MedBoard & Easy Medical Device Regulatory Update Report

Medtech Regulatory Update - Monthly Podcast

March 2023 Podcast Episode

Easy Medical Device and MedBoard collaborate to bring you the Top MedTech Regulatory News of the Month.

See other months

Podcast Footnotes by MedBoard:

European Union / TEAM-NB Event · 2023-03-02 New Team-NB initiative: IVDR Technical Documentation Training for Manufacturers
European Union / TEAM-NB Guidance · 2023-03-01 Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of In Vitro Diagnostic Medical Devices Regulation
European Union / EMA Notice · 2023-02-27 EMA pilots scientific advice for certain high-risk medical devices
European Union / EC Notice · 2023-02-18 National Standards Authority of Ireland (NSAI), 10th Notified Body designated under IVDR (EU) 2017/746
European Union / EC Notice · 2023-02-16 MDC MEDICAL DEVICE CERTIFICATION GMBH, 9th Notified Body designated under IVDR (EU) 2017/746
European Union / EC Guidance · 2023-02-14 MDCG 2023-3 - Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices
European Union / EC Event · 2023-02-07 Day 1: 27 March 2023 Joint IMDRF / Stakeholder (DITTA-GMTA) Workshop
European Union / EC Event · 2023-02-07 Day 2: 28 March 2023 IMDRF Stakeholder Forum
United Kingdom (UK) / MHRA Notice · 2023-02-20 Impact of extension of Medical Device Regulations transitional period and the validity of certificates in the EU
United States of America (USA) / FDA Report · 2023-02-14 List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools)
United States of America (USA) / FDA Report · 2023-02-03 MedSun Newsletter, February 2023
Brazil / ANVISA Guidance · 2023-02-27 Medical Device Clinical Evidence Guide - Concepts and Definitions
Brazil / ANVISA Guidance · 2023-02-27 Medical Device Clinical Evaluation Guide
Brazil / ANVISA Guidance · 2023-02-27 Medical device Clinical Investigation Guide
Switzerland / Swissmedic Guidance · 2023-02-17 BW630_30_010e_MB FAQ on in vitro diagnostic medical device notifications
Germany / BfArM Notice · 2023-02-08 Companion diagnostics (CDx)
Global Harmonization Working Party / GHWP Guidance · 2023-02-27 GHWP/WG2-WG1-WG3/F001:2023 - Categorisation of Changes to a Registered Medical Device
Global Harmonization Working Party / GHWP Media · 2023-02-23 Annex 6 - IMDRF Status Updates
Global Harmonization Working Party / GHWP Media · 2023-02-23 Annex 16 - European Union Updates
Global Harmonization Working Party / GHWP Guidance (Draft) · 2023-02-07 GHWP/WG2-WG1-WG3/P001:2023 - Categorisation of Changes to a Registered Medical Device (Proposed Document)
Ireland / HPRA Form · 2023-02-10 Article 97 Request Form - Request by a Manufacturer / Authorised Representative in accordance with MDCG-2022-18
Saudi Arabia / SFDA Event · 2023-02-27 Saudi Unique Device Identification (SAUDI-DI) for Medical Devices Requirements & Submission process
Saudi Arabia / SFDA Event · 2023-02-27 The Requirements for Clinical Evaluation Report of Medical Devices
Saudi Arabia / SFDA Form · 2023-02-16 Agreement between a single legal manufacturer and an authorized representative
Saudi Arabia / SFDA Form · 2023-02-16 Agreement between an organization representing multiple legal manufacturers within a single company and an authorized representative
Italy / Ministry of Health Notice · 2023-02-02 Breast implants, the mandatory national register is underway
South Africa / SAHPRA Guidance · 2023-03-01 Guideline on Questions and Answers Licensing of Medical Device Establishments
South Africa / SAHPRA Notice · 2023-02-08 Importing And Operating Unlicensed Dental X-Ray Equipment
Spain / AEMPS Notice · 2023-02-16 The AEMPS publishes a notice addressed to notified bodies and manufacturers of nasal sprays with virucidal or microbicidal action

Like Monir, Use MedBoard for creating your Regulatory Intelligence program and be on top of news, changes and actions.

Learn More Here

The MedBoard Company 2023 ©

Try MedBoard.com for free

HQ: Leeds (United Kingdom)

MedBoard

Custom Questions Reasons for Exclusion Score Calculations Custom Keyword Highlighting Review Framework

Review Step

What is the value for the professional

Review Status

Criteria for this Review Status

Templates

Copy questions from another Systematic Review Add Question

Sort	Id	Review Phase	Question	Answer Type	Answers	Actions
				Free Text Numeric Single Select Multi Select Table IMDRF AER Codes	Free text answer Every item in: IMDRF AER Codes - Section A IMDRF AER Codes - Section B,C,D IMDRF AER Codes - Section E,F IMDRF AER Codes - Section G (Score: ) Numeric values answer See table

Templates

Add Column

Configuration for table ""

Sort
Id
Column Name
Answer Type	Free Text Numeric Single Select
Answers	Free text answer
Edit

Forms

These are Form Templates, collections of custom questions created either by MedBoard or by your Company that you can add to the Systematic Review Appraisal.

Create Form

Add Form to Appraisal

question(s)

There are no template questions in this form yet

Sort	Id	Review Phase	Question	Answer Type	Answers	Actions
				Free Text Numeric Single Select Multi Select Table IMDRF AER Codes	Free text answer Every item in: IMDRF AER Codes - Section A IMDRF AER Codes - Section B,C,D IMDRF AER Codes - Section E,F IMDRF AER Codes - Section G (Score: ) Numeric values answer See table

Create Question for this Form

Single Questions

These are Single Custom Question Templates that you can add to the Systematic Review Appraisal.

question(s) Create Question

Id	Review Phase	Question	Created By	Answer Type	Answers	Add to Appraisal	Actions
				Free Text Numeric Single Select Multi Select Table IMDRF AER Codes	Free text answer Every item in: IMDRF AER Codes - Section A IMDRF AER Codes - Section B,C,D IMDRF AER Codes - Section E,F IMDRF AER Codes - Section G (Score: ) Numeric values answer See table		Edit Copy Unpublish Publish Delete

Column name Enter the question

Description (this can give more context to help AI suggestions)

Choose the type of answer It's not possible to change the answer type of an existing column question

To configure the columns for this table you need to save it first.

Choose the section It's not possible to change the answer type of an existing column question

Add all possible answers. Optionally, you can also add scores (whole numbers) Add all possible answers All answers from IMDRF are already loaded automatically. If you wish to add any additional answers, please enter them below:

Answer

Score

Add

Answer	Score	Action

Deleting answers will impact existing Reviews that previously used those answers

No answers yet...

This question is applicable to which review phase:

Add a Score Calculation

Id	Score Calculation Name	Type	Questions	Options
			+ ( + ) / x

Require a Reason for Exclusion when marking items as Not Relevant

Copy Reasons for Exclusion from another Systematic Review Add Reason for Exclusion

Order	Id	Reasons for Exclusion	Options

Highlight keywords for inclusion

Add

No inclusion keywords yet

Highlight keywords for exclusion

Add

No exclusion keywords yet

Score	Description

Score	Description