From OT Europe

Prepare for the Medical Device Regulations Session

EFORT

EFORT believes that robust regulation to ensure a supply of safe devices and to monitor the introduction and use of devices in practice is essential.

The Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation published in May 2017 permitted 3- and 5-year transition periods to allow new regulatory systems to be set up. During this time, new notified bodies need to be designated and established ones re-designated, 18 system-critical acts (as identified by the European Commission as mandatory) must be published and interpreted, and the appropriate infrastructure has to be established to allow the regulations to be implemented. This includes the establishment of expert panels and reference laboratories, the agreement of common specifications and the publication of standards and guidelines that would allow uniformity in the interpretation and application of the regulations.

EFORT is concerned that if full achievement of the aims and objectives of this legislation is not reached by the end of the transition period, which is rapidly approaching, not only will the introduction of improved devices be impacted, but also the necessary review of all devices currently in use will not be complete. This could result in non-availability or even withdrawal of implants and devices currently in widespread use.

Further, in the third week of November, a large collective of journalists published articles about the safety of surgical implants in Europe. In newspapers, as well as on television, they criticized the safety of some of the implants. They also criticized the process used in Europe for evaluation of implants before they are allowed onto the market.

In a letter issued by MedTech Europe, it is questioned how the new regulation attempts to provide some relief to the system through a “grace period” and a “warehousing” clause will finally affect their initial objectives

From these considerations made by health care professionals as well as messages delivered directly to patients, EFORT wishes to create a discussion forum during the annual congress through an “MDR Session” which is scheduled for 7 June at 13:00. Educating and informing health care professional on these new regulations and bridging the gaps between involved parties, such as medical associations, EU and national regulators and the medical device industry is a primary objective of this session.

Those who attend will also learn more about:

  • how to regulate a disparate area of hundreds of thousands of devices — a system that works for a wheelchair or a heart valve;
  • whether re-evaluation of progress is possible at this stage; and
  • what the possible impact of a “grace period” and a “warehousing” clause may be.
EFORT

EFORT believes that robust regulation to ensure a supply of safe devices and to monitor the introduction and use of devices in practice is essential.

The Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation published in May 2017 permitted 3- and 5-year transition periods to allow new regulatory systems to be set up. During this time, new notified bodies need to be designated and established ones re-designated, 18 system-critical acts (as identified by the European Commission as mandatory) must be published and interpreted, and the appropriate infrastructure has to be established to allow the regulations to be implemented. This includes the establishment of expert panels and reference laboratories, the agreement of common specifications and the publication of standards and guidelines that would allow uniformity in the interpretation and application of the regulations.

EFORT is concerned that if full achievement of the aims and objectives of this legislation is not reached by the end of the transition period, which is rapidly approaching, not only will the introduction of improved devices be impacted, but also the necessary review of all devices currently in use will not be complete. This could result in non-availability or even withdrawal of implants and devices currently in widespread use.

Further, in the third week of November, a large collective of journalists published articles about the safety of surgical implants in Europe. In newspapers, as well as on television, they criticized the safety of some of the implants. They also criticized the process used in Europe for evaluation of implants before they are allowed onto the market.

In a letter issued by MedTech Europe, it is questioned how the new regulation attempts to provide some relief to the system through a “grace period” and a “warehousing” clause will finally affect their initial objectives

From these considerations made by health care professionals as well as messages delivered directly to patients, EFORT wishes to create a discussion forum during the annual congress through an “MDR Session” which is scheduled for 7 June at 13:00. Educating and informing health care professional on these new regulations and bridging the gaps between involved parties, such as medical associations, EU and national regulators and the medical device industry is a primary objective of this session.

Those who attend will also learn more about:

  • how to regulate a disparate area of hundreds of thousands of devices — a system that works for a wheelchair or a heart valve;
  • whether re-evaluation of progress is possible at this stage; and
  • what the possible impact of a “grace period” and a “warehousing” clause may be.