Regulatory

Introduction

The Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) coupled with Brexit  (IKCA 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.

Medilink have an internal team and an addition specialist team of associates  represents a one stop  shop that can help you with all your regulatory needs.


Gap analysis

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.


Technical file documentation

If you need support, help, addition  resource or simply advice with the your documentation from the design history file to the technical file  we can provide support.


Clinical evaluations report (CER) /Performance Evaluation Reports(PER)

A Clinical Evaluation Reports (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

  1. 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.
  2. Full CER writing service

TESTIMONIALS

“Medilink’s support with Arab, Asia and Africa Health along with FIME has been exceptional. The team’s sterling pre-show planning and onsite support has meant that the meetings were stress free, and highly productive. Both Tom and Melissa are a delight to work with and a credit to Medilink. All of the exhibitions delivered a large number of high-quality leads, most of which have been converted into potential distributors, and or customers.”

Dean C Sleigh

General Manager, Chemviron Carbon

“We have been exhibiting at Medica for almost 25 years. It is the best event for us to meet up with our current customers and distributors, as well as secure new contacts and leads. We easily receive in excess of 100 enquiries, mainly from Europe but further afield too; such as the Middle East. We have been extremely pleased with the continual and invaluable support from the Medilink team, the location and the design of the UK pavilion and we rebooked straight away.

Steve Nixon

Commercial Director, Viamed Ltd.

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