HEALTHCARE AND MEDICAL DEVICES E-SSENTIALS

The new IVDR – key information in a nutshell 

Something to watch out for! Since the new EU Regulation on in-vitro diagnostic medical devices (IVDR) came into effect in May 2017, the clock is ticking for all parties involved in the manufacturing of in-vitro diagnostics (IVD). For the first time, this group includes many institutions and companies to which the previous EU directive had not applied. All devices falling under the scope of the IVDR will require new or recertification within the next five years.

In connection with the new IVDR, there are three questions which you need to answer now:

1. Is my IVD medical device subject to new requirements?

In-vitro diagnostic medical devices which did not fall under the scope of the IVD Directive

Even if your medical device did not fall under the scope of the IVD Directive, it may need certification in the future. The scope of the IVDR (Chapter 1, Section 1, Art. 1) has been significantly extended compared to that of the former IVD Directive and will include, but not be limited to, the following medical devices in the future:

• High-risk in-vitro diagnostic medical devices manufactured and used within a single health institution
• IVD for diagnostic (including internet-based) purposes
• Genetic testing and other tests that provide information on a patient’s predisposition to a medical condition or on treatment response or reactions

In-vitro diagnostics already certified according to the IVD Directive

All products already certified must be recertified within a transition period of five years (i.e. by May 2022). In addition, under the new classification system of the IVDR, certification may be subject to significantly different requirements. The IVDR does not include a “grandfather” clause.

2. As a manufacturer of in-vitro medical devices, what do I have to do?

Appoint a person responsible for regulatory compliance

For the first time, the IVDR now requires manufacturers of in-vitro diagnostic medical devices to appoint at least one “person responsible for regulatory compliance” within their organization, who demonstrably possesses the requisite expertise.

Scheduling with foresight

Under the IVDR, more in-vitro diagnostic medical devices will require certification by Notified Bodies and, in addition, all in-vitro diagnostics already certified will require recertification within five years. Because of this, TÜV SÜD expects a large number of applications for certification, particularly towards the end of the transition period. Please take this into account in your scheduling, and contact us as early as possible to discuss open issues regarding the IVDR and your audit plan.

3. Who will be able to audit my IVD medical device in the future?

The new regulation also requires stricter scrutiny of the organizations that carry out audits, and defines a relatively strict designation procedure according to IVDR. As the largest EU Notified Body for medical devices, TÜV SÜD has already taken action and paved the way for its designation according to the IVDR.

Our specialists collaborate closely with authorities and are already prepared for the new regulatory framework. They are available now as your competent partners, and will be happy to answer any questions you may have and support you with preparing for the transition.