MedTech Academy
The CLIN-r+ MedTech Academy is a complimentary service, here you will find all things Medical Device and IVD updated at your leisure. At CLIN-r+ we believe in sharing knowledge so that manufacturers and innovators can bring great technology to healthcare. As the guidance documents continue to evolve, we offer you the information you need for successful MDR/IVDR transition. If you’d like the MedTech Academy information sent directly to your inbox, make sure you join our mailing list.
This guidance introduces significant updates and expectations for chemical analysis in the context of biocompatibility evaluations, aligning with global regulatory trends and emphasizing the importance...
The International Organization for Standardization (ISO) has announced the upcoming release of the revised ISO 10993-1: Biological Evaluation of Medical Devices — Part 1: Evaluation...
The ISO 18562 series of standards, which governs the biocompatibility evaluation of breathing gas pathways in healthcare applications, has undergone a significant revision in its...
On 21 May 2024, the MHRA published a Statement of policy intent: international recognition of medical devices update. This exciting development means that MHRA will...
Clinical investigations of medical devices - guidance for manufacturers from the MHRA, covers everything from the choice to conduct a clinical trial to the approval...
Medical device safety and performance can be demonstrated via clinical investigations. The Medical Device Coordination Group amended MDCG 2021-6 clinical investigation recommendations in December 2023....
Before CE registration, medical device classification is crucial. Classification affects the device's regulatory requirements, approval route, and expenditures. Manufacturers are responsible for the correct classification...
Conformity routes under the clinical data needs for the EU MDR are not well understood and can lead to unnecessary costs due to investment into...
Do manufacturers need to conduct investigations or follow an exemption route? CLIN-r+ explores the exceptions as outlined by MDCG 2023 and MDCG 2020-6....
What documents and resources are needed for performance evaluation requirements under IVDR? What is involved in the performance evaluation process for IVDs under the IVDR?...
What are Orphan Medical Devices? How are they regulated? How does EU MDR impact orphan medical devices? We explain all…...
What are common nonconformities identified under the EU MDR? What does a Notified Body want from your Technical Documentation? What can mitigate risks and ensure...
