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
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, [...]
When does the Manufacturer HAVE to go for Clinical Investigation?
Medical device manufacturers conduct clinical investigations to ensure that products meet the rules. To most, it is simply a necessity in order to get their medical devices approved. However, in some cases, the clinical [...]
Clinical Evaluation Assessment Report Rubric: What Does It Mean For Your MDR Submissions?
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 [...]
Medical Device Literature Search and Review under EU MDR
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 [...]
MEDDEV 2.7.1 Revision 4: Guidelines for Literature Search
The MEDDEV 2.7.1 is the most important technical guidance document for literature search under the MDR in the medical device regulatory industry. Since the MDCG documents do not currently offer any concrete guidance on [...]
Post Market Surveillance for EU MDR
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 [...]
Building Your PMS Templates
This document intends to cover a comprehensive framework for each of your products. Use it as a guide to direct your staff in the various parts of Post Market Surveillance (PMS) for [...]
Buyers Guide to Post Market Surveillance for EU MDR
No matter how hard you try as medical device manufacturer to make sure your device is safe and efficient, adverse events can still happen. Even the most vigorously tested medical devices have adverse [...]
Post Market Surveillance Under the EU MDR
There are only a handful of explicit things that you MUST do for Post Market Surveillance under the European Medical Device Regulation (MDR 2017/745); however, there are many things you SHOULD be doing to continuously [...]
Effectively Handling Corrective and Preventive Actions (CAPA) Process with EU MDR
The EU MDR emphasizes field safety corrective actions to correct non-conformances of the distributed product, but since these principles are used throughout the quality system, they are not limited to the distributed product alone. Preventive [...]