Are you a global medical device organisation without a physical location in Europe? Of course, you are aware of the medical device regulation MDR 2017/745 mandatory requirement to appoint an EU Authorised Representative [(AR) or (EC REP)] to represent your company to the European competent authorities. Remember, this legal obligation is applicable for the marketing …
Continue reading “Authorised Representatives: Effective Collaboration Required”
Revenue Streams: Only as Strong as the Weakest Link
What does your China regulatory strategy look like?
Internal regulatory data and intelligence is an often forgotten, yet critical source of information. Every organisation’s electronic files provide a rich source of data for strategic registration planning and policy creation.
LinkedIn identifies 162 followers of #combinationproducts whereas the values for followers of #medicaldevice and #pharmaceuticals are 42 thousand and >1 million respectively.
Instem provides advanced and best-in-class IT solutions & services to the global life sciences community to improve the productivity of their processes in the discovery and development of new drugs (human and veterinary), medical devices, invitro diagnostics, therapies and products. Instem delivers these software solutions and services across the entire lifecycle of product development, from …
I recently attended a brilliantly presented BSI webinar entitled: “UKCA for Medical devices and IVDs, are you ready?” which provided additional insight and confirmation of the UKCA conformity assessment process. I also propose a heartfelt thank you to Dr. Jayanth Katta for taking his time to provide the medical device and IVD industries with guidance. …
As of 23.00 on 31st December 2020 the United Kingdom officially (and finally) withdrew as a member of the European Union (EU). Firstly, a geography lesson: the sovereign nation commonly known as the United Kingdom consists of the island of Great Britain (England, Scotland and Wales) and the north east part of the island of …
Devices without a medical purpose are excluded from the scope of the Medical Device and Active Implantable Medical Device Directives, however a group of such products are now regulated in the Medical Device Regulation 2017/745 due for application on 26 May 2021. The rationale behind their inclusion is based upon potential unreasonable risks these device types may impart upon use. The legislation applies to these products regardless of whether the point of use is at home by the end consumer or in a healthcare professional setting.
The United States Department of Health and Human Services (HHS) is considering making permanent and/or keeping as temporary the regulatory standards and amendments promulgated in response to the COVID–19 crisis, issued in order to improve early access to care and reduce costs.
