CBI | Market Intelligence Product Factsheet Cloves in Germany | 1

CBI Product Factsheet:

Surgical instruments in Belgium, the Netherlands and Luxembourg

CBI | Market Intelligence Product Factsheet Surgical instruments in Belgium, the Netherlands and

Luxembourg | 2

Introduction

The market for surgical instruments is growing in the Benelux (Belgium, the Netherlands and Luxembourg). There is increasing demand for safe, and cost- and time-effective solutions, as well as for instruments suited for minimally invasive surgery. Imports of surgical instruments to the Benelux reached €3.8 billion in 2014, of which 23% were from developing countries. Belgium was the main importer of surgical instruments, and Luxembourg the leading importer from developing countries.

Product description

Surgical instruments are tools or devices designed to performing specific functions in surgery, such as cutting, grasping, clamping, retracting and suturing. One CN code has been selected for surgical instruments. See Table 1 that also shows the Prodcom code used in the production statistics for surgical instruments. Table 1: Selected products based on CN and Prodcom nomenclature

CN code Prodcom code Description

90189085 32501370

32501379

Instruments and appliances used in medical, surgical or

veterinary sciences,

Source: CN and Prodcom Nomenclature

In this survey, ‘surgical instruments’ refers the product selection in Table 1, unless stated otherwise.

Quality

Surgical instruments for the EU market including the Benelux must comply with the Medical Devices Directive 93/42/EEC. For more information, see Market Requirements below.

Labelling

The requirements for labelling of 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 into the EU and distributed in the

EU, the label, the outer packaging, and instructions for use must contain the name and address of the authorised

representative if the manufacturer does not have a registered place of business in the EU;

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 label must state ‘custom-made device’;

If the device is for clinical investigations, the label must state ‘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 indication may be included in the

batch or serial number;

Where applicable, method of sterilisation.

Materials

Surgical instruments are usually made of stainless steel but other metals, such as titanium, chromium, vanadium and molybdenum, are also used.

Packaging

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

CBI | Market Intelligence Product Factsheet Surgical instruments in Belgium, the Netherlands and

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There is also 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. The International Trade Centre (ITC) provides additional information on packaging for exporters.

Demand

Imports

Figure 1: Imports of surgical instruments to the Benelux, by main origin, € million, 2010-2014

Source: Trademap

Figure 2: Leading suppliers of surgical instruments to the Benelux, € million, 2014

Source: Trademap

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Figure 3: Imports of surgical instruments to Belgium, the Netherlands and Luxembourg by main origin, € million, 2010-2014

Source: Trademap

Imports of surgical instruments to the Benelux reached €3.8 billion in 2014. Average annual growth in 2010-2014

was 8.9%.

The developing country share of Benelux imports increased from 13 to 23% in the period under review, with a peak

of 25% in 2012. This peak is the result of a peak in developing country imports to Luxembourg. For the foreseeable

future, the developing country share is forecast to show small growth in the range of 1 to 3%.

The leading importer to the Benelux is Belgium (52%), followed by the Netherlands (32%), and Luxembourg (15%).

Luxembourg is ahead of Belgium and the Netherlands in imports from developing countries. Growth of these imports

between 2010 and 2014 was also strongest in Luxembourg (€380 million) and Belgium (€154 million). Dutch imports

from developing countries decreased slightly by €13 million.

The import shares for each source differ. The main source of imports to Belgium is intra-Europe trade, to Luxembourg

mainly imports from developing countries, and the Netherlands sources imports from the rest of the world. Belgium

has a leading position because the country is a trade hub for many global medical devices companies, and is

especially a trade hub for surgical instruments produced in other European countries (see Figure 3).

Imports of surgical instruments are expected to show moderate growth in the foreseeable future in the range of 3 to

5%.

Leading suppliers

The leading suppliers of surgical instruments to the Benelux vary, with the top three suppliers being USA,

Luxembourg itself and Mexico.

