Medical Devices

The EU Medical Device Regulation: Balancing innovation with regulation
2025-02-07T12:32:00+00:00
November 2024 – Contents
2024-12-06T15:14:00+00:00
Medical device standards update: December 2024
2024-12-06T11:54:00+00:00
Greater post-market surveillance for medical devices
2024-11-21T17:20:00+00:00
MD5/IVD5: Responsible and experienced PRRCs for MDR and IVDR
2024-11-08T06:57:00+00:00
MD4/IVD4: UK MDR – Current requirements and future perspectives for medical devices and in vitro diagnostics
2024-11-08T06:56:00+00:00
MD3/IVD3: The impact of MDR/IVDR and its effect on future developments of policies, manufacturers and inspectorates
2024-11-08T06:56:00+00:00
HM5/MD1/IVD1: COMBINE project: A new era of combined clinical trials in Europe
2024-11-08T06:52:00+00:00
November 2024 – Contents: Medical devices/IVDs sessions
2024-11-07T17:26:00+00:00
Borderline products and self-care in the digital age
2024-09-13T12:16:00+01:00
Sustainable design and manufacture in medical devices
2024-08-13T10:00:00+01:00
New approach methodologies for the biological safety assessment of medical devices
2024-08-13T10:00:00+01:00
E-labelling: revolutionising the labelling landscape
2024-08-13T10:00:00+01:00
What is involved in the role of the person responsible for regulatory compliance (PRRC)?
2024-08-13T10:00:00+01:00
The sustainability imperative for the healthcare sector
2024-08-13T09:56:00+01:00
The UK Responsible Person Association
2024-06-11T15:30:00+01:00
RegRapPod − May 2024
2024-05-08T16:30:00+01:00
Medical device standards update: March 2024
2024-05-08T10:30:00+01:00
The European Association of Authorised Representatives
2024-05-08T10:30:00+01:00
RegRapPod − April 2024
2024-04-13T00:05:00+01:00
Device submissions for combination products: a data-driven perspective
2024-04-03T12:00:00+01:00
Sponge-on-a-string cuts wait time for Barrett’s diagnosis
2024-03-20T15:00:00+00:00
March 2024
2024-03-01T00:05:00+00:00
February 2024
2024-02-08T00:05:00+00:00
Sink or swim: the changing tides of device regulation
2024-02-08T00:05:00+00:00
February 2024 – Contents
2024-02-08T00:05:00+00:00
Chemical characterisation: a critical first step for medical device development
2024-02-08T00:05:00+00:00
Overview of medical device regulations in Canada
2024-02-08T00:05:00+00:00
AI meets medtech:
big opportunities
require a
measured approach
2024-02-08T00:05:00+00:00
The rise of FemTech and why compliance is key to its success
2024-02-08T00:05:00+00:00
EU MDR implementation – what is changing for the medical device industry?
2024-02-08T00:05:00+00:00
MD3: Navigating the regulatory maze: challenges of medical device software
2023-12-07T00:00:00+00:00
MD2/IVD2:
Medical technologies −
a catalyst for
regulatory innovations
2023-12-07T00:00:00+00:00
MD5: Post-market challenges
2023-12-05T16:00:00+00:00
IVD5: Class D IVDs
2023-12-05T16:00:00+00:00
MD4: Challenges and opportunities for small companies and start-ups
2023-12-05T16:00:00+00:00
IVD4: How to manage diverging regulatory strategies within a global market (China, US and the EU)
2023-12-05T16:00:00+00:00
IVD3: IVDR: Current state
2023-12-05T16:00:00+00:00
Medical device standards update: November 2023
2023-11-03T00:05:00+00:00
FDA to establish Digital Health Advisory Committee
2023-10-31T11:28:00+00:00
Optimal materials selection in medical device development – a proactive biocompatibility approach
2023-10-02T15:30:00+01:00
Rapid COVID-19 breath test device shows promise
2023-08-04T15:02:00+01:00
Regulatory challenges and opportunities facing hearing aid manufacturers in Europe
2023-08-03T15:00:00+01:00
A year of clinical trials under IVDR:
a sponsor’s perspective
2023-08-03T15:00:00+01:00
Impact of clinical data requirements following EU MDR (2017/745) & Clinical Evaluation Guidance (MEDDEV 2.7/1 Rev 4)
2023-08-03T14:59:00+01:00
Dementia patients retain ability to learn using devices: study
2023-07-10T09:12:00+01:00
Wearables can spot Parkinson’s up to seven years earlier
2023-07-05T14:19:00+01:00
Change Across the Medical Device Landscape
2023-06-23T15:39:00+01:00
Medical device standards update: June 2023
2023-06-23T14:00:00+01:00
Neuralink gets FDA approval for its first brain device trials
2023-06-06T11:27:00+01:00
IMDRF: Origins, purpose and current work
2023-03-07T13:29:00+00:00
European medicines and medical devices: Future trends
2023-03-07T13:28:00+00:00
Understanding key components of a clinical evaluation
2023-03-03T12:29:00+00:00
Regulation versus innovation in life sciences
2023-02-07T09:27:00+00:00
IVDs and medical devices — post-market surveillance and clinical follow-up requirements
2023-02-07T09:27:00+00:00
Successful transition of your ISO 13485 QMS from MDD/IVDD to MDR/IVDR
2023-02-07T09:25:00+00:00
November 2022 – Contents
2022-11-14T10:13:00+00:00
Medical device standards update: September 2022
2022-10-31T14:41:00+00:00
Navigating the MDR’s heightened surveillance and performance requirements
2022-09-16T09:25:00+01:00
EU expert panels for high-risk devices - another level of review?
2022-09-16T09:25:00+01:00
The importance of subjective and qualitative risk management for medical devices regulation
2022-09-16T09:25:00+01:00
The new UK MDR - a great start to a long road ahead
2022-09-16T09:25:00+01:00
One year experience on EU Medical Devices Regulation (MDR) 2017/745 for single integral drug-device combination products
2022-06-23T10:39:00+01:00
Translating digitalisation trends into tangible solutions
2022-06-22T15:51:00+01:00
What can past decision-making data tell us about how the FDA will make future combination product categorisation decisions?
2022-05-26T11:04:00+01:00
Medical device standards update: February 2022
2022-05-25T10:27:00+01:00
Practical insights into the recent EU MDR framework
2022-04-18T13:18:00+01:00
The national competent authorities of Belgium and Luxembourg share their views about the e-PIL Pilot
2022-03-24T11:24:00+00:00
Planning for the future: sustainable medical devices
2022-03-24T10:50:00+00:00
Electronic leaflet pilot in Belgium and Luxembourg hospitals
2022-03-23T11:07:00+00:00
A review of Project Orbis: An initiative enabling faster patient access to cancer therapies
2022-02-23T14:16:00+00:00
New regulatory tools for drug developers: sharing experience
2022-01-24T14:21:00+00:00
Substance-based medical devices: regulatory challenges and prospects
2021-12-23T13:59:00+00:00
MD4: Clinical investigations – Is coordinated CA assessment the future?
2021-11-23T14:25:00+00:00