MDR and IVDR Expert Guidance

Navigate the MDR/IVDR Transition

with BSI’s Compliance Navigator

MDR and IVDR Smart Support

Manufacturers are facing major and complex changes to the ways they currently manage compliance and, as a result, their manufacturing processes.

HELP IS AT HAND

BSI’s Compliance Navigator will be publishing topic by topic expert guidance briefs to help prepare for and navigate the transition.

GUIDANCE YOU CAN TRUST

Each topic will be written by an industry expert and reviewed by a topic expert, and advisory panel. Each piece of expert guidance will include:

An executive summary suitable for senior management
Detailed practical guidance on what has changed and what this means for your organization
Actions to take now and a summary of what is still to change

DON'T DELAY, MAKE SURE YOU'RE PREPARED

Guidance topics for 2017 include:

Clinical data requirements

- Clinical data

- Clinical investigation

- Clinical evaluation

- Identification and labeling

- Registration and traceability

Post-market surveillance
Classification changes

- Reclassifying class l to class lla and llb

- Reclassifying class lla and llb to class lll

Requirements for safety and performance
Authorised representative liability
Economic operators

- The role of the authorized representatives

- The role of the importer/distributors

- The role of assemblers of kits

Responsible person requirements

- Manufacturers

- Authorized representatives

Implementing and delegated acts, common specifications expert

MDR/IVDR Smart Support will be exclusively available to BSI Compliance Navigator subscribers. What’s more, over 300 harmonized standards will change as a result of the new regulations and Compliance Navigator will include every one, before and after the change and with alerts to keep you informed at every step of the development pipeline, so your business never misses a detail.