Clinical evaluation pursuant to MEDDEV 2.7/1 Rev 4
or pursuant to EU Regulation 2017/745 (MDR)
In order to release a medical device on the market it is necessary to prove its safety and performance. To this end, a special document called clinical evaluation must be created. It includes an analysis and assessment of clinical data for a particular device and critically discusses the properties of the device and clinical data as well as its benefits and risks.
We are happy to support you in all questions related to your clinical evaluation:
- Creation of your clinical evaluation in accordance with MEDDEV 2.7/1 rev 4 and its update in line with the MDR requirements as well as all related activities:
- Illustration of the properties and detailed description of the device with reference to the instructions for use
- Reference to and comparison with equivalent devices
- Literature search as well as documentation, illustration and recording thereof
- Assessment and weighting of additional clinical data (post-market surveillance data of the predecessor device or of competitive devices, clinical trial using the product under evaluation, …) to provide clinical evidence
- Detailed benefit-risk assessment
- Review of your existing clinical evaluation in terms of its compliance with the new requirements and with regard to audits by the notified body
- Update of your clinical evaluation
- Final review of the requirement for a clinical trial or other alternatives (e.g. post-market clinical follow-up study after marketing authorisation)
The new MDR: Important Information for Manufacturers of Medical Devices
Until now, clinical evaluations had to meet the requirements of MEDDEV 2.7/1 rev 4. Manufacturers whose products already have a marketing authorization must update their products pursuant to the regulations of the MDR (Regulation (EU) 2017/745) until 26/05/2021. They must also update all clinical evaluations to comply with the regulations of the MDR.
The MDR will bring changes to the medical device classification rules, which might mean that some products will be classified higher than before.
Another novelty: Manufacturers are now under the obligation to introduce a systematic market surveillance as part of their quality management system. Collecting data following release on the market (post-market surveillance) is now mandatory. Furthermore, the clinical evaluation must be updated regularly taking into account these post-market surveillance data.
The clinical evaluation plan (CEP), that was optional under MEDDEV 2.7/1 rev 4, now has to be established.
Post-Market clinical follow-up (PMCF)
Another objective of the clinical evaluation now is to reveal possible knowledge gaps for a product and any possible lack of missing clinical data. Furthermore, it shall include recommendations for post-market clinical follow-up (PMCF). PMCF aim at collecting further clinical data and may include the conduct of PMCF studies.
Develop a strategy and schedule for reaching MDR conformity within your company!
Even though there are a lot of uncertainties with regards to the implementation of the MDR you should start to prepare now. There are several areas were changes must be made during the transition period in order to meet the new regulations.
Are you able to cope with this increased workload on your own? Extensive internal resources, i.e. human as well as material ones, are necessary to reach MDR conformity. Check in a timely manner whether some tasks for reaching MDR conformity should better be outsourced. As highly qualified external providers expect a strong demand until 26 May 2021 shortages might be possible.
How may we help?
The first step should be to get an overview of all the measures you need to take in order to reach MDR conformity. Once you have set up your action plan and started the implementation process you are already aware of any possible shortages you might face. We will gladly provide support in creating your action plan or figuring out possible shortages.
With regards to clinical evaluations our clients can benefit from our special offer. After writing or updating one or two clinical evaluations for you we will be able to guarantee the completion of a fixed quantity of evaluations until Mai 2021. Hence you can benefit from planning security and prove to the notified body that you have implemented strategies to reach MDR conformity. Contact us for more details.
+49 9872 9699027
+49 9872 9699029