Decomplix.com

Guidance on medical device significant changes under MDR

WebKey takeaways. Any “significant change” brought to a “legacy device” still CE-marked under the former Directives entails the loss of the legacy status and requires …

Actived: 7 days ago

URL: https://decomplix.com/medical-device-significant-changes/

Which MDR requirements apply to distributors of medical devices

WebWhich requirements does the QMS have to fulfil? To learn more about requirements for a distributor’s QMS, the document of the Medical Device Coordination …

Category: Medical Go Health

Swiss Authorized Representatives for Medical Device

WebThe rules for placing medical devices or IVDs on the Swiss market have significantly changed since 26 May 2021 for medical devices that are not IVDs and since …

Category: Medical Go Health

Intended Purpose Under MDR

WebThe EU MDR defines the intended purpose in Article 2 (12) as follows: ‘Intended purpose’ means the use for which a device is intended according to the data …

Category: Health Go Health

Medical device software (MDSW) under EU MDR and IVDR

WebBeing intended for the benefit of individual patients. MDSW is software intended to be used (alone or in combination) for any of the purposes described in the …

Category: Health Go Health

UDI for Medical Device Software (MDSW) under EU MDR

WebThe UDI code, to be assigned (and maintained) by the manufacturer for any medical device CE-marked under the EU MDR. The obligation to assign UDI codes …

Category: Medical Go Health

Annex XVI and EU MDR – Guide to regulation of products

WebThe classification rules 9 and 10 in EU MDR Annex VIII refer to an intended medical purpose, i.e. therapy and diagnosis, respectively, which cannot be applied to …

Category: Medical Go Health

Clinical evaluation of medical devices under the EU MDR

WebConformity assessment of a medical device under the MDR requires a demonstration that the device meets the general safety and performance requirements …

Category: Medical Go Health

Risk Management for Medical Devices under EU MDR and ISO 14971

WebRisk management is required by law through the new Regulation (EU) 2017/745 on medical devices (EU MDR), to ensure that medical products are safe for …

Category: Medical Go Health

Post-Market Surveillance

WebPost-market Surveillance (PMS) under the new Regulations (EU) No. 2017/745 on medical devices (EU MDR) and 2017/746 on in-vitro diagnostic devices …

Category: Medical Go Health

Medical device and IVD Vigilance in EU and Switzerland

WebAnnex E – Health impact/effects; IMDRF AET codes and terms must be embedded in the manufacturer’s complaint management and Vigilance systems for …

Category: Health Go Health

Medical Device Regulatory Strategy for US & EU Markets

WebAnimal health: medical devices for veterinary use are covered in the definition of medical device in the US but fall outside the scope of the definition in the …

Category: Medical Go Health

Person Responsible for Regulatory Compliance (PRRC) & MDR

WebReplaces the version of 11.08.2020. Key takeaways: EU MDR and IVDR introduce the role of the Person Responsible for Regulatory Compliance (PRRC). …

Category: Health Go Health

Understanding ISO 13485

WebISO 13485 is meant to help medical device companies (primarily medical device manufacturers) set up a QMS that demonstrates consistent design, development, …

Category: Medical Go Health

Understanding Harmonized Standards for medical devices and IVDs

WebHarmonized standards are the basis to demonstrate conformity with the General Safety and Performance Requirements for medical devices and IVDs. The …

Category: Medical Go Health

“Legacy” medical devices and IVDs under EU legislation

WebLegacy devices under the EU MDR and IVDR are those devices allowed to be placed on the market after the date of application of the corresponding regulation (i.e. …

Category: Health Go Health

Medical device regulatory strategy and gap analyses

WebDecomplix’ medical device regulatory strategy. and gap analyses service includes: We provide strategic plans including estimated timelines and costs to choose the most …

Category: Medical Go Health

EU MDR/IVDR & MedDO/IvDO consulting

WebWith her extensive regulatory expertise, she supports Decomplix’ customers both on strategic levels and on detailed regulatory questions. Contact. …

Category: Health Go Health

Swiss medical device importers – regulatory requirements

WebWhy is a Swiss Importer suddenly needed for medical devices, incl. in-vitro diagnostic devices (IVDs)? Importing CE-marked medical devices (including IVDs) into …

Category: Medical Go Health