 37 (concerning an addition to the labelling requirements in point 13.3 of Annex I
to Directive 93/42/EEC), 38 (concerning amendment of the requirements on the EC conformity
declaration in point 3.2(c) of Annex II) and 39 (concerning the addition of the medical devices
covered by this Directive to class III of the classification system in Annex IV) were adopted by
the Council with the necessary adjustment to take account of the fact that the scope is limited to
devices incorporating stable derivatives of human blood or plasma.

14.

Since derivatives of human blood are considered to be a medicinal product within the meaning
of Directive 89/381/EEC on special provisions for medicinal products derived from human blood
or plasma, and, accordingly, medical devices containing those derivatives must guarantee the
same level of quality and safety as medicinal products when used, they must be subject to the
existing Community evaluation and verification procedures for medicinal products.

15. Consequently, provisions have been added to the Directive to apply those procedures to the
medical devices in question. They are paragraphs 1(a) and (b), 2(a), 3(b) and (c), 4(b), 5 and 6 of
Article 1.