ISO11607 defines and uses three seemingly similar terms: “Sterile Barrier System”, “Protective Packaging”, and “Packaging System”. These terms each have a distinct meaning and usage within the standard, and a precise understanding of the differences is critical when planning and executing packaging validations. In this post we dissect the definitions and usage of these three […]
Will the EU Medical Devices Regulations certificate cliff edge in 2024 be avoided?
February 10, 2023 by
The European Commission’s Medical Device Coordination Group (MDCG), has undertaken a survey to collect data on notified body certification and application activities under the Medical Devices Regulation (EU 2017/745) (MDR) and In Vitro Medical Devices Regulation (EU 2017/746) (IVDR). The MDCG is composed of representatives of Member States and chaired by the EU Commission. Previous MDCG recommendations in […]
Medical Technology International Business Opportunities
February 8, 2022 by
Trade Mission to the UK and Finland In November 2021, I had the honor to represent the MDRG and the state of Minnesota on the Governor’s Trade Mission to the UK and Finland. Our mission of 70 was comprised of four tracks: Medical Technology, Environmental Technology, Food and Agriculture, and Education. MedTech Track The Medical […]
UK Conformity Assessment (UKCA) marking comes into effect
February 5, 2021 by
Following the end of the Brexit transition period, the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) will not be transposed into law in Great Britain. In this context, it is important to be aware of the distinction between Great Britain – England, Scotland and Wales – and the United Kingdom, which comprises Great […]
Changes in the European Medical Devices Regulations now require traceability of Medical Devices
October 9, 2020 by
Historically, companies selling implantable medical devices in Europe have not been required to provide patients with device-specific information. In the event of a medical emergency, not having immediate access to this critical information predisposes the patient to a variety of unnecessary operational risks.That changed with the European Medical Devices Regulation (MDR) modifications approved by European […]
Understanding the biological effects of medical packaging in the assessment of a medical device.
June 17, 2019 by
For many years Toxikon has been performing biocompatibility testing of medical devices. Biocompatibility testing is a risk/benefit approach in understanding the safety of a medical device or product. That process can be pretty simple, using the guidance of ISO 10993 and regulatory guidance for industry. Resources like ISO 10993-1 and the FDA’s guidance available today […]
What does Brexit mean to your Medical Device Company?
February 15, 2019 by
The UK Parliament has rejected Prime Minister Theresa May’s Brexit plan (January 15, 2019). This does not make predicting the future easier. It is possible that the government will come back with a new plan, or, there will be a no-deal Brexit. In the case of a no-deal Brexit, the EU will not accept UK […]