Posts tagged with "Guidance"

06. January 2020
The European Commission published the first EU Guidance on Cybersecurity: MDCG 2019-06. This document addresses the aspects: Basic Cybersecurity Concepts Secure Design and Manufacture Documentation and Instructions for use Post-Market Surveillance and Vigilance The last chapter compares the current state of the existing guidances under the headline: Other Legislation and guidance: EU and International For the practical approach to the question what are the known hazards on cybersecurity the...

18. December 2019
The guidance MDCG 2019-15 includes a comprehensive overview of the manufacturers‘ obligations for all Class I products. It also gives some further clarification concerning the "Authorized Representative": A manufacturer with a registered place of business outside the Union will designate a sole authorised representative, at least per each generic device group, according to a written mandate. At the same time it includes further specifications of the manufacturers' obligations: The...

07. June 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. May 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...

20. November 2018
The EU Commission previously published the factsheet for EU based medical device Manufacturers that is now amended by two further factsheets for Non EU Authorities and economic operators.

01. November 2018
Update of the Borderline Products Guidance issued by the EU-Commission introducing 5 new borderline products.

27. March 2018
Guidance for the update of the "Betreiberverordnung"

29. December 2017
Health Canada updates the guidance "Application for new medical devices"

02. February 2017
A new guidance on clinical evaluation is now available...