BELGIUM MEDICAL DEVICES MARKET

INTRODUCTION

 Although there are some variances, most of Belgium's medical device regulations are similar to those of the European Union.

Only products with the correct CE Markings are allowed on the Belgian market because Belgium is a member of the European Union.

The maker of a Class IIa, Class IIb, or Class III medical equipment must get in touch with a Notified Body (NB) in order to obtain a CE mark.

The NB will then deliver the certificate following the completion of procedure inspections. The CE marking will be accompanied by a four-figure number issued by the NB if the NB is involved in certifying the conformity.

BELGIUM MEDICAL DEVICES MARKET SIZE AND FORECAST

The Belgium Medical Devices Market accounted for $XX Billion in 2023 and is anticipated to reach $XX Billion by 2030, registering a CAGR of XX% from 2024 to 2030.

BELGIUM MEDICAL DEVICES MARKET NEW PRODUCT LAUNCH

Two new medical device decrees were issued in the Belgian official gazette. Even while the decrees are intended to complete the transposition of the European in vitro diagnostics (IVDs) regulations into national laws, a thorough examination of their provisions reveals that they actually have a considerably wider scope, having implications for all Belgian medtech companies.

Adoption of EU medical technology regulations, A four-fold legal and regulatory framework went into effect last year, marking the beginning of Belgium's attempts to implement the European MDR. 

The MDR repeal and amendment decree was required to streamline regional legacy device regulations and bring them into line with the new, post-MDR framework.

The clinical investigations decree applied specifically to studies conducted with medical devices for a variety of purposes, some of which are not covered by the MDR.

EU IVD laws being implemented, As with other medical devices covered by the MDR, IVDs covered by the IVDR and installed, made available, or put into operation on the Belgian market are subject to a legislation.

This is also true for other medical devices covered by the MDR. Contrary to what its name implies, the directive includes other sorts of devices in addition to IVDs.

On the grounds that medical devices are now governed by the MDR, independent of IVDR regulations, the decree also repeals provisions and modifies references in other decrees.

BELGIUM MEDICAL DEVICES MARKET COMPANY PROFILES

• Lusha
• Orfit
• Trasis
• Nateen
• Life medical 

THIS BELGIUM MEDICAL DEVICES MARKET REPORT WILL ANSWER FOLLOWING QUESTIONS

1. How many Medical Devices are manufactured per annum in Belgium? Who are the sub-component suppliers in this regions?
2. Cost breakup of a Belgium Medical Devices and key vendor selection criteria
3. Where are the Medical Devices manufactured? What is the average margin per unit?
4. Market share of Belgium Medical Devices market manufacturers and their upcoming products
5. Cost advantage for OEMs who manufacture Belgium Medical Devices in-house
6. key predictions for next 5 years in Belgium Medical Devices market
7. Average B-2-B Medical Devices market price in all segments
8. Latest trends in Medical Devices market, by every market segment
9. The market size (both volume and value) of the Medical Devices market in 2024-2030 and every year in between?
10. Production breakup of Medical Devices market, by suppliers and their OEM relationship