Tech Trend

Medical Devices Regulation (EU) 2017/745 – MDR

On 5 May 2017, two new Regulations on medical devices were published, and they entered into force on 25th May 2017.  The Medical Devices Regulation (MDR) date of application is 26th May 2021 meaning compliance is mandatory to be able to place Medical Devices on the European market from this date.  In vitro Diagnostic Medical Devices Regulation (IVDR) applies from 26 May 2022.

Medical Devices Regulation (EU) 2017/745 will replace the current Medical Device Directive (MDD) and the Active Implantable Medical Device Directive (AIMD), whereas the IVDR will replace the In vitro Diagnostic Directive (IVDD). Both regulations bring a series of important improvements to conformity assessment for medical devices with the intention to:

  • Improve the quality, safety and reliability of medical devices placed on the European market.
  • Strengthen transparency of information related to medical devices for consumers and practitioners.
  • Enhance vigilance and market surveillance of devices in use.

The extent to which these changes will affect your operation will depend on the type of device manufactured and the role you hold (manufacturer, importer, authorized representative). It is however anticipated that in most cases significant changes must be made to compliance process and technical documentation and successfully implemented in operation before compliance with the regulations can be achieved.

See an overview of some of the key changes here.

Continued validity of current issued MDD Certificates

Notified Bodies, notified according to the existing Medical Device Directive may continue to issue certificates against these requirements up to and including 25th May 2020.  These MDD certificates will be valid until their original expiry date, or 26th May 2024, whichever is sooner.

This means that manufacturers can continue to put MDD certified devices on the market up to and including 26th May 2024, assuming they continue to keep these certifications valid. It is important to note however that after 26th May 2020 no significant changes may be made to MDD certified devices.  If a significant change is required, the device certificate must be migrated to MDR.

See an infographic of the transition timeline here.

Migration of MDD certified devices to MDR

The changes to the MDR and IVDR are often seen as a revision of the requirements, but in reality, it is a new regulation and should be treated as such.  In general, the concepts and the requirements of the MDD and IVDD remain part of the new legislation but significant additional requirements have been added and changes made.  There are a number of new requirements that manufacturers need to address before an application for certification to the MDR and IVDR can be made.

A new application for certification must be made by the legal manufacturer which will commence a new certification cycle, with validity up to 5 years.  Final details of the certification activity schedule will be made available soon, though manufacturers should expect to be required to successfully complete a Notified Body review of technical files (minimum one per product group) and an initial on-site audit activity to verify implementation before certification will be granted.  Sampling is not permitted for Class IIb implantable or Class III devices and manufacturers should ensure their technical files and design dossiers are MDR compliant prior to application.

DNV GL recognizes that available Notified Body capacity is limited and so will prioritize MDR Applications in the following order:

  1. Existing customers with MDD certificates expiring, based on expiry date.
  2. Existing customers with MDD certificates subject to significant change.
  3. New customers.

MDR Certification Process:

In order to support your migration to MDR, we have prepared the following visualization of the certification process and key information regarding the different types of activity.  Note: this is intended as an illustration, not an exhaustive list of requirements.

MDR Quality Management System Readiness Self-Assessment:

In order to support your migration to MDR with have prepared a free to use self-assessment tool. This tool is located on our Self-Assessment micro-site: https://ready.dnvgl.com/. Please send us an email at ready.support@dnvgl.com for free registration and access to this tool.

Please note: This MDR Readiness Self-Assessment checklist contains selected MDR requirements to be addressed by the manufacturer which are in addition to those defined in ISO 13485:2016. The purpose is to enable manufacturers to perform a readiness self-assessment of their quality management system.  This checklist has been developed as a free tool for the purpose of making a readiness evaluation of a quality system and not for determining or guaranteeing compliance to the MDR.

DNV GL MDR Designation update:

DNV GL Presafe and Presafe Denmark AS are two notified bodies within the DNV GL Group of companies.  In 2017 we announced that we would apply for MDR notification in Norway only (Notified Body 2460) to provide a more effective service for our customers by combining our global technical resources (over 140 specialists in over 20 countries) under one Notified Body system.

DNV GL is delighted to announce their Notified Body 2460 in Oslo successfully achieved designation by the Norwegian Health Authorities and the European Commission as a Notified Body for Medical Devices Regulation (EU) 2017/745 (MDR).  The designation was successfully granted for all technology types applied for, including the highest risk Class III devices, ensuring continuity of European market access for our customers’ life-saving medical technology.

In 2020 Notified Body 2460 intends to submit a further application for In-vitro Diagnostic Devices Regulation (EU) 2017/746 (IVDR) in order to also provide a global service for this rapidly growing sector.

Source:Medical Devices Regulation (EU) 2017/745 – MDR

Leave a Reply

Your email address will not be published. Required fields are marked *