The only developing countries on the list of leading suppliers are Mexico (€612 million) and Costa Rica (€92 million).

Other developing countries exporting surgical instruments to the Benelux are China (€50 million), Vietnam (€39

million), Dominican Republic (€34 million) and Malaysia (€14 million).

The leading suppliers to the Benelux differ considerably per country. USA is the leading supplier to the Netherlands

(€648 million), and supplies to Belgium (€457 million) and Luxembourg (€23 million). The leading supplier to Belgium

is Luxembourg (€667 million), which fully accounts for Luxembourg’s position in the Benelux leading suppliers.

Mexico is the leading supplier to Luxembourg (€534 million) and supplies Belgium (€63 million) and the Netherlands

(€16 million).

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Tip:

Benchmark your company against your peers in Mexico, Costa Rica, China, Vietnam, Dominican

Republic and Malaysia. Several factors can be taken into account, such as market segments served,

perceived price and quality level, and countries served. A useful source to find exporters/producers of

surgical instruments per country is the ITC Trademap.

CBI | Market Intelligence Product Factsheet Surgical instruments in Belgium, the Netherlands and

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Exports

Figure 4: Exports of surgical instruments from the Benelux, by main destination, € million, 2010-2014

Source: Trademap

Figure 5: Exports of surgical instruments from Belgium, the Netherlands and Luxembourg by main destination, € million, 2010-2014

Source: Trademap

Exports of surgical instruments from the Benelux have shown an upward trend in the last four years, and amounted

to € 4.3 billion in 2014. In 2012, there was a peak in intra-Europe exports, mainly due to a peak in exports from

Luxembourg. In 2013, exports returned to their regular pattern. Average annual growth in 2010-2014 was 9.9%.

Luxembourg had an exceptional year for international trade in 2012, as evidenced by its unusually high imports from

developing countries and intra-Europe re-exports.

The developing country share of Benelux exports reached 9.5% in 2014. Most exports go to European countries

(77%) and include some re-exports of imports from developing countries. For the foreseeable future, developing

country share is forecast to show small growth in the range of 1 to 3%.

The leading exporter in the Benelux is Belgium, accounting for 51%, ahead of the Netherlands (35%) and

Luxembourg (14%).

Of the total of €4.3 billion, €685 million goes to Belgium largely because of Luxembourg’s intensive exports to

Belgium. Germany is in second position (€ 576 million) followed by France (€503 million).

The European exports of surgical instruments are expected to show moderate growth in the foreseeable future in the

range of 2 to 4%.

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CBI | Market Intelligence Product Factsheet Surgical instruments in Belgium, the Netherlands and

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Production and apparent demand

Figure 6: Production of surgical instruments in the Benelux, 2010-2014, € million

Source: Eurostat Prodcom

Figure 7: Main Benelux producers of surgical instruments, 2014

Source: Eurostat Prodcom

Production in the Benelux totalled €4.4 billion in 2014, after an average annual increase of 26% in the period 2010-

2014. This growth rate might be considerably inflated by the seemingly incomplete registered production rates for

Belgium in 2010, 2011 and 2013, which account for the fluctuating pattern in Figure 6.

Belgium (€2.2 billion) accounted for 50% of total Benelux production in 2014, the Netherlands (€1.6 billion) for 36%,

and Luxembourg (€ 616 million) for 14%.

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Belgium 50%Netherlands 36%

Luxembourg14%

Tip:

The presence of producers in the Benelux offers opportunities for subcontracting for developing

country exporters. Links to databases of producers of surgical instruments can be found in Useful

Sources below.

CBI | Market Intelligence Product Factsheet Surgical instruments in Belgium, the Netherlands and

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Figure 8: Apparent demand for surgical instruments in the Benelux, 2010-2014, € million

Source: Eurostat Prodcom

Apparent demand in the Benelux totalled €3.8 billion in 2014, after an average annual increase of 27% in the period

2010-2014. This growth rate might also be considerably inflated by the seemingly incomplete registered production

rates for Belgium in 2010, 2011 and 2013, used to calculate the demand.

