CE Archives | CMS MedTech

EXTENSION OF THE MDR TRANSITIONAL PERIOD AND REMOVAL OF THE ‘SELL OFF’ PERIODS

By cmsmedtech May 31, 2024CE

Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in…

EU Authorised Representative

By cmsmedtech January 13, 2023CE, EC REP

In which cases do you need to assign the EU Authorised Representative for Medical Devices? Read further to know more about this subject. Certification Company – Your reliable EU Authorised Representative…

EU Medical Device Regulations

By cmsmedtech January 13, 2023CE1 Comment

What is EU-MDR compliance? The European Medical Device Regulation (MDR) is a set of regulations that governs the production and distribution of medical devices in Europe, and compliance with the…

Common Specifications

By cmsmedtech November 10, 2020CE, common specifications

CS Links Commission Implementing Regulation (EU) 2020/1207 of 19 August 2020 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as…

How to do Biological Evaluation

By cmsmedtech October 31, 2020biological evaluation, CE, technical documentation

How to do Biological Evaluation (according to ISO 10993-1: 2009) This is how biological evaluation was performed previously: Identify device contact nature Identify contact time Performed test as indicated in…

How to do PMS

By cmsmedtech October 29, 2020CE, pms, technical documentation

How to do PMS (Introduction) Now with the introduction of EU MDR, there are suddenly a ton of new information that you need to be familiarize with to comply to…

Medical Device Registration in Europe

By cmsmedtech October 26, 2020CE

Medical Device registration in Europe or EU (Entire CE Marking process) https://youtu.be/jPcKVR7liMg Please click here the European commission medical device website and for more information on medical device registration in Europe. …

When to implement UDI?

By cmsmedtech October 22, 2020CE, Singapore, udi

When to implement UDI? For CE Eventually all Medical Device entering EU markets under than custom made and performance studies/ investigational devices. Most of the time the question is when…

Class I reusable compliance to EU MDR

By cmsmedtech October 21, 2020CE

Class I reusable compliance to EU MDR: Introduction We should all by now know that class I reusable device is a new category introduced by EU MDR. (click here to…

How to choose a PRRC

By cmsmedtech October 20, 2020CE

How to choose a PRRC (background) To comply with Regulation (EU) 2017/745 (more commonly known as EU MDR), one of the earliest step that the manufacturer should consider is to…

EXTENSION OF THE MDR TRANSITIONAL PERIOD AND REMOVAL OF THE ‘SELL OFF’ PERIODS

EU Authorised Representative

EU Medical Device Regulations

Common Specifications

How to do Biological Evaluation

How to do PMS

Medical Device Registration in Europe

When to implement UDI?

Class I reusable compliance to EU MDR

How to choose a PRRC

EXTENSION OF THE MDR TRANSITIONAL PERIOD AND REMOVAL OF THE ‘SELL OFF’ PERIODS

Medical Device Registration in Thailand

Medical Device Registration Vietnam (updated 2023)

Medical Device Registration in UK

Medical Device Registration in New Zealand