Exporting orthopaedic appliances and artificial joints to Europe

The market for orthopaedic appliances and artificial joints is growing in Europe. There is an increasing demand for innovative, cost- and time-effective, and minimally invasive solutions. Imports to Europe reached €6.2 billion in 2015. In the period 2010–2015, the total European imports grew by 7.4% per year. The imports from developing countries showed exceptional performance with 19.1% growth per year, reaching €382 million in 2015. The high growth of imports from Malaysia, Mexico, the Philippines, Romania and China indicates that Europe offers good opportunities for products from relatively low-cost supplying locations.

1. Product description

Orthopaedic or fracture appliances

Orthopaedic appliances are worn, carried or implanted in the body to compensate for a defect. They include crutches, surgical belts and trusses, and appliances fixated during surgical procedures. Splints and other fracture appliances are orthopaedic appliances designed to perform a therapeutic or corrective function. Splints can be applied internally or externally.

Artificial joints

Artificial joints are used to replace painful, arthritic, worn or cancerous parts of the joint, with artificial surfaces shaped to allow joint movement. There are different types of artificial joints; for instance, for knee, elbow and hip. Furthermore, there are differences in the way that the joint is fixated (cemented or uncemented), leading to differences in design.

One CN code has been selected for orthopaedic appliances and artificial joints. See Table 1, which also shows the Prodcom code used in production statistics for orthopaedic appliances and artificial joints.

Table 1: Selected products based on CN and Prodcom nomenclature

CN code	Prodcom code	Description
902110	32502239	Orthopaedic or fracture appliances
902131	32502235	Artificial joints

Source: CN and Prodcom nomenclature.

In this survey, “orthopaedic appliances and artificial joints” refers to the product selection in Table 1, unless stated otherwise.

Quality

Orthopaedic appliances and artificial joints for the EU market must comply with the Medical Devices Directive 93/42/EEC and, depending on the specific product, with the Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC. For more information, see the “Market requirements” below.

Labelling

The requirements for labelling medical devices for the European Union are set out in Annex I, Paragraph 13, of the Medical Devices Directive 93/42/EEC.

The label must state the following:

• the name or trade name and address of the manufacturer. For devices imported in the European Union for distribution in the European Union, the label, outer packaging and instructions for use must also contain the name and address of the authorised representative if the manufacturer does not have a registered place of business in the European Union;
• information essential to identify the device and the contents of the packaging, especially for the users;
• where appropriate, the word STERILE;
• where appropriate, the batch code preceded by the word LOT or the serial number;
• where appropriate, the date by which the device should be used in safety, expressed as year and month;
• where appropriate, an indication that the device is for single use. A manufacturer's indication of single use must be consistent across the European Union;
• if the device is custom-made, the phrase “custom-made device”;
• if the device is for clinical investigations, the phrase “exclusively for clinical investigations”;
• any special storage and/or handling requirements;
• any special instructions for use;
• any warnings and/or precautions to be taken;
• year of manufacture for active devices other than those covered under (e). This may be included in the batch or serial number;
• where applicable, method of sterilisation.

Packaging

Medical devices require sterile packaging in compliance with EN868 (Part 1). Part 2 and 10 relate to the requirements and test procedures for packaging materials. These tests can be used to show that all requirements have been complied with.

There is an ISO standard for sterile packaging of medical products, ISO 11607. This ISO standard is very similar to EN868 and has two parts: Part 1 on the requirements and test procedures for packaging materials, and Part 2 on the validation requirements of packaging processes. While EN868 is mandatory, ISO is a voluntary standard and is often requested by customers.

More general legislation applicable to medical devices packaging is the European Packaging and packaging waste legislation. This legislation restricts the use of certain heavy metals and states other requirements. The EU also has requirements for Wood packaging materials used for transport (WPM), such as packing cases, boxes, crates, drums, pallets, box pallets and dunnage.

