In vitro diagnostic medical devices - contents and implementation of the new European IVD regulation
The placing on the market, use and market surveillance of IVD products are regulated by law. In the future, the IVD Directive will be replaced by the IVD Regulation (IVDR - (EU) 2017/746), with an effective date of application on May 26, 2022.
The aim is to eliminate identified weaknesses, adapt the requirements to the now changed international rules, while ensuring a high level of product safety, health protection for patients and users, and supporting innovation. The new risk classification plays a central role in the IVDR. A big number of IVD products are classified in a higher risk class compared to the previous legal framework, which will require the involvement of a notified body in the conformity assessment procedure now. This one-day training will teach you about the new requirements involved with the IVDR that have to be implemented by medical device manufacturers - especially by manufacturers of in vitro diagnostic devices.
- In-vitro Diagnostics Regulation (IVDR)
- Updated transitional provisions and periods according to Regulation (EU) 2022/112
- Important definitions
- Obligations and innovations for economic operators
- Manufacturers, authorised representatives, importers and distributors
- New classification system for in vitro diagnostic medical devices
- Risk-based classification (class A, B, C and D)
- Conformity assessment procedure according to the In-vitro Diagnostics Regulation
- Role of the Notified Body
- Requirements for IVD products and their documentation
- Technical Documentation
- Clinical evidence, performance evaluation including analytical and clinical performance studies
- Traceability requirements (Unique Device Identification (UDI) and EUDAMED)
- Registration of economic operators and products in EUDAMED
- Post-market surveillance (PMS) after placing in the market / post-market performance follow-up (PMPF)
- Vigilance and market surveillance
- Outlook on national medical device legislation (MPDG & Co)
- Current guidance documents of the Medical Device Coordination Group (MDCG)
- In this seminar, we will familiarize you with the In-Vitro Diagnostic Regulation (IVDR).
- You will know the prescribed changes under the IVDR in respect to the classification of in vitro diagnostic medical devices.
- You will be well informed what conformity assessment procedures are applicable for the respective products.
You will know the requirements, e.g. in the area of documentation, that are placed on manufacturers of in-vitro diagnostics.
- Manufacturers of in-vitro diagnostic products and their employees in:
- R&D/ Production Department
- QM/ Regulatory Affairs
- Safety officers/ Person responsible for regulatory compliance (PRRC) acc. to Art. 15 (IVDR)
- EU authorised representative, importers and distributors
Upon completion of the modular further training (modules 1-4) In-vitro Diagnostics, you will acquire the recognized certificate “In-vitro Diagnostics Manager – TÜV”.
This requires successful participation in a final examination.
As a participant, you will receive a copy of the pocketbook In-Vitro Diagnostic Regulation (IVDR).
Certificate of attendance from TÜV SÜD Academy