EU MDR 2017/745 What Changed? – Published April 2022
The new medical device regulation, EU MDR 745/2017, has several additional criteria in regard to previous legislation. This new regulation also has a stronger connection to EN ISO 13485:2016. What modifications are made to the prior medical device regulation, and how must you implement these changes in your current quality management system?
This article contains important information for manufacturers and distributors of medical devices
To retain your certificates, you must understand the changes and know how to implement them. Firstly, knowledge of the interfaces between EN ISO 13485:2016 and the EU MDR 2017/745 is crucial to comprehend and implement the amendments. Furthermore, you need to understand which elements of EU MDR 2017/745 are not covered by EN ISO 13485:2016. Certificates issued under the existing MDD remain valid. Thus, you can place products on the market for a limited period. However, no significant changes can then be made to the products, the quality system, or the company. There can also be no certificate extensions during this time.
Products destined for the UK market must comply with the UK government’s new product marking UKCA. That went into effect on January 1, 2021. The UKCA transition period for medical devices is currently planned to end on June 30, 2023.
Table of contents
- A Bit of History and the Current Actuality
- EU MDR 2017/745 What Changed? Quick Overview of Key Differences
- #1 The Technical Documentation
- #2 Establishment of Compliance with ”General Safety and Performance Requirements”
- #3 Requirement for a ”Person Responsible for Regulatory Compliance”
- #4 New Procedures Concerning Information Databases
- #5 Strengthened Requirements for Post Market Surveillance
- #6 Requirement for ”Summary of Safety and Clinical Performance”
- #7 Changes to the Classification Rules
- #8 Implementation of Unique Device Identifier (UDI)
- New Certification Audit
- EU MDR vs. ISO 13485
- How ISO 13485:2016 Helps With EU MDR Compliance
- EU MDR 2017/745 What Changed? And is ISO 13485 mandatory for MDR?
- EU MDR 2017/745 What Changed and How Does it Impact a QMS Implemented Using the ISO 13485 Requirements?
- EU MDR 2017/745 What Changed? Sources, Links and Downloads
A Bit of History and the Current Actuality
Two new medical device regulations were issued on May 5, 2017, and they took effect on May 25, 2017.
- The Medical Devices Regulation (MDR) has May 26, 2021 as date of application.
- Compliance is required to be permitted to place medical devices on the European market after that date.
- Unless transitional arrangements allow for continuing placement of devices on the market.
- The In Vitro Diagnostic Medical Devices Regulation (IVDR) has May 26, 2022 as date of application.
What is MDR (EU) 2017/745 – Medical Devices Regulation?
1. The Medical Devices Regulation (EU) 2017/745 has taken the place of two previous directives: The MDD (Medical Devices Directive) and the AIMD (Active Implantable Medical Device Directive).2. The IVDR will take the place of the In Vitro Diagnostic Directive (IVDD). Both laws offer lots of significant enhancements to medical device conformity assessment, with the goal of:
- Enhance the quality, safety, and dependability of medical devices sold in Europe.
- Consumers and practitioners should have more access to information on medical devices.
- Increase market supervision and vigilance of devices in use.
EU MDR 2017/745 What Changed and How Will it Affect Your Business?
The impact of these changes on your business will vary. That depends on the sort of product you make and the position you hold (manufacturer, importer, authorized representative). Does your organization aims to achieve compliance with the regulations, then you must expect significant changes to the:
- compliance process;
- quality management system; and
- technical documentation.
As a stakeholder, you need to successfully implement and certify these changes as relevant to the device classes and roles of your organization. It is vital that you become familiar with the new standards’ requirements as soon as possible. So that you can plan for a smooth transition.
EU MDR 2017/745 What Changed? Quick Overview of Key Differences
The revisions to the MDR and IVDR are frequently mistaken as a revision of the requirements. On the contrary, it is actually new legislation that should be treated as such.In general, the current legislation maintains the MDD and IVDD principles and requirements. But in addition to that, there are number of new requirements that manufacturers need to address before an application for certification to the MDR and IVDR can be made.
#1 The Technical Documentation
There is a new structure of the technical file. Also, the level of details from the content of the technical file has changed. The MDR describes in Annex II and III specifically what must be included in any documentation. Previously the MDD specified comparatively little in terms of content, the MDR now tightens up and even goes a step further by specifying criteria for a TD on post-market surveillance.
#2 Establishment of Compliance with ”General Safety and Performance Requirements”
With the implementation of the new EU Medical Device Regulation (MDR 2017/745), the ‘Essential Requirements’ of the MDD and AIMDD will become superseded by the new EU MDR General Safety and Performance Requirements (GSPRs).
#3 Requirement for a ”Person Responsible for Regulatory Compliance”
Under the new regulation, you require a ”Person Responsible for Regulatory Compliance”. He or she must be appointed within the manufacturer (Article 15 of the MDR). It intends to ensure companies have a qualified regulatory expert at their disposal.
#4 New Procedures Concerning Information Databases
New regulations implement new or revised procedures to handle new requirements. This includes entering information into the databases, such as Eudamed.
#5 Strengthened Requirements for Post Market Surveillance
There are strengthened requirements for post market surveillance. Moreover, the requirements for clinical evaluation, post market follow up and clinical investigations (Annex III XIV & XV) are also strengthened. It should be noted that the processes for post market surveillance/post market clinical follow up should implemented as soon as possible. This is because the data generated will be very useful for documenting compliance to the new requirements when you apply for MDR or IVDR.
#6 Requirement for ”Summary of Safety and Clinical Performance”
The Summary of Safety and Clinical Performance (SSCP) is a new requirement under the EU MDR (applicable to Class III and implantable devices). The basic requirements for the SSCP are described in Article 32 of the EU MDR. Further guidance was issued by the Medical Device Coordination Group (MDCG) in August 2019: MDCG 2019-9 Summary of safety and clinical performance – A guide for manufacturers and notified bodies.
