A Complete Guide to Medical Device Certification and Compliance in the European Union and the United

In the European Union and the United Kingdom, there are specific regulatory and legal perimeters that apply to the manufacturing and distribution of medical devices. We have developed this comprehensive guide to assist manufacturers who are either based in these regions or who plan to sell their medical device products on either of these markets.

The global medical device market size was USD 432.23 billion in 2020. Although the global impact of COVID-19 has witnessed medical devices receiving a negative impact on the adoption rate across all regions, the growing prevalence of chronic diseases and the increased emphasis of healthcare agencies towards diagnosis and treatment has fuelled the demand for increased supply of medical device products in the coming years.

This is further augmented by increased investments by leading market players in research and development surrounding the development of technologically advanced equipment, with an aim to cater to the growing demand for innovative devices. Fortune Business Insights says that the global market is projected to reach USD 657.98 billion by 2028.

Introduction to the Medical Device Industry

A Brief History of the Medical Device Industry

A medical device is any device intended to be used for medical purposes. Discovery of what would be considered a medical device by modern standards dates as far back as 7000 BC in Balochistan, where Neolithic dentists used flint-tipped drills and bowstrings. Studies of Roman medical literature also indicate that many types of medical devices were in use during the time of ancient Rome. In the United States, it wasn’t until the Federal Food, Drug, and Cosmetic Act (FD&C Act) in 1938 that medical devices were regulated. Later in 1976, the Medical Device Amendments to the FD&C Act established medical device regulation and oversight as we know it today in the United States. Medical device regulation in Europe as we know it today came into effect in 1993 by what is collectively known as the Medical Device Directive (MDD). On May 26, 2017, the Medical Device Regulation (MDR) replaced the MDD.

Key Players in the Current Landscape

According to a report conducted by Fortune Business Insights at the end of 2020, “the global market is fragmented, with players like Medtronic, Johnson & Johnson Services Inc., Abbott (and) Stryker accounting for a major share in 2020.” The company’s that were profiled focused on strategies such as acquisitions, collaborations, and new product developments in order to strengthen their global market position. The company’s who were determined are listed as follows:

• Medtronic (Dublin, Ireland)

• Stryker (Kalamazoo, United States)

• Fresenius SE & Co, KGaA (Bad Homburg, Germany)

• Koninklijke Philips N.V. (Amsterdam, Netherlands)

• F. Hoffmann-La Roche Ltd (Basel, Switzerland)

• General Electric Company (Chicago, United States)

• Siemens Healthineers AG (Munich, Germany)

• BD (Franklin Lakes, United States)

• Boston Scientific Corporation (Marlborough, United States)

• Johnson & Johnson Services, Inc. (New Brunswick, United States)

What Products Fall Under the Medical Device Category?

Generally speaking, medical products can fall into three categories, depending on the level of risk they possess in terms of widespread use and distribution. These classes range from simple, low-risk devices such as medical thermometers, disposable gloves, or tongue depressors, to high-risk devices that are implanted to sustain life; for example, a pacemaker.

Introduction to Medical Devices and Compliance

The Importance of Safety in the Medical Device Industry

Medical devices can save lives. It is therefore imperative that compliance is adhered to, in order to ensure optimal safety and decrease the level of risk surrounding the product. Patients expect medical devices to be safe, and the main objective of developing a medical device is to help patients and their health. Medical device failures can have adverse consequences not only for the manufacturer but for patients and healthcare professionals as well. For example, American MedTech company Edwards Lifesciences developed several clinical platform devices used to monitor patient blood pressure and pulse during and after surgery. In March 2019, the firm informed users of an issue affecting 11,000 of those devices in the USA after reports that fluids leaking into the AC power outlet could result in an electrical short circuit and cause the device to either stop working or catch fire. This, in turn, could result in serious injuries to patients and healthcare professionals.

What is the Role of Medical Regulatory Compliance?

Medical regulatory compliance ensures that any medical device placed on the market adheres to the correct standards that will increase the level of safety provided to patients and consumers. Essentially, ensuring that the device meets regulatory compliance standards not only enhances customer and investor confidence but also eliminates risks and saves costs in the future. Each region globally has legislation and regulations that must be adhered to before placing any product on the market; however, medical devices usually have some of the most stringent requirements. It is imperative that any medical device manufacturer ensures that the products being distributed are safe and adhere to these requirements.

Certification of Medical Devices in Europe

What Are the Certification Requirements for Medical Products in Europe?

