EU Medical Devices Regulation

Since decades, regulation of the medical device industry in Europe has been rather unchanged. However, recent events have now prompted for vital regulatory & compliance reforms to the medical devices industry. The new Medical Devices Regulation adopted by EU, replacing the two existing directives, the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive.

To meet the new EU MDR objective, organizations will need to take a structured and well-managed approach over the next 3 years depending on the product portfolio.

MDR Timeline

Key changes

  • Expansion of products that are covered under Medical devices and Active Implantable Medical Devices that may not have medical intended purpose.
  • Stricter control for high-risk devices via a new pre-market scrutiny mechanism with the involvement of a pool of experts at EU level.
  • Reinforcement of the criteria for designation and processes for identification of Notified Bodies.
  • MDR mandates the use of Unique Device Identification for improved transparency to enhance the ability of the manufacturers and Health Authorities to trace specific devices through the supply chain, and to facilitate the timely and efficient recall of medical devices those found to present a safety risk.
  • Reinforcement of the rules on clinical evidence, including an EU-wide coordinated procedure for authorization of multi-center clinical investigations.
  • Strengthening of post-market surveillance requirements for manufacturers to reduce risks from unsafe devices
  • Improved coordination mechanisms between EU countries in the fields of vigilance and market surveillance.

We offer support in the following areas:

Regulatory Strategy
Building up the ideal Regulatory strategy depending on the device and market you need to enter

Clinical Evidence
Full service clinical evidence programs from advisory to implementation involving Retrospective/ EMR data, Chart Review and setup of registries

MakroCare reviews data to discover the gaps in compliance and provide a plan to address those

Post Market Support Activities
Support PMS with formalizing a plan for aggregate reports process creation to standardization of templates ans required technology for you to stay compliant

UDI Setup
MakroCare advices in setting up UDI program along with required software

Vigilance & Medical Device Report
MakroCare supports with reporting incidents and field actions in the US, Europe and other markets

Have Questions? Need Info/Quotes?

Have Questions? Need Info/Quotes?