EU MDR: Medical Device Regulations

Description

Learn important EU MDR compliance requirements detailed in the EU MDR – European Union Medical Device Regulation (2017/745) and In Vitro Diagnostic Medical Devices Regulation (2017/746) in our fully-online Certificate GMP course.

• The EU MDR and EU IVDR are now in force.
• Only minor transitional periods remain for certain IVDR products, in order to avoid medical device supply chain disruptions.

Manufacturers of all medical device types are expected to comply with the EU MDR.

EU MDR & EU IVDR – Regulatory Compliance Requirements

• Most transitional periods for adopting regulatory guidance in the new EU MDR & EU IVDR have now ended (including delays due to the impact of the pandemic on medical device supply chains)
• Manufacturers for medical devices being manufactured, imported or distributed in the European Union are expected to be in full compliance with the EU Medical Device Regulations (EU MDR) and In Vitro Diagnostic Medical Device Regulations (IVDR), which replaced earlier directives for medical devices and in vitro diagnostic medical devices
  

  

The EU MDR & IVDR now apply to all types of medical devices in all product classes, including medical software.

EU MDR versus earlier directives (MDD, AIMD, and IVDD)

What changed from the MDD, AIMD, and IVDD (EU Medical Device Directives) to the requirements in the EU MDR?

In general, the following changes were implemented in the new regulations in the European Union (EU) that are now in full effect.

• The EU MDR (Regulation 2017/745) represents a significant expansion from earlier medical device directives
• There are now over 23 “General Safety & Performance” requirements (refer to EU MDR, Annex I and related Annexes)
• Many products were reclassified into higher-risk categories that require:
  • The involvement of a Notified Body (NB) for Conformity Assessments for Conformity Certificates/CE marks
  • The involvement of expert panels for assessments of technical documents & clinical evaluations for high-risk products 
  • More robust clinical evidence and assessments of clinical evaluations, continuing across the product’s life cycle
• The expansion of the EUDAMED database is ongoing, and in a few years, it will be a requirement for Manufacturers to enter their product data and UDI assignments into EUDAMED (including the Basic UDI, UDI-DIs, and UDI-PIs)  

You’ll learn more about EU regulatory changes in this cGMP eLearning course, covering the updated EU MDRs. This course generally takes from 2  to 4 hours to complete to gain your Course Certificate.

What should Manufacturers, Importers and Authorised Representatives understand about the EU MDR?

• The overall focus of the EU MDR is on ensuring more robust risk-management activities related to:
  • Clinical Evaluation requirements (Clinical Evaluation reporting requirements)
  • Additional post-marketing surveillance responsibilities
  • Quality Management System (QMS) requirements (generally aligned with ISO 13485)
  • Risk Management Requirements (generally aligned with ISO 14971)
  • Joint liability for product defects (the manufacturer is not solely liable, and Authorised Representatives are jointly liable)

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This course helps EU medical device manufacturers, importers, and other supply chain stakeholders understand their responsibilities and liabilities for medical device product safety and performance.

EU MDR course: cGMP eLearning benefits

• In general, cGMP & EU MDR compliance training course will introduce and reinforce regulatory compliance knowledge.
• It will help cGMP industry personnel understand what’s expected during a compliance Audit referring to the updated EU MDR (Medical Device Regulations) and related guidance
• However, you must still read and understand the relevant regulations, and make required adjustments to your business activities to ensure compliance.

A risk-based approach must be maintained across the entire life cycle of the medical device.

Quality Risk Management

Quality Risk management must be implemented across the entire life cycle of a medical device. Risk management activities, discussed in the EU MDR cGMP training presentation, must continue across the entire life cycle of a medical device or in vitro diagnostic product (IVD), in order to ensure product safety and performance.

This includes production and post-production monitoring of product safety information and updating EUDAMED (the European Union’s Database/Databank for Medical Devices).

Understand what Regulatory Authorities expect for EU MDR audits

By completing this EU MDR certificate training course, you will gain insight into what Regulatory Authorities expect in terms of the application of risk management principles to medical devices, across the life cycle of a medical device, including for IVDs and medical software.

