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Medical device product fault reporting the to the US FDA
Do I need to report a medical device product fault to the US FDA? In the unfortunate event that an undetected manufacturing defect is found in a medical device, or there is an error in the use of the product, or other safety problems are encountered during the...
EU Post Market Surveillance – Transitional Requirements for Medical Device Manufacturers
The transition of the medical device industry in the European Union to the Medical Device Regulations 2017/745 is now well underway. Thousands of manufacturers are now successfully certified to the new regulation, and more certifications are being issued each week....
Planning and Process for Compliant Post-Market Surveillance
Deadlines for Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) implementation have been pushed back once more. This may induce some manufacturers to procrastinate with a number of MDR compliance...
Borderline products and the new UK Medical Device Regulations: what’s changing?
The MHRA intends to bring certain aesthetic and another non-medical purpose products under the scope of the UK medical devices regulations for the first time. They intend to do this where the product function and risk profile are seen as being similar to medical...
Medical device legacy status: new definition and requirements
In March the European Commission reached a decision regarding the MDR/IVDR transition period that has been extend until 31st December, 2027 or 31st December, 2028, as applicable[1]. The MDR/IVDR Amendment, Regulation 2023/607 (Transitional Provisions)[2] was published...
Medical Device Expansion into the Middle East and North Africa
This is the second short article in a 3-part series authored by Daniel English, Regulatory Affairs Consultant at IMed Consultancy. This article follows on from Part 1 and considers medical device opportunities and market expansion into the international marketplace....
PMS and patient safety: shifting to a proactive approach
Despite deadlines for the EU MDR 2017/745 and the EU IVDR 2017/746 (IVDR) implementation being pushed back once more, certain aspects of the MDR that are closely linked to patient safety, such as the need for cyclical and proactive Post Market Surveillance (PMS), are...
Latest Medical Device industry trends from Medical Technology UK 2023
Medical Technology UK in Coventry is the exhibition and learning place for medical device engineers in the UK. The team at IMed Consultancy could not miss out on this key opportunity to mingle with over 130 specialist suppliers, with a large contingent of both young...
UKCA opportunity – A compelling case for UK market access and commercial opportunity
The medical device regulatory environment is undergoing unprecedented upheaval especially in Europe and the UK. On the one hand the phased introduction of the EU MDR and IVDR are increasing pressures on manufacturers to prove the ongoing safety of their devices, if...