Counting down to Medical Device Regulation (MDR)

1. Comprehensive lifecycle approach 

MDD focused primarily on pre-market conformity assessment, whereas MDR introduces a more comprehensive lifecycle approach. It emphasizes post-market surveillance, clinical evaluations, and vigilance, ensuring ongoing compliance throughout the device's lifespan. 

2. Increased Scrutiny and Stringency: 

MDR raises the bar by demanding more stringent clinical evidence for high-risk devices. It sets higher standards for conformity assessment procedures and emphasizes the need for continuous assessment, implying greater scrutiny of device performance and safety. 

3. Unique Device Identification (UDI): 

One of the standout features of MDR is the requirement for a UDI system. It mandates that each medical device carries a unique identifier, enhancing traceability, and facilitating quicker recalls, if necessary, thereby significantly boosting patient safety. 

4. Heightened Transparency and Data Sharing: 

MDR advocates for heightened transparency by creating a European database on medical devices (EUDAMED). This facilitates information exchange, enhances market surveillance, and ensures easier access to data for both regulatory authorities and the public. 

5. Stricter Post-Market Surveillance: 

MDR places greater emphasis on post-market surveillance and vigilance, necessitating continuous monitoring of device performance, adverse events reporting, and corrective actions. This approach aims to swiftly identify and rectify any potential safety concerns. 

1. Assessing Compliance: 
The journey begins with a comprehensive assessment of your current compliance status. Conduct a meticulous gap analysis to identify areas that need attention and generate a task list for updating procedures and documentation. 

2. Clinical Data Coverage for Marketing Claims: 
Ensure that your marketing claims are substantiated by robust clinical data. With MDR placing a greater emphasis on evidence, having comprehensive clinical data is essential for a seamless transition. 

3. Portfolio Assessment: 
Conduct a thorough portfolio assessment to determine which products are in scope for transition. Strategic investment in key products will pave the way for a smoother adaptation to MDR requirements. 

4. Notified Body Certification: 
Verify the readiness of your Notified Body to provide MDR certification. Timeliness is crucial, so ensure that your Notified Body is equipped to support the full applicable scope of your devices within the required period. 

5. Classification Review: 
Evaluate whether the classification of your devices is subject to change. Manufacturers need to determine if new conformity assessment routes are applicable to their product portfolio, anticipating shifts in the regulatory landscape. 

6. Technical Documentation: 
Ensure that you have full technical documentation for all devices in your market. This includes post-market clinical data, a crucial component of the ongoing assessment process under MDR. 

7. IT Process Readiness: 
MDR provides an opportunity to evaluate and upgrade your IT processes. Ensure your systems are ready to handle the new requirements. Pay particular attention to UDI (Unique Device Identification) processes and keep abreast of developments and requirements for the European Database on Medical Devices (EUDAMED). 

1. Stricter Control for High-Risk Devices: 
MDR introduces a groundbreaking pre-market scrutiny mechanism for high-risk devices, involving a consortium of EU-level experts. This stringent control mechanism ensures an elevated level of scrutiny during the pre-market phase, fostering increased safety and reliability for these critical devices. 

2. Inclusion of Aesthetic Devices: 
MDR extends its scope to include certain aesthetic devices that share characteristics and risk profiles with analogous medical devices. This inclusion ensures that all devices, regardless of their intended use, are subject to the same rigorous regulatory standards. 

3. Transparency and Traceability Enhancements: 
MDR takes a giant leap toward transparency by establishing a comprehensive EU (European Union) database on medical devices. Additionally, the introduction of a device traceability system based on Unique Device Identification (UDI) further enhances transparency throughout the supply chain, bolstering traceability and accountability. 

4. Patient-Centric Approach: Implant Cards: 
In a move towards greater patient empowerment, MDR introduces the concept of an "implant card." This card contains essential information about implanted medical devices, providing patients with vital details, and fostering a patient-centric approach to healthcare. 

5. Reinforced Rules on Clinical Evidence: 
MDR strengthens the rules on clinical evidence, introducing an EU-wide coordinated procedure for the authorization of multi-center clinical investigations. This coordinated approach ensures consistency and reliability in gathering clinical data for regulatory assessments. 