Belgium is the dominant producer of surgical instruments in the Benelux at 52% and has the largest apparent

demand. Belgium is followed by the Netherlands with 33% of Benelux demand and Luxembourg with 15%. These

figures should be viewed with caution because Belgium is a trade hub for many global medical devices companies.

This may lead to inaccurate apparent demand.

Macroeconomic indicators

Figure 9: Real GDP, percentage change on the previous year

Source: OECD Economic Outlook 96 database

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CBI | Market Intelligence Product Factsheet Surgical instruments in Belgium, the Netherlands and

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Figure 10: Number of senior citizens (65+), % change from previous year

Source: Eurostat EUROPOP2013 The major determinant of demand for surgical instruments is spending in the medical sector. In turn, this demand is

stimulated by economic growth and an ageing population (an ageing population needs more medical care). In each

focus country, Gross Domestic Product (GDP) and the number of senior citizens are expected to show continued

growth year-on-year in the foreseeable future. This is a good basis for estimating demand for and growth in imports

in the coming years.

Profitability of surgical instruments imports is influenced by the euro/US dollar exchange rate because many medical

devices sourced globally are paid in US dollars. While the euro/US dollar exchange rate was not forecast to go beyond

0.80 until 2020, the exchange rate was between 0.88 and 0.93 in the period March-October 2015. This has a large

impact on the price level of imports. If this is the situation for some years, it will have a negative impact on European

imports paid for in US dollars versus local European production.

For more information on the sector, see CBI Trade Statistics for Medical and Laboratory Devices.

Trends offering opportunities

Safety

Innovative techniques and products are constantly being developed to further increase patient safety. Such innovations include an electronic instrument that improves precision in spinal surgery and an actuating device that reduces needle misplacement errors.

Disposability

There is a trend to disposable surgical instruments that are more cost- and time-effective than reusable products that need sterilisation after each use. Disposable surgical instruments can be made from high-grade polymer but also from stainless steel, as are most reusable instruments.

Minimally invasive surgery

There is continual innovation in minimally invasive surgery. Compared to regular procedures, minimally invasive surgery involves smaller incisions, lower risks of infection and shorter recovery time. There are benefits for the patient, such as minimal blood loss, skin scarring, duration of hospital stay and trauma. This type of surgery can increase the number of operations in day surgery and faster turnaround of patients while reducing costs. Instruments especially suited for minimally invasive surgery include pivoting retractors and lighted blades.

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Tip:

If the euro remains at approximately US$ 0.90, developing country producers should increasingly focus

on cost reduction to remain competitive in the European market.

CBI | Market Intelligence Product Factsheet Surgical instruments in Belgium, the Netherlands and

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For more information, see CBI Trends for Medical and Laboratory Devices.

Market requirements

Mandatory

Surgical instruments for the EU market including the Benelux require CE Marking. To obtain this, your products must comply with the Medical Devices Directive 93/42/EEC on 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 EU regulations to “achieve a suitable, robust, transparent and sustainable regulatory framework” for the development of safe, effective and innovative medical devices. On 5 October 2015, the Ministers of the European Union countries agreed on a general approach to the package. The new regulations are expected to be implemented by 2018-2020.

Depending on the specific product, your surgical instruments may also have to comply with the Waste Electrical & Electronic Equipment (WEEE) Directive 2012/19/EU. This directive aims to increase recycling and/or re-use of waste of electrical and electronic equipment.

Additional requirements

Complying with voluntary standards, such as IEC/EN 60601, could help you obtain CE Marking for your product. Other voluntary standards provide organisational (such as, ISO 13485), environmental and social (labour) requirements. Governments, industries and consumers are increasingly aware of sustainability issues. The Ecodesign Directive

2009/125/EC helps to improve the energy efficiency of products and is complemented by the Energy Labelling Directive,

with 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. Recently, the concept of Corporate Social Responsibility (CSR) has become more important in the medical device sector. Buyers are increasingly selecting suppliers based on their ethical and social responsibility measures. For surgical instruments, no duty is levied on EU imports from countries outside the EU.

