IVDR - History
The previous regulation - the EU Directive 98/79 / EC - on in vitro diagnostics has been replaced by the EU Regulation 2017/746 (IVDR) passed by the European Council on May 7th, 2017. The new EU regulation came into force on May 26, 2017. It creates massive changes for IVD manufacturers across the EU market.
There is a transition period for products that have already been approved in order to meet the requirements in all respects.
However, anyone who believed that there would be delays and further delays due to pending or pending legal acts - would soon be taught otherwise. Despite all resistance, the transition periods have not yet been extended!
ESSENTIAL CHANGES
IVDR (EU Regulation 2017/746)
Greater scope
Now, among other things also includes high-risk products that are manufactured and used in a facility. It also includes:
- IVD for diagnostic purposes (including internet-based purposes),
- genetic studies,
- Predisposition tests for patients for disease risks and treatment effects.
Classification system
The IVDs are assigned to new risk classes A to D. The rules represent a system based on the corresponding risks. There are no product lists - only these classification rules. Products with the lowest risk are assigned to class A, the highest risk class is D.
According to the classification of the product in the respective class, there are different requirements when implementing the regulation.
Notified bodies
The participation of the notified bodies will be required for more products than before. In addition, stricter requirements apply to the designation and monitoring of the notified bodies. This will result in fewer jobs. In certain risk classes, it is also necessary to involve the responsible authorities and reference laboratories. The duration of the conformity assessment procedure depends on the respective risk class and can therefore also be significantly extended.
Unique product number
A system for special product identifiers (Unique Device Identification, or UDI for short) is introduced. This system is expected to be the same as the UDI system of the FDA (USA). It is open whether the UDI databases can be synchronized and a global UDI is used. This allows products to be traced and recalls are possible. Manufacturers must implement this, apply for the UDI of their products and label them accordingly.
Strict specifications for technical documentation
The TD will be more extensive and detailed in the future. Manufacturers also need to continuously assess potential security risks by collecting and storing clinical data. Basically, studies and evidence are required that the safety and performance of the product are appropriate for the risk class.
Determination of a responsible person
Manufacturers must designate at least one person who is responsible for compliance with the above. Regulation in your company / organizational unit. Proof must be furnished that this person is sufficiently qualified for this.
However, these listed points represent only a small - not exhaustive - compilation of what we consider to be essential innovations.
In any case, we recommend that you check the IVDR with regard to a specific product for the respective requirements.
WHAT CAN YOU DO AS A SUBJECT?
As a manufacturer of in vitro diagnostics, you are fundamentally faced with a complex and time-consuming process. You cannot avoid this process, as there is ultimately no inventory protection for products on the market.
We recommend you as a manufacturer of in vitro diagnostics:
- do not let unnecessary time pass since the procedure will in any case be complex. Further delays can also be expected due to the reduction in the number of notified bodies.
- Think about a strategy for implementing the IVDR in your company. Consider time-consuming contacts with Notified Bodies and possibly other authorities.
- If you have any doubts about the classification of your products in the relevant IVDR risk class, contact the Notified Body in good time (or hire an external service provider) - assume that other companies will also have this problem.
- Make a decision whether you want to take over the entire process yourself and / or if you want to hire a (proven and potent) consultant.
OUR EXPERIENCE - YOUR ADVANTAGE
We can draw on the extensive experience of our employees in this field and related areas when it comes to the approval of your in vitro diagnostic products, individual questions about this procedure or services related to this.
In addition to our doctoral team, actively practicing doctors with their expertise from point-of-care testing, medicine, medical technology and medical informatics are available exclusively for our clients as consultants.
- Experience of more than 30 years in scientific and clinical work
- Your technical documentation is written by experienced employees with appropriate degrees (including a doctorate in the life sciences area).
- Based on our experience, we create your documents quickly, to a sufficient but not excessive extent, in a standard-compliant manner.
- We take on all related services in a highly qualified manner - we look after you until the successful completion.
For information
The full text of the regulation can be found on the EU public website. To the legal text
Possible services of QiP GmbH
Our team takes over for clients or supports them with the following services (exemplary):
- Contact with the Notified Body, coordination on the risk class
- Creation and updating of documents
- Independent performance reviews
- Market observations, market analyzes, PMS, PMPF, PSUR, safety reports
- Vigilance (trend reporting, reports and analyzes of serious incidents, safety corrective measures in the field)
- Collection of clinical data
- Master plans, overviews, evaluations
- Quality and safety reports
- Monitoring of improvement measures (action plan) acc. Corrective and preventive measures (CAPA procedure)
- Risk management (including risk analysis, risk assessment, risk control)
- Assistance with approval
- Technical Documentation
- Preparatory work for the preparation of clinical studies
- Checklists
In principle, we can accompany you in all points of the procedure. We would be happy to advise you free of charge and without obligation on a possible service package for your specific product / project.
Sometimes the first step is the easiest - but also the most important one: contact us