Eu MDR implementation guide
If you are in medical device business and exporting to European union then MDD term must be familiar but now if you want to continue your export to European union then learn about what MDR states The European medical device industry will undertakeimportant changes as a result of the new medical device regulation which was signed on May 26th, 2017. As the name says, is it a regulation and no longer a directive like MDD and all medical device companies that sell medical products in European union havetofollow to this new regulation. Businesses that do not obey this regulation were no longer be permissible to sell their medical products in the European Union after May 26th, 2020 as per original schedule however an extension has been granted due to present corona pandemic and new date is now May 26 th 2021. All medical device companies therefore have this new date to comply. This rule is applicable to all depending on your role as economic operator (manufacturer, importer, authorized representative, distributor) the impact is different for all but it is significant and meaningful.
EU MDR IMPLEMENTATION Below you will find a step-by-step implementation guide with regards to the new medical device regulation (MDR EU2017/745). The guide is simple to recognise and will permit you to save time and money when implementing the new regulation.
1. DEVICE CLASSIFICATION ALL DEVICES YOU SELL NEED TO BE RECLASSIFIED AS PER NEW GUIDELINE AND IMPACT HAS TO BE ASSESSED. (SUPPOSE YOUR CLASS II DEVICE BECOMES CLASS III AS PER NEW GUIDELINE THEN IMPACT ON COMPLIANCE IS VERY SIGNIFICANT) 2. ECONOMIC OPERATORS YOUR ROLE AS STATED ABOVE NEED TO BE ASSESSED SEPARATELY, 3. Notified Body: Ensure that Notified body you select must be under MDR approved list. 4. GAP ASSESSMENT STUDY COMPLETE RULE AND PREPARE GAP LIST. 5. IMPLEMENTATION (a) Safety and performance checklist (b) Technical File (c) Risk management according to ISO 14971 (d) UDI System (e) Post-Market Surveillance (PMS) (f) Post-Market Clinical Follow-Up (PMCF) (g) Clinical Evaluation (h) Labelling (i) EUDAMED (European database on medical devices) (j) Common Specifications 6. VERIFICATION / IMPROVEMENT 7. FINAL CHECKLIST
Above are just checklist headings and each must be studied in detail. It is always recommended to have services of professionals like Iziel healthcare for gap assessment and preparing QMS system as quite a few topics need competent advice otherwise last-minute delay can cause significant business delay and financial loss and customer reputation impact.