Directive 2000/70/EC of the European Parliament and of the Council of 16 November 2000 amending Council Directive 93/42/EEC as regards medical devices incorporating stable derivates of human blood or human plasma
Date: 2000-11-16
Institutions: Council of the European Union, European Parliament
Subjects: European standard, blood transfusion, pharmaceutical legislation, pharmaceutical product, product safety, public health

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Official Journal of the European Communities

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DIRECTIVE 2000/70/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 16 November 2000

amending Council Directive 93/42/EEC as regards medical devices incorporating stable derivates of
human blood or human plasma

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 the Economic and Social
Committee (2),

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

Whereas:

(6)

(7)

Medical devices incorporating, as an integral part, a
substance derived from human blood or plasma and
which is liable to act upon the body with action ancil-
lary to that of the device must comply with the provi-
sions of Directive 93/42/EEC and other instruments
supplementing the said Directive.

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 subject to appropriate checks by analogy with
Council Directives 75/318/EEC (7) and 89/381/EEC.
These checks will be carried out by the authorities
empowered to implement the aforesaid Directives,

(1)

(2)

(3)

(4)

(5)

the Commission proposal sought

In addition to being directed at medical devices for in
vitro diagnosis,
to
amend 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 amendment was not included in
Directive 98/79/EC (5) when it was adopted.

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 incorporating other substances derived from
human tissues remain excluded from the scope of the
said Directive.

The essential aim of any rules governing the production,
distribution or use of medical devices must be to safe-
guard public health.

Furthermore, national provisions for the safety and
health protection of patients, users and, where appro-
priate, 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.

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

HAVE ADOPTED THIS DIRECTIVE:

Article 1

Directive 93/42/EEC is hereby amended as follows:

1. Article 1 shall be amended as follows:

(a) the following paragraph shall be inserted:

‘4 a. Where a device incorporates, as an integral part,
a substance which, if used separately, may be consid-
ered to be a medicinal product constituent or a medi-
cinal 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 upon the
human body with action ancillary to that of the device,
hereinafter referred to as a “human blood derivative”,
that device must be assessed and authorised in accord-
ance with this Directive.

(*) 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).’;

(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 (OJ C
245, 25.8.2000, p. 19) and European Parliament Decision of 24
October 2000.

(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).

(6) 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).

(7) Council Directive 75/318/EEC of 20 May 1975 on the approxima-
tion 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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(b) in paragraph 5, point

(e) shall be replaced by the

following:

‘(e) human blood, blood products, plasma or blood
cells of human origin with the exception of
human blood derivatives;’

2. Annex I shall be amended as follows:

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 the EMEA's scientific opinion
is unfavourable. It will convey its final decision to the
EMEA.’;

(a)

in section 7.4, the following subparagraphs shall be
added:

(c)

the following section shall be added:

‘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
the appropriate Community provisions and, in partic-
ular, by analogy with the provisions of Directives 75/
318/EEC and 89/381/EEC. The usefulness of
the
the medical device shall be
derivative as a part of
verified,
the intended purpose of
the device.

taking account of

In accordance with Article 4(3) 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 desig-
nated for that purpose by a Member State.’

(b) in section 13.3, the following subparagraph shall be

added:

‘(n) in the case of a device within the meaning of
the device

Article 1(4a),
an indication that
contains a human blood derivative.’

3. Annex II shall be amended as follows:

(a)

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

‘— 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,
substance or
quality
human blood derivative,
the
intended purpose of the device.’;

and usefulness of

taking account of

that

(b) in section 4.3,

the second and third subparagraphs

shall be replaced by the following subparagraphs:

first subparagraph,

‘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
one of
the competent bodies designated by the
in accordance with Directive 65/
Member States
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.

‘8. Application to the devices

referred to Article

1(4a):

inform the notified body of

Upon completing the manufacture of each batch
of devices referred to in Article 1(4a), the manu-
facturer shall
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 labora-
tory designated for that purpose by a Member
State in accordance with Article 4(3) of Directive
89/381/EEC.’

4. Annex III shall be amended as follows:

(a)

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

‘— 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
that
the
and
substance or human blood derivative,
taking
account of the intended purpose of the device.’;

usefulness

quality

safety,

of

(b) in section 5,

the second and third subparagraphs

shall be replaced by the following subparagraphs:

first subparagraph,

‘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 States
in 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.

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 the EMEA's scientific opinion
is unfavourable. It will convey its final decision to the
EMEA.’

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5.

In Annex IV, the following section shall be added:

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

In the case of section 5, upon completing the manu-
facture 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 designated for
that purpose by a Member State in accordance with
Article 4(3) of Directive 89/381/EEC.’

6.

In Annex V, the following section shall be added:

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

Upon 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 labora-
tory or a laboratory designated for that purpose by a
Member State in accordance with Article 4(3) of
Directive 89/381/EEC.’

7.

In Annex IX, Part III, section 4.1, the following subpara-
graph shall be added:

‘All devices incorporating, as an integral part, a human
blood derivative are in Class III.’

Article 2

Implementation, transitional provisions

1. Member States shall adopt and publish the laws, regu-
lations and administrative provisions necessary to comply
with this Directive before 13 December 2001. They shall
immediately inform the Commission thereof.

Member States shall apply these measures with effect from
13 June 2002.

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

these measures,

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.

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

this Directive, Member States

During a period of five years following the entry into
4.
the
force of
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.

shall accept

Article 3

This Directive shall enter into force on the date of its publi-
cation in the Official Journal of the European Communities.

This Directive is addressed to the Member States.

Article 4

Done at Brussels, 16 November 2000.

For the European Parliament

For the Council

The President

N. FONTAINE

The President

R. SCHWARZENBERG