Update of the EMA Q&A document on Combination Products
Combination products (the combination of a medicinal product and a medical device) are increasingly "on the rise". However, the regulation governing these combination products is very complex. For the EU area, the EMA Q&A document Questions & Answers for applicants, marketing authorization holders of medicinal products and notified bodies with respect to the implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746) provides assistance in this regard. The document was revised at the end of 2023. What is new?
Notified Body Survey on Certificates and Applications under the Medical Devices/IVD Regulation
The results of a survey of 39 Notified Bodies were published by the EU Commission at the end of 2023. It concerns certifications and applications under the Medical Device/IVD Regulations (MDR/IVDR). What are the results?
MDCG Guidance on the Responsible Person according to Article 15 MDR Updated
With the implementation of the Medical Device Regulation (MDR), a "responsible person" according to Article 15 MDR also became mandatory. Minimum requirements for this "person responsible for regulatory compliance" are specified in this article. Further information can be found in the guideline "MDCG 2019-7", which has now been revised. What are the changes?
FDA Publishes Lists of Planned Medical Device Guidances for Fiscal Year 2024
In October 2023, the Center for Devices and Radiological Health (CDRH) published a list of new guidance documents planned for fiscal year 2024 (1 October 2023 - 30 September 2024), as well as older guidance documents that will be reviewed for current relevance. What new guidelines are coming?
In the US the Center for Devices and Radiological Health is responsible for medical devices. The CDRH is also increasingly involved in harmonisation efforts. What is planned?
The FDA Center for Devices and Radiological Health (CDRH), which is also responsible for medical devices, has published tips on how to comment on guidance documents issued by the CDRH. What does it say?
Changes in the Notified Body Postion Paper on Hybrid Audits
End of January 2023 you could already read about a 3.5 page position paper from Notified Bodies regarding their perspective on hybrid audits of medical device and IVD manufacturers. The position paper has now been updated.
How to create a Notified-Body-compliant Technical Documentation
One of the most important documents in the context of medical device regulation is the technical documentation. Recently updated to version 2, a helpful position paper from Team Notified Body serves as a best practice guide on this topic. Read more here.
How to create a Notified Body compliant Technical Documentation?
One of the most important documents in the context of medical device regulation is the technical documentation. Updated as version 2, a helpful position paper from the Team Notified Body provides assistance in this regard as a best practice guide.
Dealing with Artificial Intelligence in the Context of the further Development of Software in Medical Devices
The topic of artificial intelligence/machine learning (AI/ML) is currently all around. The FDA has also taken up AI/ML and published various draft guidance documents. A current draft is aimed at manufacturers of medical devices that contain software.
FDA publishes Lists of planned Medical Device Guidances 2023
In October 2022, the Center for Devices and Radiological Health (CDRH) published a list of new guidances planned for fiscal year 2023 (1 October 2022 - 30 September 2023), as well as older guidances to be reviewed for topicality. What is planned?
The FDA released the final guidance on Comparability Protocols for postapproval CMC changes. The revised guidance follows the draft version issued in April 2016.