European Policy News

25/03/2014

European Medicines Agency’s Management Board endorses revised policy on handling of declarations of interests

Please click HERE to view the pdf document

 

Med Tech Policy

I. Status-quo of the Medical Devices Regulation

On 26 September 2012 the European Commission publishes a proposal for a new Regulation on Medical Devices (COM 2012 542).

Details of the proposal can be found in the link below:

http://www.europarl.europa.eu/registre/docs_autres_institutions/commission_europeenne/com/2012/0542/COM_COM(2012)0542_EN.pdf

 

Two separate paragraphs relating to “substance-based medical devices and medical devices utilised in the process of aphaeresis” have been deleted.

1.         Annex I, Point 9.2

Devices that are composed of substances or combination of substances intended to be ingested, inhaled or administered rectally or vaginally and that are absorbed by or dispersed in the human body shall comply, by analogy, with the relevant requirements laid down in Annex I to Directive 2001/83/EC.”

2.         Annex VII, part III, Point 6.9, Rule 21

 Devices that are composed of substances or combination of substances intended to be ingested, inhaled or administered rectally or vaginally and that are absorbed by or dispersed in the human body are in class III.”

II. Status-quo of the in-vitro Medical Devices Regulation

The European commission has also publishes a proposal for a new Regulation on in-vitro Medical Devices (COM 2012 541).

Details of the proposal can be found in the link below:

http://www.europarl.europa.eu/registre/docs_autres_institutions/commission_europeenne/com/2012/0541/COM_COM(2012)0541_EN.pdf

The proposal is currently under discussion in the Council. Again, it seems unlikely that an agreement will be reached before the Parliamentary elections this year.

15 January 2014

Published 14. April 2014 in News EU