Mitigating Risk of Shortages: More Time to Certify Medical Devices – European Commission

certify medical devices
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The European Commission has recently approved a proposal to extend the time it takes to certify medical devices in order to reduce the risk of shortages.

The proposal extends the transition period for adapting to new rules, as required by the Medical Devices Regulation.

The new deadlines are based on the risk class of the medical device and will ensure that patients continue to have access to medical devices.

It will also allow medical devices that have been placed on the market in accordance with the current legal framework and are still available to remain on the market.

To summarise the new proposal;

  • The European Commission is considering new proposals to extend the timelines for transitioning to the Medical Devices Regulation (MDR).
  • In July 2022 MedTech Europe published a report focusing on the delays in the certification of general medical devices and active implantable medical devices and included a plea for a course correction to avoid the likely scenario of thousands of devices otherwise being excluded from the market. 
  • The Commission has shared a formal proposal to give manufacturers until 2027 or 2028, depending on risk classification, to get their devices designated under MDR.
  • The proposal now moves to the European Parliament and Council for adoption.
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Robotic Orthopaedic Surgery: Latest Trends

Human beings are living longer and healthier lives than ever, however sometimes this longevity requires assistance.

In recent years, there has been a surge in the need for orthopaedic procedures, such as hip and knee replacements.

In the United Kingdom, there is currently a waiting list of over 700,000 people who require trauma and orthopaedic surgery. Surgeons and their current techniques and medical devices are struggling to keep up.

However, the field of orthopaedics has always been a hotbed of innovation. Numerous technological advances are shaping the practice. New robotic-assisted surgical devices are being developed and utilised in orthopaedic surgery. All trends point toward more Artificial Intelligence (AI) and augmented reality in the operating room of the future.

In this article, we will take a closer look at robotic surgery and its expected role in shaping orthopaedic surgery in the coming years.

What Is Robotic Surgery?

The thought of a robot carrying out surgery might once have been in the realm of science fiction.

However, robotic surgery is fast becoming common practice and transforming medicine worldwide. More than 600,000 robotic surgeries are performed in the United States every year.

The use of robots in surgery was first put forward by the US department of defence. Authorities were looking for a way to minimise battlefield casualties in the late 1960s. At the time, robots were revolutionising manufacturing, and the applications of the technology seemed endless. Nevertheless, the additional technology needed to make it work took several decades to catch up.

One of the first times it was used in the late 1980s was in a prosthetic hip replacement surgery. Later on, virtual reality and technology to manipulate medical devices came about. In the early 2000s, the first robotic surgical system came on the market. This boosted the field of minimally invasive surgery. There are now dozens of devices targeting different areas and specialities.

There have also been exciting developments using Artificial Intelligence in which surgical robots learn to detect disease and assist in surgery. This can help in planning the operation or allow the surgeon to control the medical device using movements of their eye or head. AI is also allowing some surgical robots to be trained to carry out precise, repetitive tasks. AI can also reduce any trembling in the manipulation of instruments. This can allow for a greater degree of accuracy and improve outcomes for the patient.

For now, robotic surgeries still have the surgeon in the driving seat. They are sitting next to the patient and
running the whole operation. The surgeon inserts 3D cameras into the patient for a magnified view. They then manipulate the machine’s controls.

How Are Robotics Used in Orthopaedics?

Orthopaedic surgery is well suited to robotics because it deals with bones, which are fixed objects with a recognisable position and form. As a result, it is far easier to control robotic procedures on bone than on human tissue. The first use of robotics in orthopaedic surgery was to help surgeons plan and carry out hip replacements in the nineties. Robotic orthopaedics now allows for medical assistance in hip, knee, spine, ankle, and shoulder surgeries. It is particularly useful for joint replacements and joint resurfacing.

