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Medical Devices Regulation (EU) 2017/745 - MDR

Medical devices

Notified Body 2460

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 2020 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 up-classified devices (such as Class Ir and Medical Device Software) which do not benefit from a grace period.
  3. Existing customers with MDD certificates subject to significant change.
  4. New customers.

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.

We were audited by the joint-commission in November 2018 and are in the process of designation.  We would like to assure our customers we have applied for MDR notification without any reduction in scope.  The commission has not communicated their notification schedule, however from observation of other ongoing notification timelines we expect to receive our notification in Q4 2019.

Next steps:

Once we have received confirmation of our MDR Designation from the Norwegian Health Authorities we will contact our existing customers to plan an orderly migration to MDR based on your individual circumstances and readiness for MDR.

Ota yhteyttä

Otto Hughes

Otto Hughes

Global Product Assurance Manager

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Resources:

Factsheet for Manufacturers

Medical devices change of legislation, find out what you need to know if you are a manufacturer.

Step by Step Guide for Manufacturers

Implementation model for medical devices regulation, download the step by step guide.

Factsheet for Authorised Representatives, Importers and Distributors.

For authorised representatives, importers and distributors of medical devices and in vitro diagnostic medical devices.

Factsheet for Procurement Ecosystem

For people within hospitals, clinics (or associations of clinics), ministries and competent bodies responsible for the procurement of medical devices and in vitro diagnostic medical devices.

Factsheet for Authorities in non-EU/EEA States

For regulatory/competent authorities in countries that are not part of the EU/EEA area.

Frequently Asked Questions

Notified Body legal entity for EU Medical Devices Regulation (MDR) 2017/745

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Answer
DNV GL Presafe AS (Notified Body 2460) is undergoing assessment to be Notified Body for EU Medical Devices Regulation (MDR) 2017/745.

Standard Rates for Audit & Assessment Activities

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Answer
The following fee structure applies for conformity assessment activities:
  • Audit
  • Assessment of Change Notification
  • Unannounced Audit
  • Assessment of Technical Documentation

Declaration of Interest of Top Management

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MDR Declaration of Interest

As reflected in our Purpose, Vision and Values, DNV GL Presafe AS, Notified Body 2460 is committed to the highest standards of business integrity, service quality and sustainability.

As a member of the DNV GL Group, we fully commit to DNV GL Group Code of Conduct.

All our employees perform their tasks with full respect to ethical and legal norms.

We are committed to adhering to, and actively advocating the principles of impartiality and independence. No employee of the Notified Body shall have any financial or other interest, directly or indirectly, in any business or activity which is of such a nature that it could throw suspicion on the impartiality of the employee or the Notified Body. The same is also true for the employee's close family members.

Our employees, including top management, and subcontractors do not have any remuneration arrangements that relate to the outcome of conformity assessment process or number of such processes.

We are not offering consultancy services in the field of medical devices. However, we are open for exchanges of technical information and regulatory guidance with manufacturers applying for conformity assessment.

Our certification services are equally available to any size of the enterprises and are based on a set of consistent, fair and reasonable terms and conditions defined by applicable laws and accreditation requirements.

Cecilie Gudesen Torp CEO of DNV GL Presafe AS

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