Artikel mit dem Tag "medical"



07. Juni 2019
The latest MDCG Guidance includes "Questions and Answers, relating to Notified Bodies" for the application of the MDR. Although the focus as identified in the title are the Notified Bodies some interesting information for the manufacturers can be found as well. Just to name two topics: Auditing of subcontractors OBL situation under the MDR

23. Mai 2019
The EU Commission posted a new version of the Borderline Guidance with revision 1.22 New Amendments in the current version are: Automated external defibrillator storage units If it is intended to be used with an individual AED to store it in the environmental conditions It should be considered an accessory Lubricants intended for alleviation of vaginal dryness According to Rule 5, these lubricants should be classified in class IIa Medication decision support software The software is intended to...

15. Mai 2019
The Indian regulatory body: Drugs Controller General (India) Directorate General of Health Services FDA Bhawan, Kotla Road, New Delhi. published on the CDSCO Website a new classification list today: link to the list

01. April 2019
The GMDN Agency now opened a "Basic" account that allows search in The GMDN database without any charges. Only a user registration is necessary to create the online access. Further information is available on the GMDN agency website. However, you may search by product NAME but it will NOT show you the CODE unless you buy it! Searching for the CODE will show you the NAME and the detailed information. The previous paid accounts will remain available for the previous fees including extra services...

15. Januar 2019
The European Commission published new Templates for Manufacturers to report Serious Incidents under the MDR/IVDR and Incidents under the MDD/AIMDD/IVDDD. This does not only include an integration of the new legislation but it also strengthens the internal harmonized communication concerning incidents by also using the global harmonized categories published by the IMDRF. As a consequence the template now includes 12 pages.... The version 7.1 of the Template now also integrates the new aspects...

21. August 2018
Health Canada is introducing a new structure for the submission of device license information of class III and IV products following the INDRF Guidance on nIVD(MA)ToC.

22. Januar 2018
After the Brexit manufacturers need to find a new Authorized representative and a new Notified Body if they use these service Providers in the UK.

07. Dezember 2017
The Borderline Working group chaired by the EU Commission published the updated Version 1.18 of the "MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES". The document is intended to act as a guidance for the interpretation of the MDD and IVD. The new paragraphs introduced by the update are identified by the pictogram "New" and include the products: Products intended to reduce the effect of alcohol Radiation shields D-mannose for the prevention of...

26. November 2017
Switzerland paves the road for the implementation of the MDR requirements into national legislation.

23. November 2017
Three days prior to the application date for the future Notified Bodies the EU commission published the final version of the first Implementing Act „Codes for Designating Notified Bodies“ under the MDR. Although it is still missing the official document registration number it was used for the first applications send by the Notified Bodies to their national accreditation Bodies. The previous draft version of the Implementing act is now obsolete. As mentioned for the draft this document may...

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