Here are some of the main applications of robotics in orthopaedics:

Surgical Planning

Many orthopaedic robotic systems incorporate advanced methods of surgical planning. This can involve using CT scans to create a three-dimensional model to make precise measurements. This can guide the surgeon from start to finish of the operation. Some surgical planning systems also allow for a more personalised approach to the surgery. For example, they can take measurements that allow for a custom-made orthopaedic implant. Some robotic systems eliminate the need for CT scans. They are able to map the surface of the diseased cartilage and bone during the surgery. Analysis of patient-specific data can also provide insights to inform planning and patient care after the surgery.

A lot of the surgical planning feature of robotics uses AI. Gathering thousands of images and data allows surgeons to see what works best in similar scenarios. It also leads to the development of new smart technology. Ever faster processors, camera speeds, and cutting volume in newer surgery robots are also improving patient outcomes.

Robotic Machining of Bone

A major part of any orthopaedic surgery is bone cutting or drilling. A surgeon will do this to produce holes for screws, repair fractures, or shave the bone to perfectly fit an implant. While machining is a common process, it can lead to problems. The heat from machining can damage cells and tissues. Lack of precision can also lead to nerve damage in sensitive areas such as the spine.

Robotic surgeon systems can take precise measurements of bone density to drill or cut bone in a fast and accurate way that limits potential damage to the patient. Some robotic systems will give resistance and an audible warning to stop cutting if the surgeon moves the tool beyond the area laid down in the operation plan. Bone can be cut within a fraction of a millimetre, a kind of precision that a human surgeon could only dream of. The use of robots also means that fewer cuts to the bone is necessary

Optimised Placement of Implants

Whenever a bone or joint is replaced, an orthopaedic surgeon needs to insert the implant that will take over its function. One of the most important roles of robotic surgery is in perfecting the placement of the implant in a hip or knee joint. The artificial joint needs to be perfectly aligned for optimal mobility, movement, stability, and comfort. Each patient is unique, and a robotic system can map out the precise location of the implant to work with the ligaments and muscles. With hip replacements, robotic 3D modelling can simulate the range of motion of a patient’s leg. This can show the surgeon where adjustments are necessary. It can also improve the patient’s ergonomics and lead to less pain and injury in the future.

New Trends in Robotic Orthopaedics

There is no doubt that robotic orthopaedic solutions are here to stay. Technology is developing fast, with exciting new trends on the horizon. It seems as if every orthopaedic device company is getting involved in robot-assisted surgery — rolling out robots to assist surgeons operating on the knee, hip, shoulder or spine.

Two events in recent years especially signalled that robots were coming into their own in the space:

  1. Stryker spent $1.7 billion for Mako Surgical in order to sell robotic systems to aid knee and hip
    replacement surgeries, and;
  2. Medtronic acquired Mazor Robotics for $1.7 billion so that it could expand into the robot-assisted spine surgery space.

In January 2021 DePuy Synthes announced FDA 510(k) clearance for the Velys system, touted as a first-of-its-kind, table-mounted ortho surgery robot with an efficient design capable of integrating into any operating room. Zimmer Biomet became the first company to deliver a comprehensive robotics platform for Knee, Brain and Spine procedures with their Rosa robotic platform.

Point Robotics MedTech Inc. (Point Robotics), a rising leader in the field of minimally invasive orthopaedic surgical robots, has recently received 510(k) clearance from the Food and Drug Administration (FDA) in the United States for its minimally invasive surgical robot POINT™ Kinguide Robotic-Assisted Surgical System. Point Robotics’ approval marks both Taiwan’s very first FDA-cleared surgical robot and the first ever hand-held robot framework equipped with a parallel manipulator for orthopaedic application in the world.

Here are a few areas where innovation is happening fast in the field of orthopaedics.

Augmented Reality

Orthopaedic surgeons are already using Augmented Reality headsets in the operating room. This overlays computer-generated information on top of what the surgeon is seeing. It can provide instructions, real-time patient data, or 3D images to help the surgeon make decisions.

