As May 2022 approaches, the need for guidance on the In Vitro Diagnostics Regulation (IVDR) is growing. Regarding the topic of companion diagnostics, the EMA published a draft document at the end of last year about the consultation procedure between the EMA and a Notified Body.
FDA Audit Policy for Medical Devices: a Comprehensive Document
In the field of medical devices, the Medical Device Single Audit Program (MDSA) is accepted and even mandatory in some countries. Now, the FDA has published a very comprehensive policy on this audit approach consisting of 215 pages.
The FDA has published a draft Guidance for Industry with the title "Selected Update for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices". What will come?
Final EMA Guideline: Quality Requirements for Combination Products
Following a draft version, the EMA has now published the final guideline, which describes what documentation is required on the subject of quality for combination products in order to gain and/or maintain a marketing authorization. The guideline consists of 22 pages with 10 chapters.
FDA Inspection Compliance Program for Combination Products
Combination products are products that are subject to different sets of regulations. Such products may, for example, consist of a drug and a medical device, or a biological component may be added. Because of the different product components, special monitoring procedures are required.
EMA publishes updated Question and Answer Document on Combination Products
With the EU regulations 2017/745 and 2017/746 on medical devices (MDR) and in vitro diagnostics (IVDR) coming into force on May 21, 2021, new requirements have been/will be imposed on combination products with regard to their medical device component. There is an updated question and answer document (Q&A) from the European Medicines Agency on current issues.
EUDAMED - Current Status of the Database for Medical Devices
The European Commission published Questions & Answers on 26 May 2021, the day of application of Regulation 2017/745 for medical devices. The Questions & Answers are related to the requirements and tools for the safety of medical devices, including EUDAMED.
EU-Switzerland: MRA for Medical Devices no longer valid
Due to the new EU Regulation on Medical Devices (2017/745) and failed negotiations between Switzerland and the EU, the corresponding Mutual Recognition Agreement (MRA) will become obsolete. This has far-reaching consequences.
The US FDA recently issued a draft guidance to help manufacturers implement ICH Q12 by explaining how to submit ECs. In addition, the agency provides general guidance about the elements that are considered ECs for the device constituent part of combination products.
Questions and Answers Document on Audit Alternatives of Notified Bodies
In a previous News you could read about audit alternatives of Notified Bodies in Covid-19 times. The guideline was based on a document of the Medical Device Coordination Group (MDCG). This guideline has now been supplemented by a question and answer document.