6. Post-Market Surveillance Reinforcement: 
MDR places a stronger emphasis on post-market surveillance requirements for manufacturers. The reinforced surveillance mechanisms ensure timely identification and response to any issues that may arise after a device enters the market, prioritizing patient safety. 

7. Enhanced Coordination Mechanisms: 
MDR fosters improved coordination between EU countries in the realms of vigilance and market surveillance. This collaborative approach ensures a unified response to potential issues, facilitating quicker and more effective interventions. 

1. Transition Period Extension: 
For medical devices covered by certificates or declarations of conformity issued under the MDD before 26 May 2021, an extension to the transition period applies. This extension spans from 26 May 2024 to 31 December 2027 for higher-risk devices and until 31 December 2028 for medium and lower-risk devices. 

2. Conditions for Extension: 
It's crucial to note that this extension comes with certain conditions. Only devices deemed safe, and for which manufacturers have already taken substantive steps –as applying to a Notified Body to transition to the rules outlined in the Medical Devices Regulation, will benefit from the additional time. 

3. Class III Implantable Custom-Made Devices: 
The proposal also introduces a transition period until 26 May 2026 specifically for Class III implantable custom-made devices. This extension affords manufacturers more time to obtain certification from a notified body. Again, this extension is subject to the application of the manufacturer for MDR conformity assessment of devices of this type before 26 May 2024 as well as to meeting the conditions at point 2 above. 

1. Compliance for Existing Certified MDD Products: 
According to MDR (Medical Devices Regulation), manufacturers are mandated to comply with the regulation when introducing new medical devices to the market. Furthermore, all currently approved devices must undergo recertification in alignment with the new MDR requirements.  

2. Implications of not updating to MDR: 
If existing MDD-certified products are not updated to meet the MDR requirements within the specified periods outlined in MDR Article 120(2), manufacturers are obligated to remove these products from the market once their MDD certificates expire. 

3. Sell-Off Provision: 
The "sell-off" provision, initially aimed at limiting the time for compliant devices under Directives already on the market, has undergone changes in the amended MDR, specifically in Article 120(4). The deadline for further availability of these devices, previously governed by existing Directives, has been removed. Consequently, medical devices placed on the market in accordance with the MDD before May 26, 2021, or during the transitional period outlined in Article 120 MDR (extending until December 31, 2027, or December 31, 2028, as applicable), may continue to be marketed or used indefinitely, with no time restrictions, while respecting the device's potential shelf-life or expiration date. 

3. Alternative Compliance Route - MDR Article 97: 
For MDD "legacy devices" transitioning to MDR, and for devices placed on the market before 26 May 2021, an alternative compliance route might be available under MDR Article 97. Detailed information on this alternative can be found in the MDCG 2022-18 document: Link to MDCG 2022-18. 

1. Navigating Editions: Does 'State of the Art' Always Mean the Most Recent Standard Version? 

Understanding which edition of the standard to apply under the MDR is a common concern. The MDR emphasizes the principle of "state of the art," implying that manufacturers should utilize the most recent version of the standard available. However, it's essential to note that this doesn't mean a blanket requirement to always use the latest edition. 

The term 'state of the art' is contextual and considers the latest technological and scientific developments relevant to the specific medical device. It encourages manufacturers to adopt the most recent version of the standard, but it allows for flexibility. If a specific edition remains relevant and aligns with the technological and scientific knowledge at the time, its application can be justified. This decision, however, should be thoroughly documented, demonstrating a deliberate choice based on the device's characteristics and intended use. 

2. Harmonization of Base and Particular Standards: Can I Apply 'State of the Art' Versions Harmonized with Previous Standards? 

Yes, the MDR acknowledges the harmonization of base standards and Particular Standards with previous versions. Manufacturers can apply the 'state of the art' version of the base standard and align it with Particular Standards that are harmonized with the previous version. This approach allows for a more seamless transition, recognizing that some standards evolve at a different pace. 

However, it's crucial to exercise due diligence in ensuring that the chosen harmonized standards still meet the essential requirements of the MDR. Regularly review and update your conformity assessment strategy to align with any changes in harmonization status or the introduction of newer versions.