3D Printing Implants

Robotic systems are now installing 3D-printed implants that have been tailored to the specific patient. Each patient has a different bone structure. A personalised implant will fit and move better with the patient’s ligaments and tendons.

Personalised Care

This leads us to one of the most significant benefits of robotic surgery that experts say will shape healthcare in the future: Personalised care. Using sensors and smart implants, the doctor of the future will be able to measure their patient’s range of motion, walking speed, and other metrics post-surgery. This could even be linked to smartphone applications to collect data about a patient’s recovery. This data can be used to gather information and develop new clinical insights. Some applications already allow patients to report back to their surgeons. Technology such as robots and these kinds of sensors and applications will lead to more holistic
patient management. A better understanding of the patient and their environment will lead to better
recovery.

Benefits of Robotic Orthopaedics

Recovering from surgery can be long and painful. Especially when you have replaced a joint or had a surgeon drill into or shave your bone. The minimally invasive surgery offered by robotics leads to smaller wounds that heal faster. The precision involved results in less pain. This means;

  • The patient is less likely to need opioid painkillers.
  • Surgeries are quicker and more effective with fewer complications.
  • A robot is also far less likely to misplace a screw or cut into a crucial nerve.
  • Patients undergoing robotic surgery also experience fewer implant rejections and complications after surgery.

Get Customised Medical Devices Today

The field of robotic orthopaedics is developing fast. These new technologies are making the lives of surgeons easier. They are also improving outcomes for patients. There is no doubt that the quality of medical devices is crucial in any surgery.


AQF medical provides technical foam solutions to medical device companies around the world.
We provide foam packaging for orthopaedic implant solutions, as well as a wide range of other
medical devices.


Contact us today to learn more about our quality products.

Notice to Manufacturers: MDR Requirements

MDCG Position Paper Notice to manufacturers to ensure timely
compliance with MDR requirements

  • In April 2022, 75% of notified bodies indicated that more than 50% of the submitted applications were deemed incomplete.
  • 90% of currently valid AIMDD/MDD certificates will expire in 2023-2024. 
  • From 27 May 2024, medical devices not certified under the MDR will have no access to the EU market.
  • 30 notified bodies are designated under the MDR, managing around 80% of current AIMDD/MDD certificates. 

Please contact Michael O’Brien at michael.obrien@aqf.ie to arrange a meeting to discuss your medical foam requirements.

The article’s source can be viewed here.

Medical Devices Regulation Updates

Medical Devices Regulation Updates

Medical Devices Regulation

Medical Device Regulation (MDR) & In-Vitro Diagnostic Devices Regulation (IVDR)

The EU’s Medical Device Regulation (MDR) 2017/745 and Regulation 2017/746 on In-Vitro Diagnostic Devices (IVDR) were officially published on 5 May 2017 and came into force on 25 May 2017. 

Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and sale of medical devices for human use. 

It repealed Directive 93/42/EEC, legislation for medical devices, and Directive 90/385/EEC, which concerns active implantable medical devices, on 26 May 2021.

Notified Bodies

Challenges

  • One of the biggest challenges for manufacturers implementing the new MDR & IVDR regulations has been the insufficient number of notified bodies that have been designated.
  • While manufacturers have addressed some of the near-term challenges of the new regulations they still face significant uncertainty and a range of issues.
  • One major concern is the fact some Notified Bodies are still in the process of obtaining designation to the new MDR and IVDR.

Risks

  • The danger for device makers is that not enough Notified Bodies will have received the proper designation prior to the expiration of the current CE Mark certifications for device manufacturers. Medical devices are defined by the Medical Devices Directive (MDD), Active Implantable Medical Devices Directive (AIMDD), and In Vitro Diagnostic Medical Devices Directive (IVDD).
  • If this occurs then the affected manufacturers and their respective devices will no longer be able to be legally marketed in the EU, potentially causing supply shortages for healthcare providers and patients.

