Overview of Medical Device Regulation

What is the European Union's New Medical Device Regulation (MDR)

European Union Medical Device Regulation (MDR) 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).

Background- Why is the MDR is being implemented?

The background work for the 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 implementation 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 Implementation and Certification Timelines.
The MDR is expected to come into effect by early May 2017. Read More >>>

Impact analysis of the Expected changes:
The proposed Medical Device Regulation (MDR) draws up several changes that the Medical device industry awaits and manufacturers need to look at the regulation in minute detail to exercise their responsibility and demonstrate compliance for placement of devices in the market and provide a safe and effective device throughout its lifecycle.

Extension of scope to Non-medical devices
The new Medical Device Regulation is expected to broaden the scope of the medical devices and active implantable devices. 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.

Increased accountability of Authorised representatives
With the new Medical Device Regulation the responsibility of Authorised representatives increases to monitor their Client activity to ensure compliance as they will also be held liable for faulty medical devices. This would give rise to additional perusal and inspections by the Authorised representative.

Relook at the classification of devices
Manufacturers would need to relook at the Classification rules as set out in the Annex VII taking into account the Invasiveness, Contact duration and inherent risks involved. Additional classification rules have been included in the new MDR Classification. Read More >>>

Stringent clinical evaluation
In case of class III devices and active implantable devices, a clinical investigation would need to be undertaken if proper clinical evidence of safety and performance is unavailable. All manufacturers need to relook at their clinical evaluation documentation considering when an equivalence determination can be utilized and a clinical investigation be avoided. This exercise needs to be conducted keeping the MEDDEV 2.7/1 Rev 4 as an integral part, to demonstrate compliance to the New Medical device regulations.

Implementation of UID
In an effort to increase the Traceability and identification of medical devices, all devices will now possess a unique Identification number that tracks the device from manufacturing to the end user. The UDI code must be made available on labels of the devices and will become a coherent unit of the EUDAMED Database. Additional information on the UDI can be obtained from the Annex V of the MDR.

Technical file requirements
The MDR Annex II lists and describes in detail all the documents that need to be made available in an organized searchable format. This should include

  • Device description and specification
  • Information supplied by the manufacturer
  • Design and manufacturing information
  • Safety and Performance Requirements
  • Risk/benefit analysis and risk management
  • Product verification and validation (including preclinical and clinical data).
  • Additional requirements on the technical documentation regarding Post market surveillance is provided in the Annex IIa.

Changes In Medical Device Regulation (MDR) Essential requirements. Read More >>>

Impact on the Notified Body
Considering a higher and stringent scrutiny of the notified Body by the Competent authorities it is expected that the manufacturers must undergo stricter evaluation and additional unannounced audits and more review comments and provision of additional information during the review process itself. It is advisable that manufacturers analyze and plan their go to market strategies and evaluate the capability of the notified body to withstand such scrutiny.

Medical Device Regulation Mapping

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EUDAMED Database
European Databank on Medical Devices (EUDAMED) as given in the new regulations will act as a database in providing comprehensive information on the devices placed in the European Market to the public, Healthcare professionals and the Patients. Majority of the data will be made accessible to the public keeping the data protection needs under watch. It is notable that all class III and implantable devices need to write up a clear summary of safety and clinical performance and make it available on the EUDAMED after review with the Notified Body.

What Next and How we help you to overcome.
Prior to the final adoption of the 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 I 3 CONSULTING for implementation and compliance.

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