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. …
Author Archives: Kim Young, Director Global Regulatory Intelligence
Brexit for Medical Devices
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 …
Beautification regulated as medical devices: MDR Annex XVI
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.
Yay or Nay: Comments Requested on US EUA Policies
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.
Taiwan UDI Draft Guideline – Highlights
On 05 November 2020, the TFDA published a new draft guidance document for public consultation. The guidance document, “Requirements for the Single Identification Code to be Published on the Labels of Medical Devices”.
China UDI:Medical Devices
On 10 August 2020 the NMPA launched Unique Device Identification (UDI) Database on its website.
EU Authorised Representative: A Very Important Person
If your organisation does not have a physical location in Europe, you are required, by the medical device regulation MDR 2017/745, to appoint an EU Authorised Representative (AR) or (EC REP) to represent your company to the European authorities. If you do not appoint a representative, your products destined for the EU market may be stopped at the border.
Global UDI and Reg Ops Impact
UDI data compliance adds an additional layer of complexity to an already resource stretched team. Managing the regulatory data across regions, languages, timezones and facilities without a robust and efficient process is not sustainable. Non-compliance is not an option.
Why are you not ready?
If an organisation is still asking basic questions today, at 233 days (5352 hours) until application of MDR, when will they actually be prepared??
Are your EU distributors ready for 26 May 2021??
European Regulatory requirements1DISTRIBUTORS of medical devices or in vitro diagnostic devices have specific obligations to fulfil under Article 14 of both the MDR and IVDR.2,3 Distributors will have to verify whether: the device has the (CE) mark and an EU Declaration of Conformity has been issued; the importer’s name is affixed on each device or is …
Continue reading “Are your EU distributors ready for 26 May 2021??”
