EU MDR Compliance, Real World Evidence Generation, & Clinical Evaluation Report Writing
Our specialised Real World Evidence (RWE) generation systems and suite of associated services will ensure EU MDR compliance of your medical devices.
Real World Evidence Generation Systems
Real World Evidence (RWE) and higher quality clinical evidence are now required to CE-Mark medical devices. Obtaining Real World Data is difficult and resource-intensive.
We will work with you to design and develop your RWE generation platform and build it to the highest level of legal and regulatory compliance.
Our systems allow data entry across clinical sites, whilst adhering to GDPR and ISO 13485, 14971 & 14155.
MDR Compliance Services for medical devices
We also provide a full suite of services geared towards ensuring your devices are MDR compliant.
An introduction to Real World Evidence for EU MDR Compliance
26th May 2020 marks the end of the transition period from the old Medical Device Directive (MDD) to the new Medical Device Regulations (MDR) 2017/745.
-
Enhanced standards
From 26th May 2020, the MDR will be in full effect and MDR compliance will be mandatory for all EU-based medical device manufacturers. This will require them to meet the enhanced standards of the new legislation.
-
New requirements
The MDR introduces a range of new requirements for drafting technical documentation, as well as mandating a more comprehensive clinical evidence portfolio that supports safety and efficacy for every individual indication.
-
New challenges
Medical device companies are facing new challenges in meeting the requirements for MDR compliance. Claims of equivalence may fail and the need to evidence every indication places huge demands on evidence-generation systems.
Why has the Medical Device Directive (MDD) been replaced?
Although generally robust and relatively permissive of innovation, the MDD was considered to have numerous flaws in enforcing medical device safety, reliability and general product quality, exposed by notorious incidents such as the metal-on-metal hip scandal. Legislators were compelled to implement reform.
The new MDR attempts to reduce the likelihood of future incidents of this nature by tightening the requirements for proving safety and effectiveness of all medical devices, regardless of how long the product has been on the market.
How will the industry be affected?
From an industry perspective, the most important changes are the need to provide evidence "on an ongoing basis" to support every individual indication, in parallel with the reduced capacity to claim equivalence to devices already approved for sale. Read a further detailed summary of the changes.
These changes mean that manufacturers across the industry face a significantly increased evidence-generation burden, meaning a potentially huge increase in cost to meet the demands for medical device compliance. In some cases, this may even challenge the commercial viability of a product.
How can Mantra Systems help you?
We are experts at navigating the requirements for MDR Compliance and will ensure that you have the systems in place to meet the demands of the new legislation. Uniquely, our team of in-house, specially trained medical doctors will bring medical expertise to your evidence generation and technical document requirements.
Obtaining a medical device CE-Mark under MDR requires robust clinical evidence in the form of Real World Evidence (RWE), built from Real World Data (RWD). Generating RWE is difficult and resource-intensive. We will work with you to design and develop your real world evidence generation system to the highest level of legal and regulatory compliance.
If you would like to talk to us about our services, please get in touch.
The importance of Real World Evidence
Real World Evidence (RWE) is clinical evidence obtained from Real World Data (RWD) - observational data generated from real-world use of devices rather than formal clinical trials.
-
Robust systems
Real World Evidence can be challenging to generate. It requires a robust data collection system that is capable of harvesting data on an ongoing basis without introducing bias.
-
User focused
It also requires that data entry systems are sufficiently user-friendly to allow clinicians to enter data as a component of their standard practice.
-
Guided choice
There are multiple ways to generate RWE. Our objective is to ensure that our clients choose the method of real-world evidence generation that is right for them.
Important factors
The choice of real world evidence generation method is driven by a combination of factors. Some of the factors to consider include:
- market sector
- availability of external data sources
- product type
- available company resources
- time and criticality
Poor choices
Unfortunately, medical device manufacturers sometimes choose sub-optimal real world evidence collection methods. A poor choice of real world evidence generation methods can lead to an accumulation of problems over time, as weaknesses of either collection method or the data itself tend to compound as data collection is ongoing.
Manufacturers may also find that compliance of investigators to data collection standards is often far below that required by regulatory frameworks supporting MDR compliance. This is especially the case if insufficient attention is given to the choice of data collection method.
Ultimately, the wrong choice of real world evidence generation method leads to wasted time and money, and a critical problem remaining to be solved.
Existing registries
Some market sectors are extremely fortunate in terms of real world evidence. In some clinical specialities there are already external or nationalised registries that collect data on the performance of multiple products within a sector.
