EMA issues

Emerging matters – EMA

 Consultation request of EMA directly sent to EAHP

EMA, upon a request from PRAC, is seeking the views of patient representatives and healthcare professionals on awareness of DDS amongst patients and healthcare professionals.

Input of EAHP on the questions in the consultation document was requested.

Feedback should be provided by 1^st May

Agenda Healthcare professional working group

At the meeting in Cannes Ivana Silva mentioned that the agenda of the Healthcare professional working group is currently shaped. She suggested to us to provide our input at the next meeting in June.

The Board Meeting provides an opportunity to determine which EAHP priorities could be placed on the agenda of the healthcare professional working group.

  

Emerging matters – Commission

Medical Device Regulations

The Regulations for medical devices and for in-vitro diagnostic devices were approved by the European Parliament. They focus on the following aspects:

• Widening and clarifying the scope of the legislation, including for example, aesthetic implants and medical software;
• Ensuring a closer supervision of the notified bodies by the national authority;
• Offering more responsibility and authority to the assessment bodies, including regular checks on manufacturers and thorough testing;
• Clarifying the rights and obligations of the parties involved in the supply chain, covering also internet sales and diagnostic services;
• Ensuring transparency to patients and healthcare professionals through a database (EUDAMED) containing comprehensive information about the devices available on the EU Market;
• Introducing a Unique Device Identification system (UDI system) to ensure post-marketing surveillance and traceability;
• Implementing stricter requirements for clinical evidence;
• Adapting the safety and performance requirements to new health technologies;
• Enhancing coordination between national surveillance authorities and aligning to international guidelines to facilitate trade.

The upcoming step is the implementation of the legislation, which would be a gradual process ranging from 3 years for medical devices to 5 years for in-vitro diagnostic devices. Directorate-General Internal Market, Industry, Entrepreneurship and SMEs (DG GROW) is in charge of implementing the UDI system. This task will be carried out with the aid of an EU expert group on UDI that will assist in preparing regulatory acts/guidance related to UDI implementation.

The Board Meeting provides an opportunity to decide if EAHP should seek to become actively involved in the EU expert group on UDI.

 

MUNROS project

MUNROS ‘Health Care Reform: the iMpact on practice, oUtcomes and costs of New roles for health pROfeSsionals’ is a Seventh Framework Programme Collaborative project scheme funded by the European Commission. The project reached its completion in March 2017.

A systematic evaluation of the impact of ‘new professional roles’ on practice, outcomes and costs in a range of different health care settings within European Union and Associate Countries was undertaken> 

New roles analysed by the study include advanced nurse practitioners, pharmacists with extended roles (i.e. prescribing for chronic pain), physician associates.

Information on the final conference of MUNROS HERE

Health Improvement Scotland Composition presentation (including reference to role of pharmacist) HERE