EU MDR Course Agenda

This Certificate Training Course introduces key elements of EU MDR & EU IVDR compliance requirements. Topics include:

• What is EUDAMED and how is it used?
• What is the NANDO database used for?
• EU Notified Bodies (NBs) vs UK Notified Bodies
• Increased monitoring of NBs by Government Authorities to ensure product safety & performance
• What new product risk classifications (reclassifications in the EU MDR) mean regarding greater involvement of Notified Bodies (NBs)
• Annex I – General Safety & Performance Requirements (overview of key concepts)
• Person Responsible for Regulatory Compliance (PRRC)
• Stronger focus on Quality Management Systems (QMS) and risk management principles for product safety/patient safety
• EU UDI system – Differences in the EU’s UDI system compared to other countries such as the USA (FDA), TGA etc.
• Responsibilities of key players in the medical device supply chain
• Legal liability for product safety and EU MDR compliance
• Conformity Assessment routes and processes
• CE marks/CE marking
• Preparing for a Conformity Assessment
• EU MDR training resources for manufacturers
• Ongoing medical device safety monitoring (post-market surveillance requirements)

EU MDR – cGMP Course Certificate

Overview of the benefits of completing this EU MDR (cGMP) certificate eLearning course. 

• This training course helps you understand key elements of complying with the EU MDR & EU IVDR (medical device regulations)
• It is suitable for a global audience
• It is recommended for any person, team leader, Quality Manager/Regulatory Affairs team member, importer, and/or Authorised Representative that works in a medical device manufacturing or importing capacity
• It’s available in a self-paced, online format (24/7); you can start your Certificate GMP training course(s) immediately upon ordering online (prices are in US dollars)
• Understanding key elements of EU MDR compliance will help your team develop a regulatory compliance culture
• Once you pass the Final Assessment, a Certificate of Completion is available to download/print for your personnel file, training record file and/or to attach to your resume or medical device industry job application

cGMP eLearning

Recommended blended learning 

cGMP eLearning courses, including this EU MDR presentation, are best combined with ongoing:

• Onsite training
• Product-specific training
• Supervision
• Mentoring

FAQ: Does your medical software product need to comply with the EU MDR?

• If your product is being used in the European Union, it is likely your software needs to comply fully with the EU MDR and IVDR (EU medical device Regulations 2017/745 & 2017/746, respectively).

Here’s a resource for finding out if your software must comply with the EU MDR/IVDR requirements:

Source: European Commission (EC): Is your software a medical device?

Learn more about medical software regulations in the SaMD (Software as a Medical Device) compliance course, suitable for a general global audience.

cGMP Education Purposes Only

Online GMP courses are for education purposes only.

• This online EU MDR compliance training course is for cGMP education and training purposes only.
• Such information is never to be used for operational decision-making.
• You will still need to read and understand the EU MDR and EU IVDD in detail.

Learners will still need to read, understand, and comply with the EU’s medical device regulations (MDR) & in vitro medical device regulations (IVDR) as applicable to their product and distribution regions.

However, the benefits of training include information relating to auditing expectations and EU regulations for medical device manufacturers.

• Focus primarily on key features and new regulatory expectations
• Define key terms and overall regulatory compliance expectations, but does not contain details for each and every Annex or Chapter of the EU MDR
• Highlight key requirements for compliance but do not include full details of the Chapters, Annexes, and Articles as these comprise 175 pages and are generally best when read and understood directly after completing this training course
• Many individuals do best by following the sequence below:
  • Reading the EU MDR regulations
  • Taking the online training course including the online Assessment for the EU MDR course Certificate of Completion *(which helps learners understand the key elements or nuances of the medical device regulations)
  • Then re-reading the regulations again, as often as necessary, to gain a thorough understanding of the requirements
  • Completing the required courses for QMS and risk management (ISO 13475 and ISO 14971)
  • Creating a checklist for compliance with the EU MDR & EU IVDR requirements
  • Following the regulatory requirements and documenting all related activities including compiling the technical dossier and continuing clinical evaluations across the product’s life cycle (via post-market surveillance activities)

Did you know…the updated EU MDR now comprises 175 pages?

