3. Gap analysis and strategy finalization for compliance

Classification and Up-Classification

• Classification and up-Classification of the devices as per new EU MDR classification rules
• Classification of non-medical devices/accessories as per new EU MDR classification rules

Impact Analysis and Gap Assessment

• Overall impact assessment of the new regulations on the product (Quality/Clinical/QMS)
• Transition plan for recertification of devices as per the new EU MDR (Including re-classified devices)
• Identification of additional requirements for re-certification as per the new EU MDR
  Assessment of OEM/OBL requirements of technical file (OEM: original equipment manufacturer; OBL: Own Brand Labeler)

Technical File Compilation

• Compilation of technical file as per new EU MDR regulations (Including for the accessories/non-medical/software devices/high risk)
• Amendment of technical files for software in accordance with requirements for higher risk class
• Gap analysis of consequences of changed essential requirements and compilation of safety and efficacy summary

Regulatory Support for Recertification Under New MDR

• Identification of Notified Body for certification under New EU MDR
• Certification of new devices under New EU MDR
• Re-certification of existing devices and re-classified devices under New EU MDR
• Regulatory strategy for handling of queries from Notified bodies

UDI Implementation

• Required for the product right from the submission of application for CE certificate
• Identify the UDI agency for the manufacturer
• Compilation of the UDI requirements for application
• Regulatory strategy on the change of UDI for modifications of the product to manufacturer

Global Regulatory Impact Analysis of the Product Registration

• Regulatory intelligence on the impact of the re-certification on global markets where the product is registered based on European certification
• Regulatory strategy and approach to continue the registration status of the product active global markets

Conclusion

Despite evolving guidelines and interpretations of the new medical device regulations in UDI, EUDAMED, Medical device co-ordination group (MDCG), General Safety and Performance Requirements, Common Specifications, the new EU MDR imposes adherence to tighter safety and efficacy requirements. This raises the bar for regulatory evaluation and certification on par with the unimaginable progression of the medical science innovation. Manufacturers should assess the impact of these changes early during R&D, design development and design scale up, to ensure that the manufacturing and commercialization of the products comply with EU regulations.