Comprehensive manufacturing, packaging, labelling, and distribution support for medical devices and IVDs.
Secondary manufacturing of medical devices and in vitro diagnostic medical devices (IVMD) encompasses all processes that take place after primary manufacturing, including packaging, labelling, sterilization, and preparation for distribution.
CEHP provides expert consulting and operational support to ensure your secondary manufacturing processes meet all regulatory requirements under MDR (EU 2017/745) and IVDR (EU 2017/746), while optimizing efficiency and quality.
Whether you are establishing new manufacturing operations or optimizing existing ones, our team brings the expertise needed to navigate the complex regulatory landscape of medical device manufacturing in Europe.
The European Commission has recently adopted measures under the International Procurement Instrument (IPI) following its first investigation into barriers affecting EU access to third-country public procurement markets. Under these measures, EU contracting authorities may exclude Chinese companies from public procurement procedures for medical devices exceeding EUR 5 million, and successful tenders may include no more than 50% of input materials originating from China, unless specific exemptions apply.
These measures are proportionate, compliant with EU international obligations (including WTO rules), and designed to ensure the availability of essential medical devices for EU healthcare systems, while protecting EU enterprises from unfair and discriminatory treatment.
Establishing manufacturing or assembly operations in Bulgaria offers a sustainable and fully compliant pathway to continued access to the EU market.
Products manufactured in Bulgaria are legally treated as EU-origin products
They are fully eligible for EU public procurement, including large-scale government tenders
They benefit from unrestricted access to the EU Single Market
Clinical investigations and performance studies may be conducted on a Bulgarian (European) patient population, strengthening regulatory acceptance and market credibility
Full compliance with MDR (EU 2017/745) and IVDR (EU 2017/746) can be ensured from the earliest development stage
A comprehensive end-to-end cooperation model, covering the entire lifecycle of medical devices and IVD products.
This initiative responds to the EU's objective to protect EU enterprises from long-standing discriminatory practices, while maintaining an open and rules-based trade framework. At the same time, it enables manufacturers to:
Contact us to learn how CEHP can support your secondary manufacturing needs for medical devices and IVDs.
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