- Review and Assess the Client’s entire Product Portfolio including its:
- Legacy Products [CE marked devices under the Medical Device Directives (MDD) 93/42/EEC or the Active Implantable Medical Device Directive (AIMD) 90/385/EEC];
- Modified Legacy Products; and/or
- New Products currently in the Design/Development Phase.
- Confirm whether any Legacy Products and/or Modified Legacy Products have been affected by the new MDR Definitions and/or Reclassification of certain types of products into higher risk classes of devices;
- Reassess current classification of devices based on MDR Classification Rules;
- Prepare Product Rationalization Strategy Reports for Legacy Products, Modified Legacy Products, and New Products (as appropriate and applicable). which may assist the Client in making internal decisions about whether to maintain and/or bring such products in compliance with the MDR;
EU MDR Regulation Services
The EU Medical Device Regulation (MDR) was published in the Official Journal of the European Union on May 5, 2017 and became the current regulatory standard on May 26, 2021. The EU MDR replaces the Medical Device Directive (MDD) [93/42/EEC] and the Active Implant Medical Devices Directive (AIMD) [90/385/EEC].
The Transition Period began in 2017 for medical device manufacturers selling medical devices into Europe and continues today based on the medical device class for each regulatory submission. Regulatory Compliance Associates® can assist clients that need to comply with the EU MDR requirements with the following services:
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