Tips:

Invest in R&D to develop safe, cost- and time-effective solutions.

Include in your product range surgical instruments especially suited for minimally invasive surgery.

Tips:

Consult the European Commission Blue Guide that sets out how to implement the EU product rules on

medical devices.

For more information on the Medical Devices Directive, see the accompanying guidance documents to

assist stakeholders in implementing directives related to medical devices.

Keep up-to-date with the revision of the Medical Devices Directives.

Tip:

Consult the Frequently Asked Questions (FAQ) on the WEEE Directive.

CBI | Market Intelligence Product Factsheet Surgical instruments in Belgium, the Netherlands and

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Competition

As competition for surgical instruments does not differ significantly from Medical and Laboratory Devices, see CBI Competition for Medical and Laboratory Devices and CBI Top 10 Tips for Doing Business with European Buyers for an overview.

Trade channels and market segments

As market channels for surgical instruments do not differ significantly from Medical and Laboratory Devices, see CBI Market Channels and Segments for Medical and Laboratory Devices for an overview. Potential trading partners include: Belgium Aequitas-Medical - distributor

Cantaert Medical - distributor

Dermat Medical Supplies - distributor

DL Medical - distributor

Heyer Benelux - distributor

Romed - distributor

Netherlands Daxtrio - distributor

Delta Medic - distributor

Endomed - distributor

Intodis - distributor

Laméris Ootech - distributor

Medicom Europe - manufacturer

MedSupport Systems - distributor

Meekers Medical - manufacturer and distributor

NF Medical - distributor

Stöpler - distributor

Van Straten Medical - manufacturer

Luxembourg Hospilux - distributor

Centermed - distributor

Meditec - distributor

Benelux distributors often represent key international players in the USA, UK and Germany, such as Aesculap, a division of B. Braun specialised in surgical instruments.

Useful sources

Finding prospects: ESTA Healthcare, FHI, Medassort, Qmed

Tips:

For more information on gaining access to the European market, see:

EU Export Helpdesk for requirements, tariffs, statistics and preferential arrangements

ITC Market Access Map for technical standards

ITC Standards Map for voluntary standards.

In the ISO Catalogue, click on TC 76, 84, 194 and 210 for an overview of ISO standards.

Search EN norms in the online shop of the British Standards Organisation.

Consult the Frequently Asked Questions (FAQ) on the Ecodesign Directive.

Use sustainable materials in your products, such as biodegradable, bio-based and recycled plastics.

Consult the Frequently Asked Questions (FAQ) on Green Public Procurement.

Have your CSR policy in order and advertise it clearly, for instance on your website and in brochures,

preferably using quotes from your CE audit report.

CBI | Market Intelligence Product Factsheet Surgical instruments in Belgium, the Netherlands and

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Benelux associations: Belgian Collegium Chirurgicum, Belgian Surgical Association, Dutch Surgical Association,

Luxembourgian Surgical Association, Nefemed, UNAMEC

European associations: Medtech Europe (Eucomed), European Hospital and Healthcare Federation, European Surgical

Association

Magazines and news: Dutch Surgical Magazine, Medical Device and Diagnostic Industry

Trade fairs: Healthcare Expo (Belgium), MEDICA (Germany), Medtec Europe (Germany), Zorgtotaal (Netherlands)

For more information, see CBI Finding Buyers in the Medical and Laboratory Devices sector.

CBI Market Intelligence

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marketintel@cbi.eu

This survey was compiled for CBI by Globally Cool – Creative Solutions for Sustainable Business

in collaboration with CBI sector expert Leendert Santema.

Disclaimer CBI market information tools: http://www.cbi.eu/disclaimer

May 2016