For example, the National Joint Registry in the UK collects real-world data on the performance of orthopaedic joint replacement implants. This is a rich source of real world evidence that companies can access to compile evidence for regulatory submission, and has the advantage of being consecutive, non-selective, and objective (ie administered by an external agent rather than the manufacturer of the product in question).
Other market sectors are not so fortunate. In the absence of such nationalised registries, manufacturers must find other ways to generate real world evidence.
Our Medical Device Regulation services
We specialise in producing Real World Evidence Generation Systems that fulfil all requirements for MDR compliance submissions.
-
Real World Evidence Generation Systems
We will design and deliver Real World Evidence (RWE) Generation Systems in the form of a Medical Device Product Registry that will enable your company to generate RWE in a way that complies fully with all relevant legislative and regulatory obligations including MDR, GDPR, ISO 13485, ISO 14971 and ISO 14155.
-
Clinical Evaluation Report
The CER is an essential component of every medical device regulatory submission. New regulatory obligations imposed by MDR mean it is more challenging to draft technical documentation. We are highly experienced in drafting CERs in accordance with MEDDEV 2.7/1 rev 4 and guarantee your CERs will be fully MDR compliant.
-
Medical Risk Management
The publication of the new risk management standard BS EN ISO 14971:2019 - Application of risk management to medical devices outlines more stringent expectations for the performance of structured risk analysis than ever before.
-
Clinical Evidence Gap Analysis
Ensure that expenditure on expanding your clinical evidence portfolio is targeted to those areas of most critical need. Our clinical expertise will identify important deficiencies in your clinical evidence portfolio and advise how to correct them in the most cost-effective manner possible.
-
Medical Complaints Handling
The effective processing of complaints is a central component of any effective medical device Quality Management System. Complaints are a crucial source of information about the performance of medical devices in real use and we will ensure they are handled to the highest professional standard.
-
Post-Market Surveillance conduct
Our expertise in handling and assessing Medical Complaints, analysing clinical evidence gaps, performing risk analysis and building RWE Generation Systems allows us to be your holistic Post-Market Surveillance System generation partner.
-
Clinical Competitor Analysis
A properly structured analysis of a competitor's clinical evidence portfolio can reveal opportunities for significant competitive advantage and can give indications as to where their products are failing to meet market expectations.
-
Clinical Evidence Application Training
Generating clinical data is expensive and time-consuming. While the primary objective in doing so may be to ensure MDR compliance of your devices, Mantra Systems can ensure that your sales team can effectively use this data to support sales calls.
If you have any enquires about our services, contact our team today.
Why choose Mantra Systems?
Our vision is to provide a superior service incorporating the highest professional standards. To deliver our vision we excel in the following three domains:
-
Agility
- We design robust products tailored to your precise requirements
- We offer a suite of services allowing you to choose exactly what you need
- We are responsive and flexible
-
Value
- We ensure EU MDR compliance at lower cost than in-house development of new systems
- We will deliver in weeks rather than months
- You won't need to recruit and train new staff to meet MDR requirements
-
Quality
- We combine clinical expertise with regulatory experience at startup and multi-national level
- We ensure data security through the strictest quality and legal framework
- We understand the market through direct experience in developing medical devices
Frequently asked questions
We have compiled some of the most asked questions we receive. If there is anything else you'd like to know about what we do, please get in touch.
-
We can work with the majority of medical device manufacturers seeking compliance of their devices in accordance with Regulation (EU) 2017/745, with the exception of dental implants, in-vitro diagnostic devices, orthopaedic devices and devices that exert their primary action through a pharmaceutical agent.
-
No. We will work with you to produce RWE Generation Systems and to support your EU MDR compliance, but we do not conduct research ourselves. We will provide tools for you to conduct your own post-market surveillance. Our range of services are designed to assist you in this matter.
-
Yes. We adhere to the highest standards of professionalism and regard maintaining confidentiality and data security as a cornerstone of our practice. We also comply fully with the requirements of GDPR.
-
Our services are built around a strict quality framework and we only work with clients who share this commitment to quality. Our CEO is a medical doctor with years of experience in the medical device industry and assumes personal responsibility of every project. Our product development process integrates client feedback throughout product production, ensuring a constant focus on your needs.
Our latest article & tweets
The new MDR compliance challenge
Across the industry, medical device companies are facing challenges in meeting the demands of the new Medical Device Regulations (MDR) 2017/745 framework.