WRITTEN QUESTION E-2060/03 by Peter Liese (PPE-DE) to the Commission. Medical devices containing derivatives of human blood.
Date: 2003-06-20
Institutions: European Parliament, Provisional data
Subjects: Community certification, European Medicines Agency, European standard, medical device, pharmaceutical product, public health, testing

C 11 E/246

Official Journal of the European Union

EN

15.1.2004

(2004/C 11 E/274)

WRITTEN QUESTION E-2060/03

by Peter Liese (PPE-DE) to the Commission

(20 June 2003)

Subject: Medical devices containing derivatives of human blood

Since 13 June 2002, medical devices incorporating stable derivatives of human blood or human plasma
have been subject to a new procedure for authorisation under Directive 2000/70/EC (1). The notified body
must seek a scientific opinion from the EMEA on the quality and safety of the derivative of human blood.
The usefulness of the derivative as a part of the medical device must be verified, taking account of the
intended purpose of the device. The notified body may certify the device only if the EMEA has delivered a
favourable scientific opinion.

It has become clear from the implementation of this certification procedure that the text of the directive is
unclear with regard to the scope and intensity of the EMEA’s competence when verifying such devices. In
particular, it appears to be unclear whether the EMEA may verify only the derivative as such, or whether
the directive is to be interpreted as requiring the usefulness, quality and safety of the derivative to be
verified together with the medical device,
‘taking account of the intended purpose of the device’. If the
latter interpretation is adopted (cid:1) as it has been by the EMEA (cid:1) then the content and duration of the
entire procedure amounts in practice to a procedure for the authorisation of medicinal products plus an
additional CE certification, with the corresponding duplication of checks by the notified body and the
EMEA.

1.

Is the Commission aware of this situation?

2. Will the Commission take action to remedy the problem? If so, what steps does the Commission
propose?

(1) OJ L 313, 13.12.2000, p. 22.

Answer given by Mr Liikanen on behalf of the Commission

(1 August 2003)

The Commission is aware of the fact that Directive 2000/70/EC of the 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, raises some issues of interpretation on the role of the
European Agency for the Evaluation of Medicinal Products (EMEA).

The Commission and national authorities responsible for the implementation of the Medical Devices
Directive have elaborated a modus operandi that respects the willingness of the Council and Parliament to
distinguish EMEA’s role with regard to blood derivatives and medicinal products. The modus operandi
makes a distinction between substances for which an opinion (either by EMEA or a national authority) has
or has not already been established and clarifies the scope of EMEA’s involvement with respect to that of
the Notified Body.

In the light of experience, the Commission may propose regulatory clarification of the Council Directive
93/42 EEC of 14 June 1993 on medical devices (1) as modified by Directive 2000/70 EC.

(1) OJ L 169, 12.7.1993.