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

Are you transitioning from the MDD to the MDR or are you developing a new product for the first time? If so, we can provide a gap analysis that will help you determine your regulatory strategy and prioritise areas of focus. This includes an assessment and support in understanding how your device might be classified or reclassified under the new regulations.

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.

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.

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