- General information enquiries
- Call 00 800 6 7 8 9 10 11
- E-mail your questions
Directorate-General for Health and Food Safety
List of participants
MEMBERS
Prof. J.M. Boeynaems, Prof. J.R. Claude, Dr. W.H. De Jong, Prof. J.A. Guimarães Morais, Dr. J. Löwer, Prof. Dr. H.W.J. Marquardt, Prof. P. Preziosi, Dr. E. Rodriguez Farré, Prof. K. Turnheim, Prof. D.F. William
APOLOGIES
Dr. T.B. Barragry, Prof. J.G. Descotes, Dr. R. Dobbelaer, Dr. K.H. Jones, Prof. M. Silbermann, Prof. F. Sjöqvist
COMMISSION
Mme. De Solà (DG XXIV), M. J. Putzeys (DG III), M. G. Fracchia (DG XII), Mme. E. Cooke (DG III), M. A. Lacerda (DG III), Dr. A. Sanabria (DG XXIV)
EMEA
M. J.Purves (EMEA)
Prof. D.F. Williams chaired the meeting.
1. Approval of the Agenda
The agenda was adopted as follows:
1. Approval of the agenda.
2. Approval of the Draft Summary Report of the plenary meeting of 21 October 1998.
3. Information from the Commission on Medical Devices.
4. Information from the rapporteur of the Working Group on Medical Devices on the «Draft Guidelines on the use of specified risk materials for the manufacture of implantable medical devices».
5. Discussion of draft reports on «Authorised colouring agents for use in medicinal products».
6. Discussion and possible adoption of Draft «Guidelines on the concept of «clinical superiority» regarding legislation on orphan medicinal products.»
7. Information from the rapporteur of the Working Group «Antimicrobial resistance».
8. Information from the Commission on the use of E-mail in the Committee.
9. Other business
2. Approval of the Draft Summary Report of the plenary meeting of 21 October 1998.
The Draft Summary Report was approved as figures in document XXIV/SCMPMD/98.075 Final.
3. Information from the Commission on Medical Devices.
M. Putzeys explained the subject and presented the working program of DG III concerning the legislation on Medical Devices.
Subjects such as Definition of Medical Devices, Essential requirements for design and manufacture of medical devices, Reference to standards, Conformity assessment procedures, CE-Marking, surveillance of the market, etc., were presented.
As regards possible questions for submission to the Committee he mentioned dental amalgam and latex. When the reports by the W.G. of DG III are finalised, DG III will request the SCMPMD for their opinion on these subjects.
Other matters that could be put on the table of the Committee in the next few years are subjects related to the use of human tissues in medical devices, but before this a large debate is expected on the matter.
At the request of certain members of the Committee, Dr. Putzeys said that DG III could also request the Committee to give opinions on subjects such as specifications of diagnostic methods in vitro, specific questions made by Member States to clarified if a certain product must be considered as medical device or medicinal product, etc.
M. Putzeys thanked the Committee for the opinion given concerning "Sutures", and hoped for a good collaboration between their services and the Committee.
The Chairman thanked M. Putzeys for the explanation on the subject "Medical Devices", and for the responses given to the questions of several members of the SCMPMD.
4. Information from the rapporteur of the Working Group on Medical Devices on the «Draft Guidelines on the use of specified risk materials for the manufacture of implantable medical devices».
Prof. Williams, as rapporteur of the W.G. on the above mentioned subject, stated that the group met on 8 December 1998 in order to examine certain CEN documents in order to take them into account in the report.
These documents are not yet finalised and the group want to study them before drafting the report.
He said that the group could present a "Interim report" for the Plenary meeting of the SCMPMD on February, and submit the final final draft for approval at the April Plenary Meeting.
5. Discussion of draft reports on «Authorised colouring agents for use in medicinal products».
Prof. Preziosi said that because lack of data on Aluminium, Gold and Silver used in medicinal products the report had not progressed. He will continue to request data on the matters.
6. Discussion and possible adoption of Draft «Guidelines on the concept of «clinical superiority» regarding legislation on orphan medicinal products.»
Prof. Preziosi, as rapporteur of the W.G. on the subject, presented the Draft Report.
Following considerable discussion the Committee agreed that this draft be presented again for discussion and possible opinion at the next Plenary Meeting in order to take into account the observations to made in writing by the members to the rapporteur, and other possible inputs.
7. Information from the rapporteur of the Working Group «Antimicrobial resistance».
Prof. Preziosi explained the contribution made from the Working Group of the SCMPMD to the W.G. of the SSC on "Antimicrobial Resistance".
8. Information from the Commission on the use of E-mail in the Committee.
The Secretary of the SCMDMP requested the members of the Committee if they appreciated the use of E-mail for the communication between the Commission and the Committee.
The members agreed to continue with this type of transmission.
At the moment all members have E-mail address.
