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Welcoming the Medical Device Regulation in 2021

Standards are necessary to keep things going in a flow. And when it comes to something as important as medical devices, which are responsible for ensuring our health and safety, standardization is necessary.

Among the different standardization bodies present today, ISO, BSI, UKAS, and FDA are some of the most important and renowned. EU also has a regulatory body of its own. It is responsible for creating and implementing its standards across all 27 member states.

Recently, there has been quite a commotion around one of the European Union’s standards, the EU MDD or EU Medical Device Directive. The EU MDD came into being in 1992. Till then, it worked efficiently throughout the European continent. But things started to change with the advancement of technology. 

Although EU MDD is a comprehensive standard, it lacks many necessary details of today’s modern age. These details need to be addressed immediately so that medical device companies can make themselves compliant with the modern era.

What was the Basic Purpose of EU MDD?

EU designed the EU MDD to legislate medical device manufacturers all across Europe. It had a set of articles and annexes. These articles and annexes tell the manufacturers about necessary actions which they should take throughout their manufacturing and marketing processes. Manufacturers who failed to show compliance with the EU MDD were not allowed to work inside the EU territory.

This standard also covered those manufacturers who, although they were situated outside the EU territory but marketed their products in it.

Structural Organization of EU MDD:

Number of Articles: 23

Number of Annexes: 12

Number of Pages: 60

The articles of EU MDD covered various areas [e.g., Medical devices and their accessories, post-production, and requirement for PMS (post-market surveillance), etc.]. 

Reasons for Replacing the EU MDD:

The EU MDD could be regarded as a sophisticated standard if the world was still living in the 1990s. But the reality is that a lot has changed in these years, and there was a need to replace this outdated standard with a modern one. Some of the significant deficiencies present in EU MDD regarding medical device manufacturing include:

  • It missed many essential details, such as those regarding Software as Medical Device (SaMD) and Active Implantable Medical Devices (AIMDs).
  • It does not regulate the apps which patients use to monitor their health.

To address these and many other deficiencies, the EU MDR (European Union Medical Device Regulation) came into being.

Comparison of Structural Organization between MDD and MDR:

EU MDD

EU MDR

  • The EU MDD comprises 23 articles.
  • It has 12 annexes.
  • It has 60 pages.
  • EU MDR contains 123 articles.
  • It has 17 annexes.
  • It has over 175 pages.

 

Aside from the structural differences mentioned above, the EU MDR contains important details, such as:

  • It regulates all the medical devices for human use, including SaMDs and AIMDs;
  • It regulates those apps which patients use to monitor their health;
  • It provides the manufacturers to develop a more sophisticated PMS system etc.

Rules and Regulations within MDR:

Since MDR has come into being through a series of extensive updates, it also contains some new rules for medical device manufacturers to follow, such as:

  • To ensure regulatory compliance within an organization, the organization should acquire the services of at least one person (safety manager, for example).
  • Annex XVI of EU MDR is the newly added annex in the standard. It covers items intended for cosmetic purposes as well as products with intended medical purposes.

Regulations Regarding Safety and Health:

EU MDR puts forward a new set of regulations which cover the safety and health factor of the following products:

  • Items that are applied directly to the eye, e.g., colored and non-corrective contact lenses.
  • Those products require surgical insertion in the human body for modification or fixation of body parts, e.g., cosmetic horn implants.
  • Items used for facial or nasal cosmetic purposes, e.g., dermal fillers.
  • Equipment that aids in the reduction of adipose tissue, such as tools used for liposuction and lipolysis.
  • Tattoo, hair removal, skin resurfacing, and other skincare tools emit high-intensity electromagnetic radiation.
  • Equipment that can penetrate the human skull for modifying neuronal activity using electrical currents or electromagnetic fields.

QMS and EU MDR:

To supervise the interaction of all stakeholders forming the supply chain, EU MDR requires manufacturers to develop an efficient Quality Management System. Many organizations in the world claim to provide medical device manufacturers with their supervising services in this regard. But very few among them can deliver what they have promised. And yet, we at Origami are proud to announce ourselves among those few.

Who are we?

We are a cloud-based platform, and we empower our respectable clients to develop enterprise-grade applications, automate processes, and workflows without the need for any code.

Our user-friendly interface enables our clients to customize their dashboards as per their own choice. We are also providing solutions to facilitate interdisciplinary communication. Our top-notch QMS is also one of our major products.

Origami’s QMS; The New Generation of QMS:

Our professional and dedicated team of developers has managed to develop an eQMS, which will enable a medical device manufacturer to carry on their processes efficiently. Origami’s QMS provides full control and an overview of the medical device manufacturers. It enables the employees of those manufacturers to keep an eye on all of the processes, regardless of their location.

You can always trust the credibility of our eQMS, as we have accreditations from:

  • ISO27001
  • EU Annex11 and
  • FDA21 CFR PT11.

With our simple drag-and-drop interface, your company can get rid of hefty paperwork. With our efficient QMS, we will help you get rid of all of those QMS channels working between you and the regulator. With just one click, you will be able to determine the status of your compliance with the regulations.

Attributes of Origami’s QMS:

Simple and user-friendly interface;

Efficiently automated processes;

Traceability 

Well-integrated communication with every stakeholder and much more.

Our QMS Modules Include:

  • Origami Audit Management;
  • Origami CAPA Management;
  • Origami Complaint Management;
  • Origami Document Management;
  • Origami Change Management;
  • Origami OOS Management;
  • Origami Training Management and
  • Supplier Quality Management.

Our clients can always expect our best of us. If you are seeking forward to enjoy our convenient eQMS, feel free to contact us at +972 (0)9 880 1955 or simply email us at [email protected]

Let us demonstrate what our platform can do for you!

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