Tag: Medical Devices

MedTech EU issues MDR/IVDR reform statement after EPSCO |

MedTech Europe issued an MDR/IVDR statement after EPSCO meeting discussing the MDR and IVDR. Whereas clinical evidence forms the foundation of patient and user safety, clinical is not mentioned anywhere. While supporting this statement in general, the phrase that the EU commission should act swiftly – indeed they should – and implement solutions to “Significantly […]

NEW DECLARATION OF HELSINKI – HOW BIG IS THE IMPACT? |

Draft version of new ISO 14155 published for voting |

https://www.iso.org/standard/83968.html A new version of ISO14155 is currently under development, and on 20-JUN-2024 ISO/DIS 14155, replacing ISO14155:2020 when ready, entered the voting phase that terminates on 12-SEP-2024. A couple of interesting elements are in (potentially) impacting riskmanagement and safety for medical device clinical investigations (note the scope seems to have widened no longer excluding IVDs), […]

EU Commission issues updated timeline for EUDAMED |

EU commission issues an updated planning for gradual roll out of the EUDAMED modules, however, the timeline for delivery of the clinical investigations / performance studies module has been set yet. In other words we are still stuck with local approaches when it comes to adverse event reporting to the regulatory bodies involved in clinical […]

MDCG issues guidance on clinical evaluations for orphan devices |

https://health.ec.europa.eu/document/download/daa1fc59-9d2c-4e82-878e-d6fdf12ecd1a_en?filename=mdcg_2024-10_en.pdf By nature ‘orphan devices’ are intended for use in a small number of individuals. This leads to specific challenges for manufacturers and notified bodies on the clinical evidence requirements for the purposes of MDR certification. This MDCG guideline presents guidance on circumstances where it is acceptable to place an orphan device on the market […]

MDCG issues guidance on content and synopsis of the Clinical Investigation Plan for Medical Device studies |

The MDCG issued guidance regarding the content and the synopsis of the Clinical Investigation Plan (CIP) for Medical Device studies.   A quick review learns there are no big surprise here: to name a few.

PREVENTING THE BIG SCARE WHEN YOUR NEXT CLINICAL EVALUATION IS DUE: THE HIDDEN WAKE-UP CALLS FOR LEGACY MEDICAL DEVICES.

How do you keep your legacy medical devices CE marked once the Medical Device Regulation (MDR)  applies in May 2021? Can you continue to do what you did under MDD and are you then OK? A month ago, the Medical Device Coordination Group (MDCG) released a guide with the “how to’s” in MDCG 2020-6, a […]