Donawa Lifescience is specialised in in vitro diagnostic devices (IVDs) as well as ‘general’ medical devices, being able to offer regulatory and quality system support for both Europe and the US, covering CE marking, performance evaluations, and FDA submissions, including Pre-Subs, 510(k)s, de novos, and PMAs.
Donawa consultants have recent project experience in IVD product areas including:
- Tumour marker (cancer detection) tests
- Tests for immunological and infectious disease
- Detection of micro-organisms by chemical and immunological methods
- Coagulation tests
- Hematology tests
- Detection of micro-organisms by nucleic acid amplification methods
- Allergy tests
- Drug of abuse tests
- Therapeutic drug monitoring test
- Instrumentation (semi-automated to fully automated)
IVD manufacturers selling their products in Europe have, under the In Vitro Diagnostics Devices Directive (IVDD, 98/79/EC), been able to self-certify the majority of their devices for CE marking. However, under the In Vitro Diagnostics Regulation (IVDR, (EU) 2017/746), which entered into force in May 2017 and becomes mandatory in May 2024, around 80% of IVDs will need the involvement of a Notified Body before the CE mark can be applied. This includes ‘legacy devices’ that are already on the European market, but which will have to undergo new conformity assessments in accordance with the IVDR in order to remain on the market.
Manufacturers should therefore begin now to assess the impact of IVDR introduction on their products and plan accordingly to contract with a Notified Body and begin preparing the technical documentation required for CE marking. Many manufacturers will also need to install or update their quality systems to meet the MDR requirements.
Donawa provides a fully comprehensive service to help with IVD compliance in Europe and the US, from simply answering questions on the regulations to a significant involvement in quality system updates, technical documentation preparation, including performance evaluation, standards identification, General Safety and Performance Requirements’ compliance, risk analysis, and production documentation, together with post-market surveillance and reporting.