Posts tagged with "medical"

10. January 2020
With the announcement on "Therapeutic Goods Legislation Amendment" (2019 Measures No.1) the TGA informs about the intend to partially reform the existing legislation. What is addressed in this first package: Software (will be largely aligned with the EU MDR requirements) Personalised medical devices The amendment has an impact to the classification as well as to the Essential requirements. The details will be following early 2020.

07. January 2020
The updated GN-10: "Guidance on Medical Device Field Safety Corrective Action" is now published as Version 3.6.

06. January 2020
OSCAR is the Online Safety, Compliance Application and Registration System. It is intended to act as the online reporting tool for Field Safety Corrective Actions for cases when there is a field safety corrective action required for medical devices. The OSCAR system has officially launched on 6 January 2020 where Medical Device Dealers can begin submitting FSCA reports to HSA via the online platform. The users will need to apply for access by either: the company’s CorpPass, or the OSCAR ID.

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...

30. December 2019
The Indian CDSCO now appointed 8 Notified Body for the activities according to the Medical Devices Rules 2017: Intertek, India TÜV Rheinland, India TÜV Süd, India DNV, India BSI, India InterCert Saar, India Zenith Quality Assessors, India Publication: Notice 2019-12-30 The previous publication dated 2019-07-31 just listed 6 Notified bodies.

25. December 2019
The commission designated the German Notified Body MEDCERT ZERTIFIZIERUNGS- UND PRÜFUNGSGESELLSCHAFT FÜR DIE MEDIZIN GMBH as the ninth for the MDR. As of today the following Notified Bodies are designated for the MDR: BSI,UK - see News: "FIRST MDR Notified Body - BSI UK." TÜV Süd - see News: "SECOND Notified Body under the MDR - TÜV Süd Germany" DEKRA - see News: "THIRD Notified Body under the MDR - DEKRA Germany" IMQ - see News: "Notified Body number FOUR under the MDR - IMQ Italy" TÜV...

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...

16. December 2019
The long awaited second corrigendum (MDR COR 2) english Version of the COR 2 German Version of the COR 2 other languages Version of the COR 2 is now finally "deemed to be approved" by the EU-Parliament as there was no further request on voting on the ENVI Document during the meeting held on December 16th in Straßburg. It was handled as TOP 6 of that meeting and results with the following statement in the protocol: 6. Corrigenda (Rule 241) The ENVI and INTA Committees had forwarded the...

14. December 2019
Todays publication announces the eighth Notified Body being DEKRA B.V. Following the German headquarter that was already designated in August 2019 as Notified Body for medical devices and in October for IVDs the Dutch organisation is now able to provide its services around the world from the offices in Arnheim, The Netherlands and the subsidiaries in the USA. As of today the following Notified Bodies are designated for the MDR: BSI,UK - see News: "FIRST MDR Notified Body - BSI UK." TÜV Süd -...

12. December 2019
In the MDCG 2019-13 the EU Commission publishes further details on the sampling of the technical documentation for review by the Notified Body during the conformity assessments of Medical devices and IVDs. The guidance explains how to identify product categories ( (for Class IIa and Class B) and generic product groups (for Class IIb and Class C) . Manufacturers will need to utilize two "coding" systems: The MDA/MDN codes (MDR) or IVR codes (IVDR) according to Regulation (EU) 2017/2185, which is...

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