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
MEDDEV 2.7.1 Revision 4: Guidelines for Clinical Evaluation
In accordance with the European directive for medical devices 93/42/EEC, ‘manufacturers must provide proof of and document the performance and safety of medical devices in a "clinical evaluation"’. With the breast implant scandal in [...]
Breaking Down EU MDR Implementation for Class 1 Medical Devices
Breaking Down EU MDR Implementation for Class 1 Medical Devices Following the one-year delay in the MDR Date of Application, the Class I medical devices, in the lowest risk class, must also conform to [...]
Your NB’s Clinical Evaluation Assessment Report
An Overview of the Clinical Evaluation Report Also abbreviated as CER, a Clinical Evaluation Report is compulsory for all manufacturers who want to put their medical instruments in the European Union’s market. It is [...]
An Understanding of the Clinical Evaluation Process in China – Comparison with EU MDR
Medical device regulations in China are often similar to the European Union (EU)’s MDR. With a vital prerequisite of Clinical Evaluation Reports (CERs), as required by China’s National Medical Products Administration NMPA (formerly CFDA). [...]
EU IVDR – Part I
The EU IVDR Regulation - An Overview - Part I The PIP breast implant scandal brought to light weaknesses in the overall regulatory process to control IVDs. It may include - The certification system [...]
EU MDR Clinical Evaluation Requirements – Understanding the CER
EU MDR Clinical Evaluation Requirement – Understanding the CER A critical component of the Technical File Submission for the CE Marking /conformity assessment process is that clinical evaluation reports are essential to sell or [...]
Medical Device Literature Search and Review under EU MDR
Systematic Literature Review
In May 2021, the European Medical Device Directive (93/42/EEC) was replaced with the Medical Device Regulation (MDR, 2017/745). Unlike the MDD, the MDR considers clinical evaluation to take place during the full lifecycle of [...]
How to Hire a Literature Search (or CER) Writer and What to Look For?
INTRODUCTION A literature search is a deliberate and efficient search from already distributed information to distinguish between a good quality reference on a particular topic. There are different reasons for conducting a literature search, [...]
Periodic Safety Update Reports: Why You Might Need One Annually
Periodic Safety Update Reports: Why You Might Need One Did you know that the Literature Searches you submit for your CE Marking Clinical Evaluation Report might have to be re-run annually? [...]
Cost Savings of Literature Searches in Your CER
Cost Savings of Literature Searches in Your CER Introduction We recently had a client that wanted to weigh the option of outsourcing their entire CER project overseas to more attractively [...]
Post Market Surveillance for EU MDR
Breaking Down EU MDR Implementation for Class 1 Medical Devices
Breaking Down EU MDR Implementation for Class 1 Medical Devices Following the one-year delay in the MDR Date of Application, the Class I medical devices, in the lowest risk class, must also conform to [...]
Are You Over Committing to Your EU MDR Post Market Surveillance Plan?
Overview The EU MDR and IVDR will usher in increased post-market surveillance (PMS) requirements for all MedTech companies. A PMS plan will incorporate a Post-Market Clinical Follow-up (PMCF) plan or justification for why [...]
Post Market Clinical Follow-Up (PMCF) – Understanding MDCG’s Latest Guidance
Guide - MDCG endorsed documents and other guidance documents. The majority of documents on this site need approval by the Medical Device Coordination Group (MDCG) as per Article 105 of the MDDR and Article [...]
Post Market Surveillance Series – Part 2, Vigilance Reporting
The Post Market Surveillance Series (Part 2) Part 2: Vigilance and Incident Reporting In the second post of our Post Market Surveillance series we’re going to dive into incident reporting [...]
Post Market Surveillance Series – Part 1
The Post Market Surveillance Series (Part 1) Post Market Surveillance in MDR There are only a handful of explicit things that you HAVE to do under MDR for PMS, however [...]