Ready for the new Medical Device Regulation on May 26th 2020?

May 5th 2017
Decision
Adoption of the Medical Device regulation through the European Parliament
Decision
May-June 2017
Start
The Medical Device Regulation comes into effect
Start
2017 - 2020
Transition time
Transition time, where medical devices can be certified according to the old and the new law
Transition time
May 26th 2020
Obligation I
EG-Certificate will become mandatory for medical devices brought in traffic for the first time
Obligation I
2024
Obligation II
EG-Certificate will become mandatory for all medical devices brought into use. (Old certificates can be ex- tended by up to four years within the transition time. The old certificates will expire no later than 2024)
Obligation II

  • You are required to establish new quality processes to ensure the safety of your products

  • You are required to set up an appropriate system to monitor the post-market-performance of your products

  • You are required to install a risk management system which has to contain the information you gained through your post-market-surveillance

  • You are required to provide the patient with as many information as possible about your product, possible side effects and alternatives

New Regulations enforcing post-market surveillance

Update the
clinical evaluation

Detect
& Report

Preventive, corrective
or field safety
corrective action

Up to date
post-market
surveillance system

Patient-Reported-Outcome

How will manufacturers collect patient-reported-outcome data from as many users as possible with reasonable cost and effort?

CAREONLINE is your best solution

More Features for CAREONLINE medtech


PRO Questionnaire

Threshold Management

Medication Plan

Task & Education Management



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