Emergency Line: (002) 01061245741
Mon - Fri: 8.00am - 7.00pm
  • info@omcmedical.co.uk

Get In Touch:

Get In Touch:

  • info@omcmedical.co.uk
Youtube Linkedin Facebook Instagram
Call Us Now:
+44 2080667260 sales@omcmedical.com

Albania

Austria

Azerbaijan

Belarus

Belgium

Ireland

Netherlands

Russia

Spain

Ukraine

UK

European

Home
European

European Union: EU-MDR

The new European Union Medical Device Regulation (MDR 2017/745) brings significant changes to previous regulations. The EU adopted the new Medical Device Regulation, replacing the two existing directives, the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive. Device manufacturers who market products in the EU must be ready to meet the May 26, 2021 transition deadline (delayed from 2020 due to the coronavirus pandemic). OMC Medical assists manufacturers to build a structured and well-managed approach to meet the new EU Medical Device Regulation objective depending on the product portfolio.

EU-MDR Key changes:

Albania
Austria
Azerbaijan
Belarus
Belgium
United Kingdom
Bulgaria
Estonia
Finland
Greece
Hungary
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Russia
Serbia
Slovakia
Slovenia
Spain
Sweden
Switzerland
Turkey
Ukraine
Bosnia & Herzegovina

EU-MDR Key changes:

  • Expansion of products covered under Medical Devices and Active Implantable Medical Devices may not have a medical intended purpose.
  • A UDI device identifier (UDI-DI) and a UDI production identifier (UDI-PI) will be required on all products placed on the EU market, except for custom-made devices and investigational devices.
  • EUDAMED will consist of several integrated electronic systems. It will be used to collect and process information relating to devices in the EU. It will allow for better access and exchange of information between the public, health care professionals, notified bodies and member states.
  • Reclassification of many medical devices to a higher risk class and a new classification for reusable surgical devices requiring notified body oversight.
  • Manufactures will need to assign a Person Responsible for Regulatory Compliance with relevant experience in medical devices and regulatory affairs/quality management systems within their organisation.
  • EU MDR introduces a new requirement to produce a PMS Report or, depending on the device class, a Periodic Safety Update Report (PSUR) in addition to Post market survillance plan
  • EU-MDR requires that all regulated medical device content be available in the local languages of the Member States where the devices are distributed.
  • Manufacturers will need to generate and provide more in-depth clinical data to prove safety and performance claims including tighter equivalency standards.

EU-MDR Key changes:

  • Technical Document Compilation (Technical Files)
  • Labelling & Packaging requirements
  • EUDAMED registration assistance
  • UDI Setup
  • Regulatory Documents Translation: – Translate User Manual, Brochures, Labels, Technical File for all official EU Languages
  • Local listing within the EU
  • Post Market Support Activities
  • Clinical evaluation documentation
  • Risk management Studies
  • Regulatory Strategy: Expertise on all regulatory strategies with the new device or device changes, upgrades, revisions to get compliant with EU-MDR Regulatory Gap Analysis EU MDD to EU MDR

Enquiry Now

    This will close in 0 seconds