Industry UPDATE: NIOSH Requirements for N95 masks In response to the nation’s effort to control the spread of COVID-19, the NIOSH Respirator Approval Program is accepting and prioritizing applications received for new approvals and extension of approvals submitted by existing approval holders (both domestic and non-domestic manufacturers) and new domestic respirator manufacturers/applicants. NIOSH considers domestic
As of January 1, 2021, the UK’s departure from the EU will begin. As of that date, the Medicines and Healthcare products Regulatory Agency (MHRA) will take on the responsibilities for the medical devices market for the UK that are currently undertaken through the EU system. This calls for several changes to how medical devices
Applying for a New CPT Code For almost all medical devices associated with a medical or surgical procedure, there must be a corresponding CPT code. It’s simple – if there is no CPT code for those who perform the procedure to place on a billing claim to receive payment from insurers, providers will not use
mdi has been assisting clients in getting their medical devices licensed for Canada through the Health Canada offices. Many clients are now looking to see how they can get their medical devices to market faster using the Interim Order for Health Canada. This is the information that we have come up with for using the
Information on this Pandemic – Immunity from Liability If you were not up to date on this, on March 17, 2020, the United States Department of Health and Human Services (“HHS”) published a Declaration in the Federal Register providing immunity from liability under state and federal law to certain individuals and entities using medical countermeasures
Industry update MDR postponement – handle with care! The proposal for a one -year delay of Regulation (EU) 2017/745 on medical devices (MDR) that was proposed the European Commission has been confirmed by the European Parliament. The last step in the process will be a sign-off by the European Council. This is rather a formality
Environmental scanning of the reimbursement landscape, also known as reimbursement assessment, is a process that collects information on trends and priorities that impact or influence your medical device’s success in the marketplace. Performing an initial reimbursement assessment is important because it provides a baseline analysis of potential reimbursement gaps, risks, and opportunities for new medical
EU Approves New In-Vitro Diagnostic Device Regulation; Transition period has begun. On April 5, 2017, the European Parliament approved the new In-Vitro Diagnostic Device Regulation. This is the first major change in the IVD regulations. There is a five-year transition period following the formal publication of the IVDR for the industry to become compliant with
On Friday, April 13th, Health Canada released an update regarding their transition to the Medical Device Single Audit Program, also known as MDSAP. If you’re not familiar with or have not heard of the MDSAP as a new initiative yet, it is a new program that allows a company to conduct a single regulatory audit
People rely on medical device ranging from simple contact lenses to sophisticated pacemakers to improve the health and quality of life and so expect them to be safe and incorporate the latest progress in science and innovation. To reflect the substantial technological and scientific progress in this sector over the last 20 years, the European
mdi Consultants