The new Medical Device Regulation has been postponed by a year, however, the regulation is still coming and all medical device companies will be eventually expected to comply with it in order to keep the sales continuity in Europe. It’s certainly wise for companies to invest the time in understanding the differences between the MDD and MDR and have a plan in place to ensure the transition is completed timely.
Here are some worth noting differences between MDD and MDR:
- MDR includes, within its scope, medical devices and Active Implantable Medical Devices (AIMD) and shall replace Medical Device Directive (MDD) and Active Implantable Device Directive (AIMDD); whereas In Vitro Device Regulation (IVDR) shall replace In Vitro Device Directive (IVDD).
- In comparison to MDD, the MDR is far more exhaustive and contains five additional annexes.
- The MDR laid more emphasis on safety which can be inferred by the fact that the term ‘safety’ in the new regulation is seen almost 293 times as compared to MDD where it is only 24 times.
- All incidents, injuries and deaths should be reported under Periodic Safety Update Reports (PSURs) by the manufacturers to the centralized EU portal so that the public can access the data with ease. Any non-death events and non-serious events can be reported within 30 days, instead of 15 days as per previous MDD rules.
- The MDR has increased focus on the area of investigation and post marketing follow-up. This will improve transparency better than that in MDD.
- Detailed clinical data or information to support the safety performances of the devices are mandatory under the MDR rules.
- A major change by MDR and IVDR has been witnessed in relation to the role of supervision of the Notified Bodies (NBs) who are designated to check the compliance of the device. NBs will have to consult with the European Commission (EC) on surveillance assessments and clinical evaluations. There are multiple requirements now for the Notified Bodies, and only some would qualify to certify under the MDR, as opposed to numerous NBs that exist for MDD.
- Earlier, the EUDAMED database used to only store data related to the registry of manufacturers, authorized representatives and devices, declaration of conformity, and data on incidents or near-incidents during the use of medical devices. But the transition to MDR will facilitate the storage of additional information, such as Post Market Surveillance (PMS) activities, safety and performance-based clinical studies and PSUR.
- The MDR fosters accountability in the medical device industry’s stakeholders by extensively laying out the responsibilities. Hence, the term “Economic Operators” which includes –
- Authorized Representative; And their responsibility includes –
- EUDAMED Registration
- Technical Documentation
- Design and Development
- Complaint Handling
- Storage and Distribution
- UDI Labeling
- Corrective Actions
- Post Market Surveillance
- Regulatory compliance
- MDR will allow better traceability of all medical devices through a unique coding system, the Unique Device Identification (UDI).
- There will be re-classification of certain devices which may now, as per the MDR, fall in higher-risk classes, hence would need to have robust clinical validation and additional information in place to be compliant to the EU regulatory requirements.
- Based on the classification framework proposed in the MDR, non-medical and non-regulated cosmetic devices, such as contact lenses, liposuction equipment, or epilation lasers and products for cleaning, disinfection or sterilization of devices, will come under the scope of the MDR. y
Most of the legacy devices CE marked under the MDD will require recertification because of Annex I, General Safety and Performance Requirements (GSPR).
As you see there are many new terms and requirements; the new regulation will need companies to further adjust their portfolios, especially if they are selling in more than one country. To remain compliant, they need to perform a global impact assessment which can help them in implementing the necessary changes and ensuring that the implemented changes for the MDR do not impact compliance for other countries. Since the COVID outbreak has delayed the MDR, this time can be better utilized by the medical device manufacturers in identifying the gaps and making correction strategies to make a robust MDR transition compliance plan. Contact Elexes or email firstname.lastname@example.org for more information.