MDR & IVDR –
The final text of the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) have been available since Feb 2017, which are intended to replace the current EU regulatory framework for medical devices consisting of Medical Devices Directive 93/42/EEC and Active Implantable Medical Devices Directive 90/385/EEC.
All medical devices will need to be certified under the MDR. The MDR requires manufacturers to demonstrate an effective QMS. Certification to ISO 13485:2016 facilitates the organization to achieve above compliance. If a contract manufacturer does not take legal manufacturer responsibility, it may be subject to audits on behalf of the associated legal manufacturers, including unannounced audits.
Anticipated Key Changes to MDR
- Scope extended to non-medical devices
- Common Specifications
- Rigorous post market surveillances with periodical updates
- Unique device identification
- Eudamed database for transparency
- Scrutiny mechanism for conformity assessments
- Classification rules changes for certain devices
- Stricter requirement on clinical data
- Safety and performance requirements in replacement of Essential Requirements
- Specific instructions on device technical documentation
- Identification of “qualified person”
After the official publication of MDR / IVDR, estimated in Q2 2017, there shall be a 3-year transition period. Manufacturers will have the transition period to apply for certification under the MDR/IVDR for devices currently certified under the Medical Devices Directive (MDD).
Certificates issued to the MDD during the transition period will remain valid for the entirety of their certification period (no longer than 5 years), unless that exceeds four years after the date of application. If your MDD certificate expires without new certification to MDR/IVDR during the transition period, you will have to remove products from EU market.
Notification Body – DQS
Besides an accredited certification body for ISO 13485:2016 and authorized Audit Organization (AO) for MDSAP, DQS is currently one of few authorized Notification Bodies for medical devices and CE marking. For the service that DQS can provide as a Notification Body, contact DQS-HK for details.
Training by DQS
DQS Academy provides ISO 13485:2016 Internal Auditor Training and ISO 13485:2016 Lead Auditor Training courses, to help clients get the required knowledge for medical devices QMS implementation, which will facilitate the organization to achieve compliance to MDR and IVDR.