As you might already know, medical devices need to be approved according to the MDR after May 25, 2020. This regulatory amendment will bring significant changes in the approval of medical products, which will lead to additional efforts and the need of further experts. In general, medical products need to be classified again according to the new rules. One major amendement is that all medical products consisting of materials or a combination of materials are now classified in a risk class higher than I (rule 21). Among others are nasal sprays, oral sprays and lonzenges with localised impact which are now classified into risk class IIa, instead of I. This will have tremendous consequences on the scope of the regulatory process.
ADDITIONAL TASKS TO BE FULFILLED DUE TO THE MDR
- setting up a quality management system according ISO 13485 due to the higher classification of the medical product
- holding all relevant QM documents ready to be inspected by the notified body
- establishment of a post-market surveillance system
- preparation of more detailed clinical evaluations
- conctact with a suitable notified body to submit technical files
- designation of a qualified person for the production of the medical devices
- considering more detailed requirements for the technical documentation
- preparation for audits and continous readiness for unannounced audits
- implementation of the UDI
REACT NOW, OTHERWISE YOUR COMPANY WILL GET INTO TROUBLE
The facilities, processes and files should be revised as soon as possible and timely actions need to be set for a smooth transition from the requirements of the MDD to those of the MDR. In case you don’t make arrangements now, you might miss the deadline for the transition and then the sale of the medical devices certified according to the MDD is not possible anymore. This will have a huge impact on the profitability of the company!
ARCORO HELPS YOU
arcoro offers you an appropraite solution for the fast and efficient recruitment of qualified consultants. The experts will help you to solve the additional tasks which need to be implemented for the successful regulatory approval of your medical devices according to the MDR.
You can directly contact me:
+49 89 26 20 994-11