2. Which European markets offer opportunities for orthopaedic appliances and artificial joints?

Imports

In the last five years, the total European imports of orthopaedic appliances and artificial joints grew in value by 7.4% annually, reaching €6.2 billion in 2015. The imports from developing countries grew at a very high rate (by 19.1%), reaching €382 million. It is expected that imports of orthopaedic appliances and artificial joints from developing countries to Europe will continue to grow in the next few years at a relatively high rate. A rough estimation, based on industry sources, predicts a growth of between 5 and 15% per year on average. The total imports to Europe will grow at between 3 and 9% annually in the next few years.

Germany is the largest importer of orthopaedic appliances and artificial joints, amounting to €1.3 billion in 2015. It is followed by France (€1.0 billion), Belgium (€741 million), the Netherlands (€734 million) and the UK (€710 million).

Leading suppliers

The United States of America is by far the largest supplier to Europe. The country represents more than 20% of European imports of orthopaedic appliances and artificial joints. It is followed by several European countries, of which Germany and Switzerland are the largest. China takes the ninth position as supplier (€162 million, +17.6% per year) and Mexico the tenth position (€122 million, +23.1% per year). Note that production in Mexico mostly comes from facilities owned by the large American manufacturers of medical devices. Other developing countries with exports to Europe are Tunisia (€23 million, +8.6% per year), Malaysia (€18 million, +35.5% per year), the Philippines (€14 million, +19.6% per year) and Turkey (€10 million, +17.3% per year).

Orthopaedic appliances and artificial joints imported from outside Europe are mostly exported directly to the target country. The reason is that the European market is rather scattered, with many companies operating in one country only. As a consequence, this trade flow does not lead to intra-European trade flows.

In the list of the 20 leading European suppliers of orthopaedic appliances and artificial joints, the highest growth in annual import was recorded by a group of five relatively low-cost supplying countries: Malaysia, Mexico, the Philippines, Romania and China. This development shows that Europe offers a market for products from relatively low-cost supplying locations.

Exports

The total European exports of orthopaedic appliances and artificial joints increased by 7.9% per year between 2011 and 2015 to €7.3 billion. Exports of European orthopaedic appliances and artificial joints were mainly destined for other European countries (55% share of the total exports). However, exports to developing countries and to the rest of the world showed higher annual growth (by 18.6% and 9.7% per year on average, respectively).

In 2015, European exports to developing countries amounted to €723 million, 10% of the total European exports. For the coming years, this share of developing countries is forecast to increase slightly.

Germany is the largest exporter of orthopaedic appliances and artificial joints in Europe (€1.8 billion in 2015, 25% of the total European exports), followed by Belgium (20%), France and the Netherlands (14%), and Ireland (12% share).

Production 

The production of orthopaedic appliances and artificial joints in Europe peaked at €7.0 billion in 2015, following an average annual increase of 6.4% in the period 2011–2015. Germany is the largest producer of orthopaedic appliances and artificial joints in Europe (€1.4 billion in 2015), followed by Belgium (€1.3 billion) and the Netherlands (€1.1 billion).

The strongest production growth was seen in Ireland (by 20% per year) and the Netherlands (19%). In some other countries production declined, most notably in the United Kingdom (by 7.4%) and Sweden (7.8%).

Demand 

With the exception of 2013, when demand showed a tiny dip, European demand increased every year in the period under review. The demand reached €5.9 billion in 2015, following an average annual increase of 4.8% in the period 2011–2015. Germany (€995 million) and France (€954 million) are the largest markets for orthopaedic appliances and artificial joints, together representing 33% of the total European market. In terms of applications, knee replacements are the number one product on the European market, followed by hip replacements.

Other countries with high demand are the Netherlands (€954 million), the United Kingdom (€659 million), Belgium (€619 million) and Italy (€555 million). Of these countries, the Netherlands and France showed the highest annual growth on average (by 12.7% and 7.3%, respectively) between 2011 and 2015.

3. Which trends offer opportunities on the European market for orthopaedic appliances and artificial joints? 

Ageing population

The population in many European countries is ageing rapidly. Many seniors will need hip and knee implants, as well as other orthopaedic appliances and/or artificial joints. This fuels demand for orthopaedic appliances and artificial joints in these countries.

