MDR certification (Deloite)
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MDR certification (Deloite)

MDR certification (Deloite)

Step 1 - Understanding the EU MDR and IVDR As a medical device manufacturer, importer or distributor it will be critical to have a good understanding of the new regulations, the scope and full impact on the business. Many companies will have combination products and so both the changing pharmaceutical and medical devices regulations are relevant. Understanding the overlap and synergies with other applicable regulations and directives such as IVD, Clinical Trial Regulation (CTR) for human use, Falsified Medicines Act and Identification of Medicinal Product (IDMP) will be important. Step 2 - Medical device portfolio review and assessment A manufacturer's portfolio of products will need to be fully reviewed and assessed against the new regulations and future requirements. For example, under the new directive, products that are classified as accessories could now be covered under the definition of a medical device. With the new requirements there also may be product lines for which the classification status will change or the oversight by the Notified Bodies will be heightened without an increase in classification. It will be important to understand whether these products will need to be up-classified in the future and the associated impact. Some of the most critical areas that will require assessment include financial:

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