In the European Union, the rules that relate to the safety and performance of medical devices were harmonised in the 1990s. The New Approach was defined in May 1985 in a European Council Resolution in order to represent an innovative way of technical harmonisation. This was done in order to remove technical barriers to trade to help facilitate the free movement of goods inside the EU.

The government of each Member State must appoint a competent authority responsible for medical devices. The competent authority (CA) is a body with the authority to act on behalf of the member state to ensure that the member state government transposes requirements of medical device directives into national law and applies them. The CA reports to the minister of health in the member state. The CA in one Member State has no jurisdiction in any other member state, but exchanges information and tries to reach common positions.

First and foremost, it is mandatory that any medical device being sold in the European Union bears the CE Mark. This certification verifies that a device meets all regulatory requirements of the Medical Device Directive (MDD), or Active Implantable Medical Device Directive (AIMD) as they apply to the product. These are the steps to the CE medical device approval:

1. Ensure that the product is compliant with European Commission Regulation (EU) No, 2017/745, commonly known as the MDR.

2. Determine the classification of the device – Class I (self-certified), Class I (sterile, measuring, or reusable surgical instrument), Class IIa, Class IIb, or Class III.

3. For all devices except for Class I (self-certified), implement a Quality Management System (QMS) in accordance with the MDR. Most companies apply the EN ISO 13485 standard to achieve compliance. The QMS must include Clinical Evaluation, Post-Market Surveillance, and Post-Market Clinical Follow-up plans. It is also important to make arrangements with suppliers about Notified Body audits.

4. Prepare a CE Technical File or Design Dossier (Class III), providing information about the device and its intended use. Obtain a Unique Device Identifier (UDI) for the device. All devices require clinical data which should mostly refer to the subject device. Clinical studies are also required for implantable and Class III devices. Any clinical trials in Europe must be pre-approved by a European Competent Authority.

5. If based outside of Europe, appoint an Authorised Representative located in the EU who is qualified to handle regulatory issues. The representative’s name and address must be included on the device label.

6. For all devices except Class I (self-certified), the QMS and Technical File/Design Dossier must be audited by a Notified Body.

7. For all devices except Class I (self-certified), a European CE Marking Certificate will be issued for the device and an ISO 13485 certificate for the facility will be issued following successful completion of the Notified Body audit. ISO 13485 certification must be renewed every year. CE Marking certificates are generally valid for a maximum of 5 years but are typically reviewed during annual surveillance audits.

8. Prepare a Declaration of Conformity which is a legally binding document stating that the device is in compliance with applicable European requirements.

9. Once CE Marking has been affixed, the device should be registered with its Unique Device Identifier (UDI) in the EUDAMED database.

What Legislation Exists in Europe that is Related to Medical Device Regulation?

1. Medical Device Regulation EU 2017/745

Applies since 26 May 2021, following a four-year transition period. This Regulation repeals Directive 93/42/EEC on medical devices and the Directive 90/385/EEC on active implantable devices.

2. In-Vitro Diagnostic Devices Regulation EU 2017/746

Will apply from 26 May 2022, following a five-year transition period. In the meantime, manufacturers can opt to place in-vitro diagnostic devices on the market under Directive 98/79/EC or under the new Regulation if they fully comply with it.

3. Medicinal Products That Include a Medical Device (combination products) Directive 2001/83/EC

Some medicines are used in combination with a medical device, usually to enable the delivery of the medicine. If the principal intended action of the combination product is achieved by the medicine, the entire product is regulated as a medicinal product under   Directive 2001/83/EC or Regulation (EC) No 726/2004.

What is the European Medicines Agency and How do They Relate to Medical Device Compliance?

“The mission of the European Medicines Agency (EMA) is to foster scientific excellence in the evaluation and supervision of medicines, for the benefit of public and animal health in the European Union” (EMA, 2021).

The EMA is responsible for:

• Facilitating development and access to medicines

• Evaluating applications for marketing authorisation

• Monitoring the safety of medicines across their life cycle

• Providing reliable information on human and veterinary medicines in lay language

Essentially, it is the EMA who is the competent authority that is responsible for ensuring regulatory compliance of medical devices in the EU. They also play a role in supporting research and innovation and promote innovation and development of new technology by European micro, small and medium-sized enterprises.

Certification of Medical Devices in the UK

What Are the Certification Requirements for Medical Products in the UK?

