We want to hear from you!
Medical implants for human applications are subject to high legal requirements to ensure safety and performance. As of May 26, 2021, the new European Medical Device Regulation (EU)2017/7458 MDR) ,  also applies to implants. This article outlines the regulatory requirements for medical implants in Europe as well as the connected procedure.
The BIOMATDB project develops a biomaterials database and marketplace. In doing so, we place particular importance on tailoring these solutions to the needs and requirements of their potential users. Therefore, we are conducting surveys with stakeholder groups that will benefit from the advantages of a database and marketplace in the future. The results from these surveys will be evaluated and taken into account for the development of the biomaterials database and marketplace. More information about the BIOMATDB solutions can be found in the description of our project objectives.
If you belong to one of the following groups, we would invite you to share your inputs with us:
- Researchers in the field of biomaterials or related disciplines
- Suppliers of biomaterials or related products
- Enablers like biomaterials soctieties or networks
- Demanders like hospitals, clinicians and purchasing organisations
- Investors & Policy makers in the field of biomaterials or related products
You can find the surveys here:
Investors & Policy makers: https://ec.europa.eu/eusurvey/runner/BIOMATDBSurvey22-Investors-Policy
We are looking forward to hearing your opinion!
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 Medical Device Coordination Group, MDCG 2019-7 Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a ‘person responsible for regulatory compliance’ (PRRC). 2019. Available at: https://ec.europa.eu/docsroom/documents/36166, accessed 05 Oct. 2022, accessed on 05.10.2022.
 European Commission, ed, “The ‘Blue Guide’ on the implementation of EU products rules 2016.” July 26, 2016. Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/ PDF/?uri=CELEX:52016XC0726(02)&from=BG, accessed on 05 Oct. 2022.
 Global Harmonization Task Force, Role of standards in the assessment of medical devices.
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 S. Hallscheidt, N. Adomeit, T. Manske, and J. U. Hopf, “1×1 der Normung – Ein praxis-orientierterLeitfaden für KMU.” May 2019. accessed Sep 19, 2019. Available at: https://www.din.de/blob/64110/b5d8d57f3b7e6866233201bf45aad388/1×1-data.pdf, accessed on 05 Oct. 2022.