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Our head of Regulatory Ed Drower was just recently interviewed on the Easy Medical Device Podcast to discuss MDR Literature Search best practices and other research topics.
Latest Publications
Look here for Industry updates and technical tutorials written by the CiteMed staff. All things Medical Device Regulation are covered in our publications.
Are You Over Committing on Your EU MDR Post Market Surveillance Plan?
The EU MDR and IVDR will usher in increased post market surveillance (PMS) requirements for all MedTech companies, mandating a PMS plan that includes a Post-Market Clinical Follow-up (PMCF) plan or justification for why it [...]
Classifying Software as Medical Device in EU MDR
Introduction to Software as a Medical Device in MDR The MDCG’s Guidance document defines the criteria for the qualification of software falling within the scope of the EU MDR and IVDR, and seeks to elucidate which [...]
How to Hire a Literature Search Writer and What to Look For
How to Hire an EU MDR Literature Search (or CER) Writer and What to Look For With the upcoming transition to the EU MDR ( Medical Device Regulation (MDR) 2017/745) in May 2021, medical device manufacturers [...]
UK details a post-Brexit medical device regime starting January
With ongoing negotiations over a trade deal between the UK and the EU and less than 30 days until the end of the Brexit transition period, the UK Government continues to flesh out guidance [...]
Post-Brexit Medical Device Regulatory Compliance – UK MHRA Guidance
In accordance with the guidance posted by the UK Medicines and Healthcare products Regulatory Agency (MHRA), from 1 January 2021 the MHRA will undertake the responsibilities for the UK medical devices market, previously under [...]
Your NB’s Clinical Evaluation Assessment Report
MDCG’s Guidance document, released in July 2020, introduces and details the key requirements and format of a Clinical Evaluation Assessment Report (CEAR) to be documented by Notified Bodies (NBs) as a part of its [...]