Clinical Evaluation Center for Devices

Our Parent Concern

Medical Standards

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Medical Standards in Place

There are two main medical standards that guide the medical device manufacturers with the Clinical Investigation and Clinical Evaluation Process. Those medical standards are:

 

MEDDEV 2.7.1 Rev 4 - MEDDEV 2.7.1 Rev.4 is a guidance document that provides guidance for medical device manufacturers and notified bodies who should perform clinical evaluations for medical devices, which fall under 93/42/EEC and 90/385/EEC. 

      

EU MDR 2017/745 - The EU Medical Device Regulation (MDR) will replace the EU's current Medical Device Directive (93/42/EEC) and the EU's Directive on active implantable medical devices (90/385/EEC). The regulation applies to all Medical Device Manufacturers who intend to place their medical devices on the European market. On May 5, 2017, the Official Journal of the European Union has published the EU MDR 2017/745 and on May 25, 2017, it came into force. The main purpose of this MDR is to ensure that the medical devices certified under EU MDR 2017/745 are safe and efficient to use in Europe. 

Clinical Evaluation - Compliance to MDR 2017/745 & MEDDEV 2.7.1 Rev 4

Clinical Evaluation necessities have expanded drastically since the arrival of MEDDEV 2.7.1 Rev 4 in 2016 and the MDR 2017/745 in May of 2017. These standards currently recommend the preparation and submission of two documents namely:

  1. Clinical Evaluation Plan (CEP) and

  2. Clinical Evaluation Report (CER)

Some Notified Bodies expect the Clinical Evaluation documents to be compliant to MEDDEV 2.7.1 Rev 4 as right on time as of January 2017. But MEDDEV is just a guidance document that does not have any legal binding. Therefore, some Notified Bodies have broadened the deadline so that the MEDDEV implementation can match with that of the MDR. All things considered, Notified Bodies will at present hope to see a plan on how the new guidelines and regulations will be executed. Full compliance to both the MEDDEV and MDR is required by May 26, 2020.

How can We Help?

EU MDR 2017/745 Certification is in place now. It is high time to start working on the transitions from MDD to MDR. When compared to MDD, the MDR has more rigorous requirements and assessment procedures. So gap analysis needs time and all documents prepared for MDD earlier have to be reviewed and revised in order to meet regulations of EU MDR 2017/745 Certification. 

In addition to EU MDR 2017/745, we also ensure compliance with MEDDEV 2.7.1 Rev 4, thereby ensuring that clinical investigation and clinical evaluation are performed to the best possible extent. 

We are here to help you achieve compliance with the EU MDR 2017/745 and MEDDEV 2.7.1 Rev 4 by doing a detailed gap analysis, thereby reviewing and revising the entire set of documents including the following:

  • Device classification based on risk-level

  • Technical file prepared for CE marking

  • Clinical Evaluation Report (CER)

  • Risk management file

  • Post-Market Surveillance 

  • Economic Operators Agreement

  • Product life cycle development plan 

So contact us right away and keep yourself ready and up-to-date for the transition from MDD to EU MDR 2017/745. ​​

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Tel. 02-6264-9001

Life officetel 320, 40, 63Ro, 
Youngdeungpo-Gu, Seoul,

07345, Korea

wpark19@gmail.com

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