"I appreciated that the representatives I worked with at Oxford quickly understood the type of skills I was looking for and understood my sense of urgency." 
- Regulatory Manager

To ensure your organization meets the MDR transition deadlines, partner with Oxford. Whatever your requirement, we will provide a customized solution to meet your needs. 

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In May 2017, the European Commission voted to approve new Medical Device Regulations (2017/745). This is one of the most significant updates of the regulations that govern medical devices in Europe in recent history. This impacts all companies marketing devices in the EU that wish to continue doing so. 

The transition to the new MDR can be overwhelming if you do not have the resources required to support it. This is where Oxford can partner with you! 

Through our established network of compliance experts within the device sphere, we can support clients of all sizes – from start-ups to multinational market leaders. We can provide staffing and consulting support for every stage of the MDR compliance transition process.

  • Compliance experts in medical devices, ISO 13485 and 14971 and the newly published MDR
  • Experts in Technical File and CER compilation for all classes of medical devices
  • Specific device product knowledge from Orthopaedic to Cardiovascular, Drug Delivery, Software Devices and IVDs
  • Lead auditor consultants who have held senior positions for notified bodies and regulatory agencies such as the FDA
  • Consultants who have held manager and director level positions for many of the major manufacturers within medical devices

Oxford's Experts

What Are the New Medical Device Regulations (MDR)

The new Medical Device Regulations (2017/745) approved by the European Commission in May 2017  will necessitate widespread changes in how devices are manufactured and the level of compliance and clinical data required to bring them to the European market.  

All medical device organizations that serve the EU market need to consider how they will transition in time to meet the required MDR compliance deadlines. This will require drafting a transition plan for each of your devices and for your organization as a whole, and then dedicating the resources needed to fulfil the new requirements.

  • More effective Post Market Surveillance requirements
  • More detailed requirements and clinical evidence for Clinical Evaluation Reporting
  • QP type Responsible Person for product release must be designated for manufacturers
  • Increased level of compliance for UDI & labelling
  • Distributors & importers must now be regulated (MDR Arts 11-14)
  • IVD risk-based classification leading to many more devices falling under Notified Body scrutiny

Key Changes

Oxford's MDR Process

Support for Your Medical Device Regulation Compliance Transition 

Support for Your MDR Compliance Transition

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Oxford MDR Key Dates to Remember
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To ensure your organization meets the MDR transition deadline, partner with Oxford for all your staffing and consulting needs. 

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