MDR 2017-745

Medical Device CE Marking and new MDR 2017/745

EU Medical Device Regulation is the new regulation that makes its way after negotiations between the European Commission, European Parliament and the European Council.

This Medical device regulation replaces the Medical device Directives (93/42/EEC) and the Active Implantable Devices Directive (90/385/EEC).

The background work for the EU MDR by the European Commission dates back to 2012 when a plan to restructure the Regulatory Framework and revise the existing regulations was laid down.

The new regulation was first read out in the Parliament in 2014 and the final text was available in June 2016. After the current works of translation into the official European Languages it is expected that the MDR will be available for application by May 2017.

The overall objective of the MDR CE Marking has been to ensure high level of protection of human health and safety and to provide a framework that is Conducive for the Innovation and competitiveness of the European medical device Market.

MDR CE Marking Process >>

The EU MDR Medical Device CE Marking draws up several changes that the Medical device industry and manufacturers need to look at the regulation in minute detail to exercise their responsibility and demonstrate compliance for placement of devices with CE Mark in the market and provide a safe and effective device throughout its lifecycle.

Extension of scope to Non-Medical Devices; The new EU Medical Device Regulation has broaden the scope of the (active /nonactive) Medical Device CE Marking.

The additional list of devices is listed in the Annex XV of the MDR which would include devices that do not currently have a Intended medical purpose such as contact lenses, Surgically invasive products to alter the anatomy, Liposuction and other such equipment, High intensity electromagnetic equipment such as tattoo, hair removal machines, Products substances for filling such as breast implants.

The MDR also includes devices used for cleaning, disinfection and sterilization of medical devices.

Major Changes in MDR Medical Device CE Marking

  • Increased accountability of European Authorised Representatives
  • Stringent Clinical Evaluation
  • More Technical Documentation Requirements
  • EUDAMED Database
  • Implementation of UID
  • New classification method

Medical Device MDR article 2 definition

The definition of medical device CE Marking is provided in MDR 2017/745, Article 2. The following devices fall article 2 definition for example:

  • General use medical devices (Sterile and Non-Sterile)
  • Active Medical Devices
  • Non-Active medical device
  • Implantable Medical Devices
  • Medical equipment and machinery
  • Home Healthcare Devices
  • Software as Medical Devices (SAMD)
  • Active Implantable Medical Devices

MDR 2017/745 PDF File Download >>

CE Marking Request For Quote >>

PMS procedure

How to overcome new MDR Medical Device CE Marking obstacles.

Prior to the final adoption of the EU MDR, it is still uncertain of all the changes that are expected and bound to happen and this would turn out to be a time consuming, complex process for all medical device manufacturers. So, it is advisable that you keep yourself updated and aware of the upcoming changes and its impacts on your device and seek expert technical advice from MedDeviceCorp for implementation and compliance.

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