Although the MDCG guidance is careful to distinguish between requirements and recommendations it represents current best practice, and regulators will look for conformity with all of its recommendations. This White Paper explains the purpose and contextual background of the SSCP and summarizes the key requirements and recommendations from the MDR and MDCG 2019-9 guidance.
#7 Changes to the Classification Rules
The conformity assessment system, as we know it from the MDD, is generally upheld. Even though there are changes to the classification standards. Some products have been assigned a higher class, necessitating a more rigorous conformity assessment process (for example, some products that used to be IIb are now class III and thus subject to a design examination.) Furthermore, the notified body’s assessment procedure has become more complex, with heightened scrutiny, particularly for class III and IIb implants and infusion devices.
#8 Implementation of Unique Device Identifier (UDI)
One of the new things that come with the new EU MDR 2017/745 and IVDR 2017/746 is the introduction of the UDI. More specifically, it is a Unique Identification Number Europe, as there is also one in the USA. This element will be key for the traceability of devices in Europe.
New Certification Audit
The Notified Body will need to perform a new certification audit of your organization once it has been implemented. The certification procedure begins with a new certification application and closes with a new certificate that is valid for up to 5 years. Assessment of technical files (Class IIa, IIb), evaluation of the design ( Class III ), inspection of the quality system for compliance, and finally an on-site audit where compliance is validated are all part of the certification process. If the manufacturer outsources important tasks or relies on key suppliers, an audit of these parties may be required before the certification procedure is completed and the certificate awarded.
EU MDR vs. ISO 13485
First of all, it is important to note the difference between these two frameworks. In a nutshell, the EU MDR outlines what you must do in order to manufacture medical devices for the European Union market. Whereas the EU MDR only applies to companies who sell medical devices within the EU, ISO 13485 is applicable to any company anywhere in the globe.
MDR EU 2017/745
The EU MDR is a law issued by the European Union that specifies what an organization must do in order to manufacture or import medical devices into the EU. This legislation specifies how medical devices must be labeled and certified. Also, it specifies revisions on what information must be given to the Eudamed database.
EN ISO 13485:2016
On the other hand, ISO 13485, is a globally recognized platform for the development of a quality management system for medical device companies. Any company that demonstrates it develops medical devices and provides related services that consistently meet consumer and regulatory criteria can employ ISO 13485 requirements.
How ISO 13485:2016 Helps With EU MDR Compliance
The EU MDR outlines the minimum requirements that need to be included in a QMS. All of these are also covered in the ISO 13845. The QMS requirements, described in article 10 of the EU MDR, are listed here below. Behind each description you can find the exact clause that covers that specification in the ISO 13485.
- “A strategy for complying with regulation” is also covered in ISO 13485, clause 4.1
- “Safety and performance” is also covered in ISO 13485, clause 7.5
- “Management responsibility” is also covered in ISO 13485, clauses 5.1 and 5.5
- “Resource management” is also covered in ISO 13485, clause 7.4
- “Risk management” is also covered in ISO 13485, clause 7.3
- “Clinical evaluation” is also covered in ISO 13485, clause 7.3
- “Product realization” is also covered in ISO 13485, clause 7
- “Verification of Unique Identity assignment” is also covered in ISO 13485, clauses 7.5.8 and 7.5.9
- “Post-market surveillance system” is also covered in ISO 13485, clauses 8.2.1 and 8.2.2
- “Communication with authorities” is also covered in ISO 13485, clause 8.2.3
- “Incident reporting” is also covered in ISO 13485, clause 8.2.3
- “Corrective and preventive actions” is also covered in ISO 13485, clauses 8.5.2 and 8.5.3
- “Monitoring and measurement, data analysis and product improvement” is also covered in ISO 13485, clause 8.2
EU MDR 2017/745 What Changed? And is ISO 13485 mandatory for MDR?
The short answer is that ISO 13485 certification is not required for EU MDR compliance. However, despite the fact that the EU MDR law does not specifically mention ISO 13485, it does require that you have a QMS in place. The EU has produced a list of harmonized standards to aid firms in understanding all of the standards that apply to medical devices in the EU, and the ISO 13485:2016 standard is the only QMS standard indexed on this list — as a result, most companies utilize ISO 13485 to execute their QMS.
Furthermore, It’s worth noting that the EU MDR regulation isn’t aiming to replace ISO 13485 as a QMS standards document. The EU MDR legislation specifies specific processes for medical devices. Moreover, the ISO 13485 standard is meant to be an all-encompassing set of interrelated regulations that establish internationally recognized best practices for a medical device manufacturer. When you construct your QMS following the ISO 13485 criteria, you can assure that not only do you have an excellent system for your medical devices. But also, you have a system that meets the EU’s authorized QMS standard.
EU MDR 2017/745 What Changed and How Does it Impact a QMS Implemented Using the ISO 13485 Requirements?
Largely, to comply with the EU MDR criteria, more records will be required. For example, ISO 13485 mandates that you keep a medical device file (clause 4.2.3), which must contain a minimum set of data. This documentation, however, will need to include all of the information specified in Annex II of the EU MDR for the medical device technical file in order to comply with EU MDR rules. The EU MDR also necessitates the keeping of additional post-market surveillance and clinical evaluation records. The procedures you use to create, update, and maintain this documentation, on the other hand, will essentially remain unaltered.
Although ISO 13485 is not directly cited in the EU MDR law, it is the only QMS standard listed in the EU list of harmonized standards. This makes it the only reasonable approach to implement a QMS in accordance with the MDR. That is an extra benefit on top of becoming MDR compliant, because ISO 13485 provides a full system dedicated to helping you improve your quality operations.