Next Update: 22nd October 2018

18th October 2018

 

  • Australia (TGA): New Regulatory Reform 

    Patient implant cards and consumer device information leaflets [Open] 

 

  • USA (FDA):  New Guidance  

Content of Premarket Submissions for Management of Cybersecurity in Medical Device [Open]

15th October 2018

 

  • UK (MHRA): New Guidance

Guidance for products without an intended medical purpose (Annex XVI) under the new Medical Device Regulation (EU 2017/745) [Open]


  • USA (FDA): New Communication 

Cybersecurity Updates Affecting Medtronic Implantable Cardiac Device Programmers: FDA Safety Communication [Open] 

 

  • Canada (Government of Canada): New Notice 

Notice: Classification of Medical Devices used to Deliver Drugs by Smoking [Open] 

 

  • Australia (TGA): Updated Guidance  

Patient implant cards and consumer device information leaflets [Open] 

 

  • Australia (TGA): Updated Guidance 

Fees and charges [Open] 

 

  • Hong Kong (Body): New Process 

To facilitate the classification of an in vitro diagnostic medical device according to its risk level under the Medical Device Administrative Control System, a "Web-based In Vitro Diagnostic Medical Device Classification Programme" has been developed and posted for your use. [Open]

 

11th October 2018

 

  • United Kingdom(MHRA): Updated Guidance 

Notify MHRA about a clinical investigation for a medical device [Open] 

Information about rules of processing notifications about clinical investigations by MHRA during period of Christmas 2018 

 

  • European Commission (EC):  New Guidance  

MDCG 2018-3 Guidance on UDI for systems and procedure packs [Open]

 

  • European Commission (EC):  New Guidance  

MDCG 2018-4 Annex: UDI database Definitions/Descriptions and formats of the UDI core elements for systems or procedure packs [Open]

 

  • European Commission (EC):  New Guidance  

MDCG 2018-5 UDI Assignment to Medical Device Software  [Open]

 

  • European Commission (EC):  New Guidance 

MDCG 2018-6 Clarifications of UDI related responsibilities in relation to Article 16 of the Medical Device Regulation 2017/745 and the In-Vitro Diagnostic Medical Devices Regulation 2017/746  [Open]

  

  • European Commission (EC):  New Guidance 

MDCG 2018-7 Provisional considerations regarding the language issues associated with the UDI database (Annex VI, Part A Section 2 and Part B of the Medical Devices Regulation 2017/745 and the In-Vitro Diagnostic Medical Device Regulation 2017/745 [Open]

 

  • European Commission (EC):  New Guidance 

Field Safety Notice [Open] 

 

  • European Commission (EC):  New Guidance 

Field Safety Notice - Customer reply  [Open]

 

  • European Commission (EC):  New Guidance 

Field Safety Notice Distributor/Importer Reply [Open]

 

  • European Commission (EC):  New Guidance 

Questions and Answers to fill in the Field Safety Notice [Open] 

 

  • European Commission (EC):  New Guidance 

State-of-play of joint assessments of Notified Bodies in the medical device sector [Open] 

 

  • European Commission (EC):  New Guidance 

MDR and IVDR implementing measures rolling plan [Open]

 
 
 

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