In an attempt to make this complex subject easier, not just to grasp, but also to implement the regulatory requirements, manufacturers of medical devices should plan carefully and perform process management to ensure compliance and patient safety.
Europe is experiencing a major overhaul, as the new EU-MDR and In-Vitro Diagnostic Regulation (IVDR) revoke existing directives on medical devices. The predecessors – the Medical Device Directive (MDD [93/42/EEC] and Active Implantable Medical Devices Directive (AIMDD [90/385/EEC]) – had innate imperfections and were not able keep up with rapid modernization in technology and medical sciences. This prompted the European Commission to introduce urgent reforms to improve consistency, traceability, and transparency in regulatory processes and monitoring of post-market performance.
With the MDR transition deadline getting close, it is imperative that manufacturers adopt a strategic approach to addressing the complexities of the new regulatory environment and accelerate implementation of new requirements.
[** The updated deadline for MDR compliance is May 2021. Please note that due to the COVID-19 pandemic these timelines are subject to change.]
Changes in the new MDR regulation
The major change in the new MDR regulation is the lifecycle approach being adopted. This approach is similar to the lifecycle view advocated by the US FDA and advanced by many international standards. Other changes include device reclassification, updated post-market surveillance requirements, general safety and performance requirements, clinical evaluation requirements, introduction to UDI (unique device identification), and EUDAMED (EU databank on medical devices) for all.
These processes also require broader quality management systems (QMSs). The key processes in the QMS are risk management, usability engineering, clinical investigations/evaluations, and post-market surveillance.
Key considerations for the successful implementation of the MDR regulation
The compliance process for the new regulation may call for major changes in the manufacturers’ processes for various product lifecycle processes. For this reason, manufacturers should invest in training programs, and learn about the new process changes, templates, and standard operating procedures (SOPs) that need to be updated.
It is also important to monitor any common specifications, harmonized standards, and guidance documents that are released (as those require compliance as well), and look out for any newer versions.
For legacy devices, the most important thing is to check whether the device has been up-classified. If so, requirements for new classification need to be implemented. There are some extremely valuable legacy products with strong market acceptance, but the cost of compliance may not be justifiable. Due to updated requirements, if any significant changes are needed in the device design, labelling, packaging, etc., the notified body has to be informed. Also, updated requirements to provide clinical evaluation data as technical documentation may call for additional clinical data. This can be time consuming and costly.
Manufacturers should look for more automated frameworks and solutions for easier compliance with the lifecycle approach. There are tools available for QMS, document management and compliant handling that can make sure manufacturers are “audit ready” for announced as well as unannounced audits as per the new requirements.
For the smoother transition to MDR, certain considerations need to be taken into account:
- Process redesign
- QMS compliance
- Post-market surveillance process changes
- Risk management process changes
- Product testing/gathering clinical evidence
- Process management and governance
- Supply chain compliance
- Notified body interactions
- Process automation
- Integrated framework to enable traceability.
MDR timelines are getting close and we need to adopt them as soon as possible in order to sail through this journey smoothly. Updated MDR requirements need thorough review, planning, and enough time to be put in place for remediation. Organizations should take a structured approach to ensuring proper planning and management, training, allocation of skilled resources and budget, and the use of process automation.
Regulatory changes are an effective step towards enabling the Intelligent Industry, read our point of view to learn more about Capgemini’s framework for a successful transition to MDR and each of the key considerations in detail.
|Manasi Kulkarni is a QARA specialist and a certified ISO 13485 auditor, working with Capgemini’s Digital Engineering and Manufacturing Services. She has an engineering background with strong experience in project management and QARA for medical devices. She has been actively working on knowledge sharing for process standards and new EU-MDR regulation within the organization and providing solutions for regulation compliance for the medical device customers.|