It may be best to read/review the EU MDR and EU IVDR, then complete this self-paced EU MDR training course (online); then reread the regulations several times again.

You can download the EU MDR and EU IVDR from the European Commission’s (EU MDR) website.

• Regulatory training reinforces a compliance culture and reminds employees of essential QMS requirements and recordkeeping requirements
• Regulatory compliance courses are not intended to replace onsite, product-specific training and must never be used for decision-making purposes
• Learners should thus also be trained to follow all relevant accepted standards (e.g. ISO standards) & GMP compliance requirements relevant to their medical devices according to:
  • Their medical device classification (risk class)
  • Their distribution regions/jurisdictions
  • Their roles and responsibilities

EU Medical device regulations and guidance

Download the PDF of the EU MDR (Regulation 2017/745).

Review other online training courses for the Medical Device manufacturing industry.

Earn your GMP training certificate in “EU MDR & IVDR ” to add to other GMP education topics including deviations management, complaints management, and CAPA system requirements!

Pre-requisites for EU MDR training

• There are no formal pre-requisites for this course.
• However, it would be beneficial for you to complete the following two training courses prior to completing the EU MDR risk management course so that you understand globally accepted standards relevant to the Medical Device Sector/Industry.
• These medical industry standards include but are not limited to:
  • ISO 13485 QMS – Regulatory compliance guidance training course
  • ISO 14971 Risk Management for Medical Devices

Note: You can purchase several courses in a discounted training bundle – (consider combining 4 or more courses in a training bundle — up to 20 courses — to save on your GMP regulatory compliance education expenses).

Other relevant courses include:

• Complaints Management course
• Deviations and Non-Conformances management course,
• CAPA systems training course
• Data Integrity training course

 

GMP industry compliance training experts

• This is one of our many GMP education topics eLearning courses available 24/7.
• It is a follow-up course to medical-device relevant ISO standards training course(s) listed previously on this page.
• Click here for a list of face-to-face courses delivered via Zoom (onsite training of large groups of personnel may also be available, where feasible).

Explore the online GMP special training bundles (combined training packages).

Purchase a single cGMP training course or purchase a few of the courses you need, via a custom training bundle.

• Note: one learner, one cGMP course completion Certificate per course purchase.
• Learners will have 12 months’ access to the course.
• Learners will gain a downloadable Certificate of Completion for this education topic upon successful completion of the online assessment for this cGMP education topic.

cGMP Training Program Solutions

Do you need to train your personnel to comply with PIC/S GMP regulations and other regulations such as from the FDA, TGA, EC/EMA, UK MHRA, etc?

• If you need to train large numbers of employees (e.g. 50 to 1000 employees, or more), contact us for a custom quote for eLearning or onsite training.
• You can alternatively order discounted GMP education topics/GMP training bundles.
• If you’re purchasing this course for yourself and your future career in the pharmaceutical industry, consider the customisable 4-bundle course packages.

Note: All course prices are in US dollars.

Conversion example: $35 USD = approximately $55 AUD, but can vary slightly depending on changes to the US/AUD exchange rate.

Bundled training options let you ‘mix and match’ standard GMP compliance training courses and/or assign courses to different employees when required (enabling ‘just in time’ GMP training).

All successfully completed courses provide learners with a time-dated GMP Training Certificate for successful completion of that particular GMP education topic.

Review other top-ranked GMP courses and best-practice GMP training courses.

How to order this course.

• Add the course to your basket and complete your purchase.
• Remember, the course fees are listed in US Dollars.
• Check your emails (all folders) for log-in instructions approximately 5 to 10 minutes after your order is finalised.
• Be sure to search for/add the following domains to your safe sender’s list: “@onlinegmptraining.com” and @pharmout.net”.

 

• This EU MDR GMP education course is available fully online (24/7 access).
• One learner (user) per licence.

cGMP Certificates of Completion

• Completion of any of our online GMP courses will enable you to print your GMP topic Course Certificate.
• Certain topics allow you to earn a Credly badge for your social media channels including LinkedIn.
• You can attach your Certificate of Completion to your CV when applying for jobs in the pharmaceutical sector or when asking for a role change/career promotion.