Database

  • The NANDO (New Approach Notified and Designated Organisations) database provides information on notified bodies responsible for assessing the conformity of goods which are placed on the market in the EU.
  • At the end of June 2022 there are a total of 30 Notified bodies who have obtained designation under the new MDR and IVDR. The list of Notified Bodies can be found via the following link; NANDO list June 2022

Why Were New Regulations Required?

The Medical Device Regulations 2017/745 are focused on improving patient safety. The objective is to make use of the existing experience with previously sold devices as well as carry out a comprehensive device assessment before and after distribution on the EU single market.

Weaknesses of the previous Medical Device Directive (MDD)

  • The lack of follow-up post-market approval and the requirement for continuous clinical assessment were not mandatory.
  • The inability to keep pace with technology development particularly as it relates to hybrid devices and medical software was also a concern.
  • MDD was based on directives as opposed to regulations.

This resulted in conflict between the directive and the laws of individual countries. This led to inconsistency in how MDD was implemented across the various EU member states.

Notified Bodies

  • Under MDD the focus of Notified Bodies was initial premarket assessments and subsequent approvals.
  • This led to Notified Bodies being perceived as partners to the industry rather than being the gatekeepers for safety and quality.

With MDR liability for failures of devices now transcends not only the original manufacturer but also other companies in the supply chain and distribution network.

MDR Content Overview

  • Is four times larger than the previous MDD.
  • Gives greater attention to device safety with the word safety appearing 290 times in the MDR, but only 40 times in the MDD.
  • MDR has forced device manufacturers to significantly update clinical data, compile pre and post-market surveillance, strengthen technical documentation, and revise labelling for all devices.

The emphasis previously fell on pre-marketing efforts and clearances under MDD and IVDD. The MDR focuses on a life-cycle approach to devices and includes standards for Unique Device Identification (UDI), Post-Market Surveillance (PMS) reporting, and thorough clinical evaluation prior to market introduction.

This encourages a life-cycle approach to medical device regulation and is more in line with the strategy used by the US FDA.

MDR & MDD Regulation

Demographics

The European Union region has a population of approximately 450 million people, and its residents are living longer than previous generations. This creates new issues for medical device companies and regulators as they assess the risks associated with adverse events and failures.

This is one of the major reasons the new regulations put greater emphasis on the product life-cycle than just getting a device to market.

Timelines

May 26 2021: MDR repealed Directive 93/42/EEC, which covers medical devices, and Directive 90/385/EEC, which relates to active implantable medical devices. The MDR originally allowed for a transition period of three years however due to the global outbreak of Covid-19 the full implementation of the MDR was extended and came into force on 26 May 2021. Regulation 2017/746 (EU IVDR) on In-Vitro Diagnostic Devices (IVDR) was agreed upon and entered into force in May 2017 and had a staggering transitional period.

28 January 2022: Regulation (EU) 2022/112 amended Regulation (EU) 2017/746 and facilitated longer transitional periods regarding the validity of certificates issued by notified bodies. Regulation (EU) 2022/112 also allows manufacturers to market and put into service in-vitro diagnostic medical devices that were lawfully placed on the market pursuant to the same IVDD. Safety and performance requirements set out in the IVDR and their respective application date of 26 May 2022 remain unchanged.

26 May 2022: The IVDR became fully applicable, after a five-year transition period. The following links allow you to download the Medical Device Regulation MDR and the In-Vitro Diagnostic Regulation IVDR.

Medical Devices Regulation Timelines

Medical Device Classification

Under MDR the classification of medical devices is a risk-based system which considers the potential risks associated with the devices while also assessing the vulnerability of the human body. Utilising this approach different criteria can be used or combined in various ways in order to determine classification. For example, the degree of;

  • Invasiveness
  • Potential toxicity
  • Length of time the device is in contact with the body
  • Part of the body affected by the use of the device
  • If the device requires energy as part of its operation.

 

In addition, the MDR also sets out special rules for certain devices such as;

  • Contraceptives
  • Substance-based devices
  • Devices that contain nanoparticles
  • Those which contain a medicinal product

Using these criteria an extensive range of different medical devices can then be assessed and classification determined. These are referred to as the ‘classification rules’ and are set out in Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR).

