The list of European Union countries is growing. We offer help in obtaining the required approvals or CE marking for the marketing of new products in the European Union following the strict medical device regulations (MDR) imposed by the EU member states.
When will the MDR regulation apply?
The MDR Regulation will apply from 26 May 2021. The Regulation will replace the current EU Directives 93/42/EEC and 90/385/EC.
What are the differences between the MDD and MDR?
There are many differences between MDR and old MDD regulation. The MDR Regulation introduces a new position within the structures of medical companies, the Person Responsible for Regulatory Compliance (PRRC). In relation to the current Directive 93/42/EEC, the classification of certain devices also changes, so it is worthwhile to analyse the intended use of the medical device in order to determine the correct classification. Conformity assessment procedures, rules for clinical evaluation, post-market surveillance and registration of economic operators and medical devices are changing.
How can we help?
We offer help in obtaining the required documents to place new products on the market before the MDR begins, contacting Notified Bodies and Competent Authorities, identification of required conformity assessment procedures.
We work with your Quality and Regulatory organizations, either on site of remote, and perform a GAP Analysis to determine the current state of your Technical Files. We proceed by identifying steps that are needed to bring files under compliance with new MDR regulations.
We work side by side with your organizations to provide specific support as determined by management.
DD GlobalMedDev is ready to cooperate with your company regarding the new requirements of the Medical Device Regulation. We offer support in: obtaining the required documents for the implementation of new products before entering the MDR, preparing the MDR/IVDR implementation strategy, creating the necessary technical documentation in accordance with the new requirements, contact with notified bodies and competent authorities in the field of conformity assessment and notification procedures. Together, we will define the scope of activities and choose the best solution. If you would like to cooperate, please contact us.