Since 1 January 2021, there have been a number of changes made to legislation and requirements for those wishing to place products on the United Kingdom market. Inclusive of the secondary legislation, which has given product manufacturers in some industries extensions on the transition period/s, here are the key requirements to consider for medical devices:

• The EU no longer recognises UK Notified Bodies

• UK Notified Bodies are not able to issue CE certificates

• CE marking will continue to be recognised in Great Britain until 30 June 2023

• Certificates issued by EU-recognised Notified Bodies will continue to be valid for the Great Britain market until 30 June 2023

• All medical devices placed on the Great Britain market need to be registered with the Medicines and Healthcare products Regulatory Agency (MHRA). There are several grace periods for some devices

• If you are a manufacturer based outside the UK, you will need to appoint a UK Responsible Person who will take responsibility for the product

All medical devices, IVDs, and custom-made devices must be registered with the MHRA before they are placed on the market in Great Britain. The MHRA will only register devices where the manufacturer or their UK Responsible Person has a registered place of business in the UK. If the manufacturer is based outside of the UK, they must appoint a UK Responsible Person who has a registered place of business in the UK.

In addition to these requirements, manufacturers may be required to affix the UKCA marking on their devices. The UKCA mark is a product marking used for certain goods being placed on the Great Britain market (England, Scotland, and Wales). Manufacturers can use the UKCA mark on a voluntary basis until 30 June 2023. From 1 July 2023, a UKCA mark will be a requirement to place a device on the Great Britain market.

Where third-party conformity assessment is required, a UK Approved Body is needed. However, Class I devices and general IVD manufacturers can self-certify against the UKCA mark.

What is a UK Responsible Person?

A UK Responsible Person acts on behalf of any manufacturer who is not based in the United Kingdom and assumes the responsibility and legal obligations that a manufacturer based in the UK would undertake. In summary, the UK Responsible Person must adhere to the following:

• Ensuring that the declaration of conformity and technical files are completed and that any appropriate conformity assessment procedures have been carried out

• Keep all copies of the technical files, declaration of conformity, and certificates

• If approached by the MHRA, the Responsible Person must provide any necessary information or documentation to demonstrate the conformity of a device

• Comply with any request from the MHRA to provide samples or access to the device

• Immediately inform the manufacturer about complaints or reports from healthcare professionals, patients, and users about suspected incidents related to the device

The name and address of the UK Responsible Person must be included on the product labelling where the UKCA mark has been affixed. This does not apply to labelling for CE-marked devices.

What Legislation Exists in the UK that is Related to Medical Device Regulation?

Currently, devices are regulated under:

• Directive 90/385/EEC on active implantable medical devices (EU AIMDD)

• Directive 93/42/EEC on medical devices (EU MDD)

• Directive 98/79/EC on in-vitro diagnostic medical devices (EU IVDD)

These directives are given effect in UK law through the Medical Devices Regulations 2002 (UK MDR 2002). These regulations continue to have an effect on Great Britain after the transition period. This means that since 1 January 2021, the Great Britain route to market and UKCA marking requirements are still based on the requirements derived from current EU legislation. Once the transition period ends, these directives will be updated also.

The EU Medical Devices Regulation and EU in vitro Diagnostic Medical Devices Regulation (EU IVDR) fully apply in EU Member states from 26 May 2021 and 26 May 2022 respectively. As these regulations did not take effect during the transition period, they were not automatically retained by the EU Withdrawal Agreement Act and therefore will not automatically apply in Great Britain. This means that after the transition period has ended, the provisions contained within the EU MDR and EU IVDR will not be transposed into law in Great Britain.

What is the MHRA and How do They Relate to Medical Device Compliance?

The MHRA performs market surveillance of medical devices on the UK market and is able to take authority and make decisions on the marketing and supply of devices in the UK. They are the responsible body for the designation, auditing, and monitoring of UK Conformity Assessment Bodies.

The MHRA enforces these regulations via the Medical Devices Regulations 2002 (UK MDR 2002) and the General Product Safety Regulations 2005. These regulations are safety regulations under the Consumer Protection Act 1987 and as such give the MHRA the authority to investigate any business activity that is covered by these regulations in accordance with the Consumer Rights Act 2015.

The Future of the Medical Industry – What is in Store For the World of Compliance?

What is the Future of Medical Devices?

