Standards are explicit statements of expected quality in the performance of an activity. 

In the medical and HealthTech sector, they may take the form of procedures, clinical practice guidelines, treatment protocols, critical paths, algorithms, standard operating procedures, or statements of expected health care outcomes. 

These standards will outline the usage, safety, and security requirements necessary for a product or solution.

MDR Medical Device Regulation 

Regulation (EU) 2017/745 is a regulation of the European Union relating to the clinical investigation and sale of medical devices for human use. It repeals Directive 93/42/EEC, which concerns medical devices, and Directive 90/385/EEC, which concerns active implantable medical devices, on 26 May 2021.

These changes impact everyone involved in the EU MedTech space, so it is important to familiarise yourself with the updates.

Our Hints

-The Medical Device Directive alters and enhances the MDR Regulation

-MDR contains alignments with regulations outside the EU (to make global market delivery easier)

-All Medical devices must be re-certified according to the MDR

-Due to this, high costs should be expected going forward, especially for new devices

-Current Class 1 devices (minor level) will be moved to a higher level

-There are fewer certification service points (expect longer waiting times for results/permissions)

-Trial and error applications will no longer be possible 

-Useability is now required (meaning trials will need to be planned and performed in advance of application)

-Certification preparation should be included in the development processes as early as possible 

-Document meticulously and throughout the process (retroactively trying to find and create the requisite documentation is incredibly difficult)

-Hiring a regulation expert is advised

-Networking and knowledge-sharing with other companies and institutions can be helpful

ISO 13485:2016 

specifies requirements for a quality management system for organisations that provide medical devices and related services. 

The aim is to ensure that these products and services consistently meet customer and applicable regulatory requirements.

Our Hints:

-Adopt “SMART” measurement and continuous improvement

-Foster internal audits 

-Implement the requirements within your existing quality system -using a holistic approach

-Focus on corrective and preventive actions 

-Encourage proactive customer feedback

-Organise management reviews

-Conduct careful risk management

-Start the documentation process at the earliest possible stage of the project

The additional relevant ones IEC and FDA are as well important standards and are explained in another THAUMATEC Knowledge blog post.