MDCG 2021-24

  • The release of MDCG 2021-24 by the Medical Device Coordination Group (MDCG) had significant implications for manufacturers of specific devices such as spinal implants.
  • The device industry expected the majority of spinal implants that do not preserve motion to be classified as Class IIb. However, the MDCG guidance categorised all fusion devices, motion-preserving implants, as well as components such as hooks and other devices placed in the disc space as Class III.

What does this mean?

  • For device manufacturers, this means a more intense application process, closer scrutiny from notified bodies, and a significant resource investment into reclassification.

Regulation 2017/746 (EU IVDR)

  • Has many common aspects and requirements with the Medical Device Regulations 2017/745.
  • This has resulted in important changes and requirements for IVD manufacturers.
  • The IVDR introduces a rules-based classification system for IVDs which utilises four different classes based on risk from class A (low) to class D (high).

Changes in Risk Classification:

In Vitro Diagnostic Medical Devices
  • A significant change for IVD manufacturers is the change in risk classification.
  • With the implementation of the IVDR, 84% of the in-vitro diagnostics currently marketed in the EU will see a change in classification and require Notified Body certification.
  • This will result in a 12-fold increase in in-vitro devices requiring certification compared to the previous IVDD.
  • The IVD manufacturers will be significantly impacted since they will need to do a gap analysis to ascertain which devices should be placed in a different class, how this will affect conformity assessment processes, and whether more clinical evidence is required.

Introduction to the new Basic UDI-DI system

Before placing a device on the market, the manufacturer has to assign a Basic UDI-DI to the device and input it into the UDI and Device Registration module of EUDAMED.

To allow manufacturers time to transition to the new system, the new Regulations allow for products to be placed on the market after the general application dates of the new Regulations (and until 26 May 2024 at the latest) by virtue of valid Directive certificates. These legacy devices are not subject to UDI obligations but they should be registered in the EUDAMED database.

The Basic UDI-DI is an EU approach for linking devices to their regulatory documentation and it is intended to uniquely identify the product model throughout the entire life cycle of the product. The implementation of the new UDI system will;

  • Enable easier traceability of medical devices.
  • Significantly improve the effectiveness of the post-market surveillance activities for devices.
  • Allow for enhanced scrutiny by competent authorities.

The use of UDI aims to minimise the risk of medical errors and prevent the marketing of falsified devices. Other benefits of UDI include;

  • Improved procurement
  • Waste disposal policies
  • Greater stock control by health organisations and other economic players.

The new UDI requirements will apply to all medical devices except custom-made devices and investigative devices.

Transitioning from MDD/AIMDD to MDR/IVDR

Under MDR/IVDR, a device manufacturer’s quality management system and related obligations under Article 120(3) MDR allows for devices to be placed on the market or put into service until 26 May 2024 provided they are covered by valid certificates under the MDD/AIMDD.

This is dependent on manufacturers continuing to comply with either of those Directives and that there are no significant changes in the design and intended purpose of the device.

While continuing to maintain the quality management system approved under MDD/AIMDD, in accordance with the first subparagraph of Article 120(3) MDR, device manufacturers must ensure all relevant requirements set out in Chapter VII MDR relating to;

  • Post-market surveillance market surveillance vigilance, registration of economic operators, and;
  • Of devices that apply in place of the corresponding requirements in those Directives.

According to Article 120(3) MDR, the notified body’s activities in principle should be a continuation of the previous surveillance activities under the Directives, as notified bodies designated under the MDD or the AIMDD are not designated to conduct assessments under Article 52 of MDR.

