The Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) coupled with Brexit (UKCA marking) have seen companies in the sector struggle to understand the changes and also to resource and ensure that their technical documentation complies.The risk is that devices will be delayed getting to market or if already on the market companies might lose their certification.
Our Services
Since the publication of the MDR (EU 2017/745) and IVDR (EU 2017 / 746) we have developed a gap analysis service that uses a bespoke tool to audit compliance of your Technical File with the MDR. This includes three levels of service in which we provide a bronze level of support covering each element of your technical file during interactive sessions with verbal advice and feedback, through to our full gold service in which we provide an in-depth analysis of the technical documentation and a detailed report identifying gaps and recommendations with regard to how they can be addressed.
We can provide guidance, additional resource, or advice on your documentation, from the design history file that documents all the design and development activities to the technical documentation according to MDR 2017/745/ IVDR 2017/746.
Our training solutions range from introductory training covering the regulatory process (with a focus on UKCA and EU MDR), and types of technical documentation to more detailed courses and workshops covering the design history file, design control and technical file construction (including product labelling, information to be supplied by the manufacturer, design and manufacturing information), the General Safety and Performance Requirements (GSPRs), benefit risk analysis, risk management, clinical evaluation and post market surveillance requirements.
Our courses and workshops are tailored to your individual need and are designed to be interactive in which you benefit from bespoke consultancy during the sessions.
A Clinical Evaluation Report (CER) is a key component of the technical file and is used to support the intended purpose, product claims and to demonstrates that the benefits outweigh the risks.
The CER/ PER is a pivotal part of the technical documentation which is needed to both get a CE mark and also to maintain the product on the market.
The Medilink Team have extensive experience in authoring CERs.
Recent guidelines MDCG 2020-6 provide alternative means to for you to show conformity to the relevant General Safety and Performance Requirements (GSPRs) for legacy devices and might offer an alternative CER strategy to the conventional one described under MDR.
Our service includes:
- A CER strategy workshop which can help determine whether your device qualifies as a legacy device and to determine potential equivalence and similar products you can use. This will also cover the area of selection of products for benchmarking performance and safety.
- Full CER writing service.
Medilink have developed the MediPathTM Innovation Roadmap to help our clients plan their innovation journey to reduce risk, accelerate the speed to market, maximise the probability of market success and enhance profitability.
Drawing on our extensive experience and understanding of best practice, our team of experts have created a new tool to ensure that all key activities and milestones are considered. MediPathTM gives a comprehensive breakdown of all commercial, technical, clinical and regulatory actions, along with the associated resources, costs and time to get a medical device to market. See here for more information.
Testimonials
Let me first take this opportunity to thank you very much for your contributions over the past 2 years or so. Without this, our business unit would not be what it is today. The work you have completed sets a very high standard.
BioMin Technologies commissioned Medilink to author a Clinical Evaluation Report (CER) for a class IIB device technical file submission with a tight deadline and were delighted with both the quality and speed of the report. In fact, it’s the best overview and review of our product I have seen and we will use it for technical, marketing and other purposes. Many thanks to Medilink on a great job.
Medilink authored a development Clinical Evaluation Report and we were delighted with the quality of the work, it was comprehensive, insightful and also provided us with a much deeper understanding of alternative solutions and competitor products. We look forward to working with Medilink again in the future.
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