The Council Directive 2013/59/Euratom laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation (European BSS) introduces, in the medical field, specific articles relating to two important and complex areas:

  • Justification of medical exposures with respect to new types of practices and the interrelation with bio-medical research and early detection of diseases (art. 55 (2))
  • Accidental and unintended exposures of individuals subject to medical exposure focusing on specific requirements on notification and recording of significant events (art. 63 in conjunction with art. 96).

Member States have until the 6 February 2018 to complete the process of transposition into their national regulations.

HERCA organised two multi-stakeholder workshops in Paris on the transposition of these challenging issues in the medical field:

  • a Workshop on Generic Justification of Medical Exposures using Ionising Radiation (24 noon - 26 noon, October 2016)
  • a Workshop on Accidental and Unintended Exposures(26 noon - 27 October 2016)

The objectives of these two workshops were:

  • To explore a common understanding of the new BSS requirements
  • To exchange on national approaches relating to the implementation of these new BSS requirements;
  • To collect the opinion of important European stakeholders, particularly the European medical societies and manufacturers;
  • To assist in the development of HERCA Positions Papers intended to facilitate implementation of the BSS.

Institutional and health care professional stakeholders at European and international levels, as well as a patient representative organisation participated. 

Presentations

Workshop on Generic Justification of Medical Exposures using Ionising Radiation (24 noon - 26 noon, October 2016)

Introduction

Plenary session 1 - How can Health Technology Assessment (HTA) contribute to the justification process of new types of practices?

Plenary Session 2: How can CE Marking contribute to the justification process of new types of practices?

Plenary Session 3: Shall the regulator define a “Standard Medical Practice List “, in which all ICRP level 2 justified types of practice are listed?

Plenary Session 4: Shall the regulator link the justification process of new types of practices to the authorization process?

Plenary Session 5: Further approaches in MS for the transposition of Art. 55.2 (a) Council Directive 2013/59/Euratom and other articles around it

Plenary Session 6: Justification of new types of practices versus biomedical research?

Workshop on Accidental and Unintended Exposures(26 noon - 27 October 2016)

Introduction

Legal basis with respect to EU BSS Directive

Presentation and exchange on national approaches relating to definition and notification of significant events

HERCA discussion paper on accidental and unintended exposures and significant events

Feedback from European medical societies and from manufacturers

Experience feedback from event, reporting and learning - How to share experience?

Communication on accidental and unintended exposures: why and how?

INFORMATION

Venue - Access Map

Presentations

Workshop on Generic Justification of Medical Exposures using Ionising Radiation (24 noon - 26 noon, October 2016) (all presentations, zip file)

Workshop on Accidental and Unintended Exposures(26 noon - 27 October 2016) (all presentations, zip file)