In the framework of their surveillance activities, notified bodies need to consider the new requirements resulting from the transitional provisions

CONFORMITY ASSESSMENT TUV SUD

About Medical Devices

The term ‘Medical Device‘ represents all products that are marketed for use in;

  • Diagnosing illnesses
  • Preventing illnesses
  • Monitoring illnesses
  • Treating illnesses

Medical Devices also deliver their principal intended action by physical means. Medical devices cover a wide range of products and include many thousands of devices used each day by healthcare organisations and patient end-users.

Devices include;

  • Pacemakers
  • Defibrillators
  • Orthopaedic implants
  • Heart valves
  • Dialysis machines
  • Wound care products
  • Blood glucose monitors

Under MDR manufacturers of devices of drug-device combination and who are marketing these combination products as a “medicinal product” are compelled to seek a Notified Body Opinion (NBOp).

There is an ever-growing number of drug-device combination products being placed on the market which require NBOp. These include;

  • Drug-eluting stents
  • Autoinjectors
  • Pre-filled nebulisers
  • Pre-filled pens
  • Inhalers
  • Prefilled syringes
  • Transdermal patches

Similar rules apply to combination products under IVDR. The regulatory environment will change as a result of companion diagnostics becoming under the IVDR’s purview.

Companion diagnostics will be subject to a high level of clinical surveillance because they fall within the new IVDR classification’s second risk category, class C. This is especially true for pharmaceutical companies that create their own companion diagnostics.

Types of Medical Devices outlined in the legislation

  • General medical devices
  • Active implantable medical devices
  • In-vitro diagnostic medical device

According to MDR Article 51, devices are divided into the following classes I, IIa, IIb and III, considering the intended purpose of the devices and their inherent risks.

Under MDR a manufacturer must conduct a conformity assessment. This is the process where a manufacturer must demonstrate the requirements of the MDR relating to a device have been fulfilled. Demonstrating conformity is in the first instance the responsibility of the manufacturer.

For the majority of device classifications, the conformity is assessed by a notified body. The higher risk and classification of the device, then the greater the involvement of a notified body in conformity assessment.

A manufacturer must ensure, regardless of the classification of the device, that the general safety and performance requirements are satisfied under MDR Article 5, MDR Annex I.

This includes carrying out the necessary clinical evaluations (MDR Article 5 (3), MDR Article 61, MDR Annex XIV.

For implantable devices and class III devices, a premarket clinical investigation is compulsory, with some exceptions such as modifications of an existing device, demonstrated equivalence to CE-marked device, placed on the market under Directive 90/385/EEC or Directive 93/42/EEC for which sufficient clinical data is already available, and specific exemptions laid down in Article 61(6)(b).

Conclusion

The European MDR is a taste of how the regulatory environment for medical devices will be changing over the next decade.

The newly published ISO 13485:2016 and the MDSAP Program are already pushing for greater standardization and stronger post-market surveillance requirements, along with process-oriented risk management and a life-cycle approach to device management.

If you could like to discuss medical device regulations, please contact AQF today.

New Sterilisation Methods

New sterilisation methods

New sterilisation methods

are being developed to address concerns by the EPA and FDA surrounding EtO sterilization. De Lama has developed its HyPerPure® technology, which leverages hydrogen peroxide, but has coupled it with a unique process and equipment to enable it to be used for a broader spectrum of products. This low-temperature sterilisation process can be used for a number of medical devices that were not previously able to be treated with hydrogen peroxide. 

Please contact Michael O’Brien at michael.obrien@aqf.ie to arrange a meeting to discuss your medical foam requirements.

New sterilisation methods

Medical Device Regulation (MDR) guidance update

Medical Device Regulation (MDR) guidance

Medical Device Regulation (MDR) guidance

The European Commission’s Medical Device Coordination Group (MDCG) has updated Medical Device Regulation (MDR) guidance aimed at manufacturers and notified bodies that work with implantable and Class III devices.

The main purpose of this document is to provide guidance on the presentation, content and validation of the SSCP. The link to the article can be found here.

Please contact Michael O’Brien at michael.obrien@aqf.ie to arrange a meeting to discuss your medical foam requirements.