Question 1

When will the IVDR regulation apply?

Accepted Answer

The IVDR Regulation will apply from 26 May 2022. The Regulation will replace Directive 98/79/EC.

Question 2

IVDR implementation

Accepted Answer

Defining a strategy for action, the required conformity assessment procedures and methods for the implementation of in vitro diagnostic medical devices is crucial to ensure compliance with the IVDR efficiently and at the lowest possible cost.

Question 3

IVDR consulting

Accepted Answer

We offer support in obtaining the required documents for the implementation of in vitro diagnostic medical devices prior to starting to apply the IVDR, contacting notified bodies and competent authorities with regard to conformity assessment procedures and advising on IVDR requirements.

Question 4

When will the IVDR regulation apply?

Accepted Answer

The MDR Regulation will apply from 26 May 2022. The Regulation will replace the current Directive 98/79/EC.

Question 5

What are the differences between IVDD and IVDR?

Accepted Answer

The IVDR Regulation introduces a new position in the structures of medical companies, the Person Responsible for Regulatory Compliance (PRRC). Regarding to current Directive, the classification of some devices also changes, therefore it is worthwhile to analyse the intended use of the device in order to determine the correct classification. There are changes to the conformity assessment procedures, rules for performance evaluation, post-market surveillance and registration of economic operators and in vitro diagnostic medical devices.

Question 6

How can we help?

Accepted Answer

We can help you in:

obtaining the required documents to place new products on the market before the IVDR is applied,

contacting notified bodies and competent authorities,

defining conformity assessment procedures.

Our experts will help your company to implement the IVDR quickly and effectively.