Materials for implants

There are several trends in biomaterial needed to fabricate orthopaedic implants and artificial joints. For instance, implants infused with human growth proteins prompt the body to regenerate the lining. Over time, the implant will deteriorate as the body grows the missing tissue. Another innovation in materials for orthopaedic appliances is injectable bone substitutes that focus on bone infections, bone augmentation and vertebral applications.

Efficient shaping/3D printing

There is a demand for manufacturing processes that shape orthopaedic appliances and artificial joints more efficiently and cost-effectively. One of these is 3D printing, for which experts predict a key role in orthopaedics.

Smart orthopaedic appliances

Numerous companies are working on smart orthopaedic appliances. They incorporate technology that enables data collection, which allows doctors and patients to monitor rehabilitation more effectively. In the future, orthopaedic implants could monitor how well implants are performing inside the patient’s body, measuring how well bone attaches to them or detecting problems such as inflammation or infection. Examples are smart spinal implants and smart implants for orthopaedic surgery.

Minimally invasive surgery

Compared to regular procedures, minimally invasive surgery involves smaller incisions, lower risks of infection and a shorter recovery time. This type of surgery has benefits for the patient; for instance, minimal blood loss, skin scarring, duration of hospital stay and trauma. It can increase the number of operations in day surgery and ensure a faster turnaround of patients, while reducing costs. In orthopaedics, arthroscopy is increasingly used to visualise, diagnose and treat problems inside a joint.

4. Which requirements should orthopaedic appliances and artificial joints comply with to be allowed on the European market? 

Requirements can be divided into (1) legal requirements, which you must meet in order to enter the market, and (2) non-legal requirements, which are those most of your competitors have already implemented; in other words, the ones that you need to comply with in order to keep up with the market. See our study of EU buyer requirements for medical and laboratory devices for a general overview of requirements. Below are the requirements that specifically apply to orthopaedic appliances and artificial joints.

Mandatory

Orthopaedic appliances and artificial joints for the EU market require CE marking. To obtain this, your products must comply with the Medical Devices Directive (MDD) 93/42/EEC or, depending on the specific product, the Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC. These directives ensure the safety and performance of medical devices. The requirements include a quality system for design, manufacture, and final product inspection and testing (such as ISO 13485).

In 2012, the European Commission presented a proposal to replace the three European medical devices directives with two European regulations to “achieve a suitable, robust, transparent and sustainable regulatory framework” for the development of safe, effective and innovative medical devices. In June 2016, the Ministers of the European Union countries agreed on the final text of the new directive. The final formal adoption is expected in the first semester of 2017 and the new regulations will be implemented by 2018–2020. Among the most important implications of the new directive for producers of medical devices is the fact that the producer needs to deliver stronger clinical evidence, along with more data, to prove the safety of the device.

Additional requirements

Complying with voluntary standards, such as IEC/EN 60601, could help you obtain CE marking for your product.

The Ecodesign Directive 2009/125/EC helps to improve the energy efficiency of products and is complemented by the Energy Labelling Directive for labelling requirements.

In 2014, the European Commission published the Green Public Procurement (GPP) Criteria for Electrical and Electronic Medical Devices (Healthcare EEE), a voluntary instrument with clear, verifiable, justifiable and ambitious environmental criteria, based on a life cycle approach and scientific evidence.

Governments, industries and consumers are becoming increasingly aware of sustainability issues. Recently, the concept of Corporate Social Responsibility (CSR) has become more important in the medical devices industry. Buyers are increasingly selecting suppliers based on their ethical and social responsibility measures.

For orthopaedic appliances and artificial joints, no duty is levied on EU imports from outside the EU.

5. Through which channels can you get orthopaedic appliances and artificial joints on the European market? 

You should focus on European producers of orthopaedic appliances and artificial joints, and try to work for them as a subcontractor. This strategy is a much easier way of developing exports to Europe, as it is rather difficult to convince European companies requiring orthopaedic appliances and artificial joints to buy from a new supplier in a developing country. As the market channels and opportunities for orthopaedic appliances and artificial joints do not differ significantly from the Medical and Laboratory Devices sector, see CBI Market Channels and Segments for Medical and Laboratory Devices for an overview.

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