9. Other business
The Committee agreed the following dates for the Plenary Meetings of the SCMPMD in 1999:
10 February 1999
14 April 1999
2 June 1999
15 September 1999
27 October 1999
15 December 1999.
MEMBERS
Prof. J.M. Boeynaems, Prof. J.R. Claude, Dr. W.H. De Jong, Prof. J.A. Guimarães Morais, Dr. J. Löwer, Prof. Dr. H.W.J. Marquardt, Prof. P. Preziosi, Dr. E. Rodriguez Farré, Prof. K. Turnheim, Prof. D.F. William
APOLOGIES
Dr. T.B. Barragry, Prof. J.G. Descotes, Dr. R. Dobbelaer, Dr. K.H. Jones, Prof. M. Silbermann, Prof. F. Sjöqvist
COMMISSION
Mme. De Solà (DG XXIV), M. J. Putzeys (DG III), M. G. Fracchia (DG XII), Mme. E. Cooke (DG III), M. A. Lacerda (DG III), Dr. A. Sanabria (DG XXIV)
EMEA
M. J.Purves (EMEA)
Prof. D.F. Williams chaired the meeting.
1. Approval of the Agenda
The agenda was adopted as follows:
1. Approval of the agenda.
2. Approval of the Draft Summary Report of the plenary meeting of 21 October 1998.
3. Information from the Commission on Medical Devices.
4. Information from the rapporteur of the Working Group on Medical Devices on the «Draft Guidelines on the use of specified risk materials for the manufacture of implantable medical devices».
5. Discussion of draft reports on «Authorised colouring agents for use in medicinal products».
6. Discussion and possible adoption of Draft «Guidelines on the concept of «clinical superiority» regarding legislation on orphan medicinal products.»
7. Information from the rapporteur of the Working Group «Antimicrobial resistance».
8. Information from the Commission on the use of E-mail in the Committee.
9. Other business
2. Approval of the Draft Summary Report of the plenary meeting of 21 October 1998.
The Draft Summary Report was approved as figures in document XXIV/SCMPMD/98.075 Final.
3. Information from the Commission on Medical Devices.
M. Putzeys explained the subject and presented the working program of DG III concerning the legislation on Medical Devices.
Subjects such as Definition of Medical Devices, Essential requirements for design and manufacture of medical devices, Reference to standards, Conformity assessment procedures, CE-Marking, surveillance of the market, etc., were presented.
As regards possible questions for submission to the Committee he mentioned dental amalgam and latex. When the reports by the W.G. of DG III are finalised, DG III will request the SCMPMD for their opinion on these subjects.
Other matters that could be put on the table of the Committee in the next few years are subjects related to the use of human tissues in medical devices, but before this a large debate is expected on the matter.
At the request of certain members of the Committee, Dr. Putzeys said that DG III could also request the Committee to give opinions on subjects such as specifications of diagnostic methods in vitro, specific questions made by Member States to clarified if a certain product must be considered as medical device or medicinal product, etc.
M. Putzeys thanked the Committee for the opinion given concerning "Sutures", and hoped for a good collaboration between their services and the Committee.
The Chairman thanked M. Putzeys for the explanation on the subject "Medical Devices", and for the responses given to the questions of several members of the SCMPMD.
4. Information from the rapporteur of the Working Group on Medical Devices on the «Draft Guidelines on the use of specified risk materials for the manufacture of implantable medical devices».
Prof. Williams, as rapporteur of the W.G. on the above mentioned subject, stated that the group met on 8 December 1998 in order to examine certain CEN documents in order to take them into account in the report.
These documents are not yet finalised and the group want to study them before drafting the report.
He said that the group could present a "Interim report" for the Plenary meeting of the SCMPMD on February, and submit the final final draft for approval at the April Plenary Meeting.
5. Discussion of draft reports on «Authorised colouring agents for use in medicinal products».
Prof. Preziosi said that because lack of data on Aluminium, Gold and Silver used in medicinal products the report had not progressed. He will continue to request data on the matters.
6. Discussion and possible adoption of Draft «Guidelines on the concept of «clinical superiority» regarding legislation on orphan medicinal products.»
Prof. Preziosi, as rapporteur of the W.G. on the subject, presented the Draft Report.
Following considerable discussion the Committee agreed that this draft be presented again for discussion and possible opinion at the next Plenary Meeting in order to take into account the observations to made in writing by the members to the rapporteur, and other possible inputs.
7. Information from the rapporteur of the Working Group «Antimicrobial resistance».
Prof. Preziosi explained the contribution made from the Working Group of the SCMPMD to the W.G. of the SSC on "Antimicrobial Resistance".
8. Information from the Commission on the use of E-mail in the Committee.
The Secretary of the SCMDMP requested the members of the Committee if they appreciated the use of E-mail for the communication between the Commission and the Committee.
The members agreed to continue with this type of transmission.
At the moment all members have E-mail address.
9. Other business
The Committee agreed the following dates for the Plenary Meetings of the SCMPMD in 1999:
10 February 1999
14 April 1999
2 June 1999
15 September 1999
27 October 1999
15 December 1999.
