Are you preparing for EU-MDR?
The medical device industry is presently facing massive reform like MDR (Medical device regulation) something never seen before. The massive changes will force many companies to do global reassessment and implement necessary changes to remain compliant. Even CE mark under MDD will also undergo major changes and your existing product will need re-certification. Clinical data and labelling also will need updating. UDI (Unique Device Identification) system is being established to track devices throughout the economic operator supply-chain. Serious incident reporting time has changed from 30 days to 15 days and all data will be centralised so everyone can access it. So, manufacturer has to be vigilant and quality of the product must be robust enough to take care of safety aspect. Conduct an audit Hopefully at this stage, your organization has already run a comprehensive audit to spot compliance gaps and confirm what changes need to be done Make internal product information systems compatible with EUDAMED One of the core necessities facing medical device manufactures that hope to continue doing business in European markets is submitting device information to the European EUDAMED. That data includes distinctive device identification numbers, product information and clinical proof information. The EUDAMED can perform as a centralized repository of data from that numerous entities, like Notified Bodies, regulatory bodies will all access and look at medical device information. Work with an experienced implementation partner for MDR preparation. Apart from changes described above, there is going to be major changes in quality system too which needs a focus. Risk assessment and post market assessment will need more focus as impact on business is very high. It is highly recommended to look for a good service provider to support you in this transition. Top Management should not get worried about the changes which need in-depth understanding and execution in right and timely manner. Use your resources for better implementation based on advice and guidance you receive from hired experts who have already prepared lot of groundwork on how to do this.