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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.
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.
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.