Our Best EU MDR Whitepapers and Templates
EU MDR Gap Analysis
The first step any Regulatory Affairs or Quality teams takes is to (hopefully) read through the latest medical devices regulation and identify which components are missing to go from Old -> New for each of your medical devices.
In terms of the new EU Regulation (MDR), it’s likely that your Post Market Surveillance, Clinical Evaluation, and Bio-compatibility testing fall short. Fortunately, there are now several great templates and checklists available for helping you structure that medical device gap analysis.
Medical Device CER and Literature Search and Review
It’s almost guaranteed that your CER will need an overhaul to conform going forward. Expanded Literature Search is a major element of a new bulletproof MDR CER. Additionally, there is a noticeable move away from the ‘Essential Requirements’ list in Meddev towards the GSPR’s in MDR. You will need to restructure your CER to hit all of these new safety and performance requirements.
The CiteMed team is incredibly experienced drafting (and saving!) CERs for MDR. However, our real talents shine when it comes to delivering a comprehensive and modular Literature Review to be included within the CER. These literature reviews will leave your Notified Body Assessor with no doubt that you covered every possible angle when it comes to the safety and efficacy of your medical devices. It also addresses State of the Art in your device’s industry which has become increasingly scrutinized by Notified Bodies.
EU MDR Post Market Surveillance
Your medical device PMS plan will need to be bolstered in order to meet MDR standards. So far the regulations are very explicit about increased intervals of reporting and responsibilities…but they have not been as clear in stating the exact contents of each type of report. This creates a lot of uncertainty for medical device manufacturers.
Confusion around the various types of PMS reporting (Vigilance, Safety Update Reports, Clinical Followup) has inspired our team to write up an extensive guide to Post Market Surveillance (for manufacturers attempting to buy services from consultants). We have also given our Literature Review System an upgrade to be used when searching and compiling clinical data for your own reports. Check out our papers and if you have any questions about how we can help you nail PMS year after year (without spending much of your time or budget) then drop us a line.
- A Manufacturer’s Buying Guide (Coming Soon!)
- EU MDR – Post Market Surveillance Templates
Medical Device Clinical Evaluation Reports under EU MDR
Five Practical Tips for Writing a Compliant Clinical Evaluation Report (CER)
Even for experienced medical writers and regulatory staff, writing a compliant clinical evaluation report (CER) for medical devices can be tricky. Regulations and guidelines change, as does the attitude of the notified bodies. A [...]
Updates of the MDCG 2019 9 Rev 1, SSCP, and Others
The term summary of safety and clinical performance has recently sent the medical manufacturing world into a buzz. The new MDCG 2019 9 update published by the EU comes with some new rules for the [...]
IVDR: General Principles of Clinical Evidence for In Vitro Diagnostic Medical Devices (IVDs)
A year into the EU Medical Device Regulation (MDR 2017/745), it is safe to say the implementation of the MDR has been complicated, for both manufacturers and the notified bodies. Even though the European Parliament [...]
The Relationships Between Literature Search and CER and PMS Vigilance, PMCF, and PSURs
A systematic review of the literature, including both peer-reviewed and grey literature (e.g., conference abstracts), is recommended as part of a clinical evaluation report or CER and the post-market surveillance of medical devices. The [...]
Clinical Evaluation Report (CER) vs. Periodic Safety Update Report (PSUR)
Every medical device on the European market must be continuously monitored to confirm its safety and efficiency for patients and users. The EU MDR (2017/745) requires clinical evaluation and post-market surveillance programs to ensure [...]
Managing Clinical Evaluation Report (CER) and Literature Review Teams
Being a medical device manufacturer involves more than the actual manufacturing of the medical devices. A manufacturer's job is not only to come up with a device that will be beneficial to the patient population, [...]
Medical Device Literature Search and Review under EU MDR
Literature Search: How Much Research is Enough?
The research process is often thought of as a linear, straightforward path. You begin with a question and then proceed to find the answer. But, in reality, research is a messy process that often involves [...]
Term Refinement in Literature Search
A literature search is a systematic search through existing data in an organized way to determine an extensive range of quality references to a specific subject. Literature searches serve many functions for a medical [...]
Can Artificial Intelligence Technology Tame Literature Review?
When one tries to publish in an international journal these days, they inevitably encounter an obstacle: researchers around the world have more than likely published thousands of papers on a similar topic, which could need [...]
The Relationships Between Literature Search and CER and PMS Vigilance, PMCF, and PSURs
A systematic review of the literature, including both peer-reviewed and grey literature (e.g., conference abstracts), is recommended as part of a clinical evaluation report or CER and the post-market surveillance of medical devices. The [...]
Performing Effective Literature Search – For EU MDR and Other Regions
For any medical device, there must be sufficient clinical evidence to corroborate compliance with relevant essential requirements for safety and performance. One of the most crucial components for a thorough and complete Clinical Evaluation [...]
Why you Need a Great Literature Review
The work of a literature review is not merely to be submitted as a part of the submission document. A good literature review can do half of the job for the marketers developers alike, all [...]
Post Market Surveillance for EU MDR
Post-Market Surveillance, Market Surveillance, and Vigilance – What is the Difference?
Most regulatory staff can define post-market surveillance relatively succinctly. Perhaps also vigilance. But when it comes to market surveillance, what exactly makes it different from post-market surveillance? And why is vigilance a separate entity [...]
Post-Market Clinical Follow-Up (PMCF) Studies for Medical Device Manufacturers
While post-market clinical follow-up (PMCF) played a part in the MDD (Directive 93/42/EEC), the updated Medical Device Regulation (MDR, 2017/745) introduced stricter rules for post-market surveillance, including post-market clinical follow-up. The increase in clinical data [...]
Post-Market Surveillance – Responsibilities of Medical Device Manufacturers
Post-market surveillance is a significant part of any medical device manufacturer's responsibilities, especially since the European Medical Device Regulation (MDR, 2017/745) implementation put an extra focus on post-market surveillance and vigilance activities. Today we are [...]
Post-Market Surveillance – Responsibilities of National Regulatory Authorities
We've explored post-market surveillance (PMS) for medical device manufacturers many times, for example, in our articles on post-market surveillance under the MDR, MDR post-market surveillance compared to the IVDR, and the relationships between literature [...]
Post-Market Surveillance and Vigilance: MDR vs IVDR
The Medical Device Regulation 2017/745 (MDR) and the In Vitro Diagnostic Regulation 2017/746 (IVDR) are two sides of the same regulatory coin in almost all aspects: both regulations seek to set up a regulatory system [...]
The Relationships Between Literature Search and CER and PMS Vigilance, PMCF, and PSURs
A systematic review of the literature, including both peer-reviewed and grey literature (e.g., conference abstracts), is recommended as part of a clinical evaluation report or CER and the post-market surveillance of medical devices. The [...]