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Medical Devices Regulation (EU) 2017/745

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 date of application is from 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 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, authorised 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.  

Download the key changes here.

MDD Recertification or MDR Initial Certification – The key choice facing manufacturers in 2019

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. From 26 May 2020, any publication of a notification in respect of a notified body in accordance with Directives 90/385/EEC (Active Implantable Medical Devices) and 93/42/EEC (Medical Devices) shall become void. These MDD certificates will be valid until their original expiry date, or 26th May 2024, whichever is sooner. This means that manufacturers could continue to put MDD certified devices on the market up to and including 26th May 2024, assuming they continue to keep these certifications valid. As the requirements for MDR are in many cases, significantly more onerous than MDD, we expect that manufacturers with MDD expiry dates in the first years after applicability of MDR will decide to re certify out of normal cycle to maximise market access time according to the current MDD requirements. 

View the transition timeline infographic here.

Designation update:

DNV GL Presafe AS (Notified Body 2460) has applied to be designated as a Notified Body in Norway under Medical Device Regulation (EU) 2017/745 with the same scope as our existing MDD designation. In November 2018 we completed our audit from the Norwegian Medicines Agency and Joint Assessment Team. The European Commission has not yet announced its plans for designation timelines and we will update this information as soon as this becomes known.  

 

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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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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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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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