11/04/2015

Obelis SA Obelis European Authorized Representative Center

Europe moves forward on New and Emerging Technologies

The New and Emerging Technologies (NET) Working Group is following all the new and emerging technologies, and their impact in the field of medical devices at EU Commission level.


The main activities of the working group are:
•Identifying new and emerging technologies in the area of medical devices;
•Considering the adequacy of the existing devices regulatory regime in relation to those technologies and, where shortcomings are identified, making recommendations to the Medical Device Expert Group to solve them by through guidance or regulatory change;
•Commenting on relevant issues in connection to new and emerging technologies in other areas, as far if they affect medical devices.


The members of this working group work for Commission services, National Competent Authorities, EU associations of Industry including the European Association of Authorized Representatives, patients, health professionals, notified bodies and the European Standardisation Organisations. It is for the Authority of each Country and the other stakeholders to decide on who will represent them. The Commission invited the most important EU Associations dealing with medical devices as well as the EFTA and the candidate countries to be part of this group.


The main points discussed during the last meeting on the 28th May were:


Nanotechnologies


The NET worked on nanomaterials in the past, and this was fed into the Commission’s considerations; consequences related to the combination of the adopted definition of nanomaterial and Classification Rule 19 of the Proposal of the new Regulation of Medical Devices have been discussed.


Industry associations did indicate that most medical devices may be subject to Rule 19 according to the provisions in the 2012 proposal, because presence of nanomaterials in trace amounts cannot be excluded and testing all medical devices to exclude release was considered practically impossible. NET will prepare a report summarising the results.


3D-Printing


A new Special Interest Group was installed on this topic. The group will investigate the impact of 3D printing technology on medical device development and production and on regulatory pathways for approval of 3D printed medical devices (both custom and non-custom-made).


Remote monitoring/self-monitoring


The Special Interest Group on eHealth is analysing a number of technologies with special monitoring/self-monitoring features, ranging from glucose levels to performance of a wearable artificial kidney.


Horizon scanning of new technologies


Developments identified as important for the medical devices area, and (potentially) challenging both the current and the future regulatory framework include exoskeletons integrated with neural system, robotic surgery using artificial intelligence, real time imaging during surgery, wearable sensors for diagnostic purposes, brain stimulation, companion diagnostics and in situ tissue engineered heart valves.


WORK PROGRAMME FOR 2015
•Analysis of above mentioned developments.
•Further develop horizon scanning methodology using specialised software and by using key sources of other horizon scanning organizations.
•Keep scanning the horizon for relevant new technologies. Assess any newly identified technologies with regard to their compatibility with the regulatory framework, and report to MDEG when relevant.


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