We offer support in obtaining the required documents for the marketing of new products prior to the application of the MDR, contact Notified Bodies and Competent Authorities for conformity assessment and notification procedures, and advising on the interpretation of the requirements of the MDR Regulation.
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.