The European Commission updated its “rolling plan” for adopting implementing acts and other actions/initiatives ahead of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
The update follows the delay of implementation of the MDR by one year amid COVID-19 and the decision to postpone Eudamed’s rollout by two years last December.
The plan is divided into two sections: implementing acts, and other actions/initiatives.
The part Implementing acts contains following subjects:
- Notified bodies scope of Designation
- Reprocessing of single-use medical devices
- Common specifications for products without a medical purpose
- Setting up of expert panels
- Setting up of expert laboratories
- Setting up of new structures under IVDR: – EU reference laboratories
- Rules to facilitate fulfilment of tasks by EU reference laboratories and to ensure their compliance with criteria
- Fees for EURL services
- Unique Device Identification (UDI) System: designation of issuing entities
- EUDAMED
- Common specifications for IVD Class D
The part Actions/initiatives (other than implementing regulations/acts) contains following subjects:
- Notified Bodies designation
- EUDAMED go-live
For more information, please see the original Implementation rolling plan document from European Commission or download it from the EC website.
Meditrial can help – Contact us for immediate support
Meditrial has developed rapid workflows to conduct risk assessment, implement rescue plans and execute solutions for ongoing clinical trials:
- Identify patients requiring follow-up
- Conduct investigator and study nurse calls for training to address the situation
- Obtain authorizations for decentralized data collection
- Support to patients for alternative access to needed care
- Prepare procedures and worksheets for remote collection of patient clinical data
- Monitor work instructions and trainings for site support and remote monitoring
- EDC and ePRO solutions to enable study continuity
- Privacy protection measures
Contact Meditrial for immediate assistance in Europe or the US.
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