What are Medical Devices?
Medical devices are the medical equipment and devices used for in vitro tests. These devices are either used in hospitals by healthcare professionals or directly by a patient. The EU market contains around 500,000 different types of medical devices. All of these devices are used for in-vitro testing. They include various products ranging from items to-be-used at one, such as sticking plasters, pregnancy test kits, and contact lenses to large and sophisticated equipment such as X-ray machines, breast implants, pacemakers, hip replacements, and items used in blood testing.
To regulate these medical devices’ manufacturing and marketing, the European Union adopted two new regulations on 5 April 2017 regarding the medical devices which are:
1. Regulation (EU) 2017/745
The European Parliament and the European Council adopted this regulation on medical devices on 5 April 2017. This regulation made amendments in:
- Directive 2001/82/EC
- Regulation (EC) No 178/2002
- Regulation (EC) No 1223/2009.
It also revoked:
- Council Directives 90/385/EEC
2. Regulation (EU) 2017/746
The European Parliament and the European Council adopted this regulation on in-vitro diagnostic medical devices on 5 April 2017. This regulation revoked:
- Directive 98/79/EC
- Commission Decision 2010/227/EU.
Period for Transitioning into New Regulations
For EU MDR
The transition period for EU MDR was three years after Regulation on medical devices entered into force. This means that the deadline for completion of this transition period was the spring of 2020. However, the Covid-19 pandemic delayed the process, and hence, the new implementation date is now 26 May 2021.
The transition period for EU IVDR after entry into force for the regulation of In-vitro Diagnostic Medical Devices is five years, i.e., the spring of 2022.
Timeline for EU MDR
- The EU MDR application will be parallel to the present medical device directives MDD/93/42/EEC.
- It is expected that after the legislation’s publication, the first designations of Notified Bodies will be finalized approximately within 12 to 18 months.
There are some important changes and introductions made in the EU MDR. A medical device manufacturer looking forward to showing compliance to EU MDR must keep them in mind.
1. The UDI System
The Unique Device Identification (UDI) system is intended to make the identification and traceability of medical devices easy in a distribution chain. Manufacturers must assign a single UDI to each of their products. This UDI shall appear in
- Technical documentation
- The EU declaration of conformity
- The packaging label of the device.
The primary purposes of introducing UDI in the EU MDR are reporting problems, reducing medical errors, and taking action against faulty devices.
European Database for Medical Devices (EUDAMED) is designed to collect and share information among
- The member states
- The EU commission
- Notified Bodies
- Economic Operators.
EUDAMED will also help sponsors present on
- Marketed medical devices
- Conformity assessment processes
- Notified Bodies
- Registered Economic Operators
- Vigilant or adverse events
- Market surveillance
- Clinical investigations.
3. Technical File
EU MDR presents requirements regarding content and regular updates of technical information in a more detailed manner while increasing its emphasis on clinical assessments. Also, there aren’t any differences between Class III Medical Devices (designated as design examination file in MDD) and other classes.
4. Clinical Evaluation
MDR gives additional requirements for any on-going clinical data for a device that has not yet been CE marked. For each device classification, the amount of clinical data necessary is directly proportional to the risks associated with its intended use. Devices classified as high-risk (such as Class III and implantable medical devices) will require more data for approval.
5. Medical Device Software
Rule 11, Chapter VIII of EU MDR has designated Class IIa to the software intended to provide diagnostic purposes or make therapeutic decisions. In particular cases, this software can also be designated to Class IIb or Class III.
Reasons for Bringing Out Changes in EU MDD
The implemented directives were not able to cope with the constantly changing dynamics of the medical device industry. Some Incidents (such as those with breast implants and metal hips) and different interpretations of the same directives showed the loopholes present in their legal framework. It also damaged the patients, consumers, and healthcare professionals’ confidence regarding medical devices’ safety. These and many other causes become the reason to bring out changes.
These new regulations are intended to reduce these problems. They also aim to consolidate the safety of medical devices available in the European market. It is also believed that the new regulations will help in strengthening the EU’s role as a global leader in the field of medical device manufacturing as they ensure the following improvements:
- Advanced level of health and safety protection for EU’s citizens who use these products.
- Free and fair trading of these products throughout the EU.
- Adaptation of EU legislation to significant scientific and technological progress will occur in the medical device manufacturing industry.
Improvements within the New Regulations
Some significant improvements have been introduced within both the regulations, such as:
- Strict ex-ante control of high-risk devices through a new pre-market scrutiny mechanism
- Reinforcement of designation and process criteria
- Addition of specific aesthetic devices
- Introduction of a new classification system for In-vitro diagnostic devices
- Improved transparency with the help of EUDAMED and UDI
- Reinforcement of the rules on clinical evidence
- Reinforcement of post-market surveillance
- Improvement in coordination mechanisms.
Guidance Documents for the New EU MDR
To achieve a better understanding of regulatory changes and implementation methods given in new regulations, the European Commission provided the following documents:
- Implementation of Medical Devices EU-Regulation – Focus on Manufacturer’s obligations
- Implementation Model for Medical Devices Regulation Step by Step Guide
- Fact Sheet for Manufacturers of Medical Devices
- Implementation Model for In-Vitro Diagnostic Medical Devices Regulation: Step by Step Guide
- Fact Sheet for Manufacturers of In-Vitro Diagnostic Medical Devices
- TÜV SÜD Factsheet
- MHRA-MDR – IVDR Guidance.
Looking for EU MDR Compliant Systems?
The implementation date of EU MDR is approaching slowly, and medical device manufacturers of Europe are looking forward to showing compliance with the new requirements. If you are among one of such manufacturers, consider seeking services of TSQ Asia & Middle East. We have been working with the medical device manufacturing industry for a long. We are completely aware of the different requirements of the new Medical Device Regulations. We can help you in achieving the systems compliant to EU MDR. Contact us today by visiting our website at tsqasia.com.