Medical device manufacturers were presented with an opportunity in the initial economic shock of the COVID-19 pandemic. For many industry insiders, the impact on the medical technology sector particularly has been the acceleration of trends that were already underway. Increased advancement in artificial intelligence technology, device connectivity, and data collection have enabled medical technology companies to adequately respond to the demand for critical products such as personal protective equipment (PPE) and ventilators.

The medical device industry is poised for steady growth, with global annual sales forecast to rise by over five percent per year and reach nearly US$800 billion by 2030 (KPMG, 2021). With these projections, increased demand for innovative new devices unlocks a grand potential in emerging markets such as China and India.

Traditionally, medical device companies have delivered value primarily through manufacturing and selling their products. However, as pressures on the healthcare system increase, the care delivery model is also shifting, essentially pressuring manufacturers to integrate services and data intelligence into products in order to offer holistic solutions.

Arguably, the biggest challenges within the medical device industry are political in nature. The last decade has seen a widespread backlash against globalisation (and by association globalised supply chains), from nationalist politicians and their support bases. Changes to trade agreements have far-reaching implications for the industry however, time will tell as to just how far these implications reach.

Earlier this year, the European Union’s Medical Device Regulation (2017/745) and In Vitro Diagnostic Regulation (2017/746) were enforced in order to set standards and oversight requirements for manufacturers of medical devices and in vitro diagnostic solutions that intend to distribute their products in the European Union. This was done in order to replace the decade-old regulations that were outdated. However, these new introductions also have posed some significant challenges to healthcare technology organisations, including higher costs and longer timeframes for developing new products.

There are a lot of potential growth opportunities that exist in the medical device industry, especially with major advances in robotics technology which have led to a huge spike in demand for minimally invasive robotic surgery (MIRS), causing the surgical robot market to experience double-digit growth. This trend is set to continue on an upward trajectory, with the global number of MIRS procedures set to more than double to 2 million by 2025, while the market is predicted to grow from $5.5bn to over $24bn (SRG, 2021).

Medical device manufacturers, while being faced with some new challenges, are also positioned with enhanced opportunities to develop new and innovative strategies that will allow them to thrive in the new and rapidly changing regulatory environment. The key is to be prepared, aware, and to think ahead. With these measures, the world of medical devices and compliance can go hand in hand, and essentially support the other to thrive in a rapidly evolving world.

Advances in Medical Technology

Technological advances are not only revolutionising the medical device industry by increasing the number of connected medical devices available to the market, but also strengthening their role in healthcare.

Developments in areas such as wireless technology and smaller devices are improving the landscape of the interconnectedness of devices. This is aiding healthcare organisations to produce better patient outcomes, lower costs, and presents an additional revenue source.

The following are some of the major trends attributed to technological advances in medical device production, which presents new opportunities and challenges for medical device companies.

1. Internet of Medical Things (IoMT) to modernise healthcare

Significant innovations in new technologies are driving medical devices that generate data into care pathways, creating alliances with IoMT systems. These advancements help aid in the monitoring of biomedical signals and the diagnosis of diseases without human intervention. The IoMT market is expected to grow by $285.5 billion by 2029, which is a compound CAGR of 28%.

2. Device connectivity as another source of revenue

Medical Technology is also advancing in the area of data. Software as a medical device (SaMD) is transforming healthcare, empowering patients to be better informed and involved in their own health conditions. With this increase in demand, it’s expected that governments will need to begin implementing more stringent regulations surrounding devices and privacy, similar to what is being done in many regions relating to the world of artificial intelligence.

3. Robotics

The advancement in robotic surgery has led to an increased demand for minimally invasive robotic surgery (MIRS), resulting in a double-digit growth rate within the last five years. The surgical robot market is expected to grow from $5.5 billion to over $24 billion by 2025, doubling the current MIRS procedures worldwide.

Robotic surgery can be safer for patients due to quality precision, better ergonomics, and the ability to have better control. On the patient side, there is a growing preference for minimally invasive procedures with the use of robotics due to smaller incisions, less blood loss, decreased hospital stay, and a quicker recovery time. Overall, decreasing complications through minimally invasive surgery is a win-win for both patient and doctor.

The Vital Nature of Ensuring Medical Device Compliance

Medical device companies have made significant breakthroughs in recent years, bringing an entirely new generation of life-saving tools to the market. Organisations should anticipate additional regulatory compliance measures on the horizon. Medical device regulations are an important part of ensuring patients have access to safe and effective care, but they do come with costs and challenges, some of which can be abated through the strategic deployment of new processes and technologies.

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