As old manufacturer of medical device you were naturally MDD compliant and to remain in business you will have to become MDR compliant too.
As Medical device business you also must have accounted the compliance cost to your product to assess the product cost and added your profitability to arrive at Product cost. The same exercise is now necessary as compliance cost will increase, in some cases substantially if your product class changes from say II to III. It is also difficult to explain to customer about increase in compliance cost may be some doctor may understand but overall, its difficult task. In view of this, whole exercise needs to be done with minimum expense and least possible time, so your approach must be thorough professional.

Taking clue from part I blog let us ask some questions to ourselves and get answer ready and actions if needed. Study of guidance document MEDDEV 2.7.1 is must.

1. Clinical evaluation now applies to all classes of product and this exercise is very big specifically for class III and product which will transit from Class II to Class III as per MDR. See our Blog on Clinical evaluation which describes in detail what is required so in terms of resource and cost, this is on top attention. This will no longer be just one time activity but life cycle continuous activity. Summary of safety and clinical performance (Article 32) stressing the need for Quality system on risk management. (Article 54 for class III and class IIb) General requirement of clinical investigation for conformity assessment (Article 63)

2. UDI system implementation is another big task and time consuming. Your resources must not only be enough but must also be adequately trained. (Article 27) This requires full system establishment each device will have unique device identification. The system should be electronic database so it can be made available to all required as mentioned in MDR.

3. Registration of device (Article 29)

4. Registration of Economic operator through electronic system. (Article 30) Single registration number (SRN) and procedure to communicate with commission or member state for SRN.
5. Registration of Manufacturer’s authorized representative and importers. (Article31)

6. Classification of device. Very essential and important documentation is needed here. This need to be maintained for each class of devices you are dealing with and how you arrived at specific classification using guideline points as per MDR. As mentioned in Part I classification of your existing device may change so entire technical documentation associated with that device. (Article 51)

7. Conformity assessment procedure (Article 52) and involvement of notified bodies (Article 53)

8. Eu Declaration of conformity (Article 19) The requirements specified in MDR is fulfilled for that specific device and technical documentation in each language is needed where this device is going to be marketed.

9. Requirement for a person of regulatory compliance (Article 15) and change of authorized representative (Article12) It is now mandatory to have a person on role with exclusive responsibility of regulatory compliance so naturally he will be completely knowledgeable person so additional resource and expense. Same is true for change of authorized representative where lots of documentation and transition period are defined.

10. Implant card and information to be supplied to patient. (Article 18) This is an additional compliance work.

11. post-market surveillance its plan and system (Article 84 and 83)

12. New reporting requirement of Periodic safety (Article 86), serious incident and field corrective action (Article 87), Trend data (Article 88). Analysis of serious incidents and field corrective actions (Article 89), Vigilance reporting is now within maximum 15 days.

13. Various annexures describing technical documentation need, a) conformity assessment based on QMS and assessment of technical documentation (Annex IX), b) conformity assessment based on type of examination (Annex X), c) conformity assessment based on verification (Annex XI), d) Clinical evaluation based on Post Market clinical follow up (PMCF) (Annex XIV), e) Clinical Investigation (Annex XV)

You have now many points to read and assess your system. Please ask one question to your team whether they understand all points well from MDR and guidance documents? There should not be any ambiguity or doubt or otherwise you will have non-compliance during audit. Your quality Management system must come under compliance. All actions decided during gap assessment must be complete. Review of that is needed before proceeding to next item. Attention now should be on Notified body. Check with team for readiness.

Please note that QMS is common for your organization but review your product portfolio and see whether you are ready for broader EU market? It is not just your organization, but your supplier and contractor also may pose challenge and their readiness. If not, you have mammoth task for changing them and bringing new.

Base on product portfolio make judge your readiness for certain product and wait for other till you are fully compliant. Gap assessment must also consider change of contractor if needed and impact of signed agreement. Micro and Macro management also need to be managed well to avoid unnecessary complexity and save time.

Do not forget training all people involved must undergo training to know new requirement to the extent they are supposed to know related to their responsibility. Knowing does not mean, just knowing the requirement but interpreting the same for your own product. This would need an external support where expert can pitch in.

Senior Managers expects that regulatory person knows well and can do what is needed. This is the area where what is planned and executed my not match an experienced third-party consultant like Iziel can identify the Gap which internal resource may not be able to do.

Where third party experts like Iziel can add value. Planning of entire Transition project and monitoring the same. Execution timings are essential for project timeline so expert consultant will prioritize activities such as longest time activity to start first where possible. Gap assessment identity and plan execution and Product portfolio understanding and rationalizing. Training

The complex project can be made easier by arming entire team with required knowledge of MDR articles and chapters along with required tools to apply.

Changes in clinical data will be another challenge as companies need to demonstrate clinical data with clinical claim and each intended use. Notified body will also be more vigilant on such aspects and will come prepared.