In order to sell medical devices and IVDs in the European Union, you must first CE Mark your product.
The CE Mark is not a quality mark, nor is it intended for consumers. CE marking indicates to EU regulators that your device meets all applicable requirements of the appropriate EU Directive, such as the Medical Devices Directive (MDD), In Vitro Diagnostic Device Directive (IVDD) or Active Implantable Medical Device Directive (AIMD), as they apply to your product.
SmartMBS has successfully assisted clients in obtaining Wholesale Distribution Authorisation (WDA) from the Irish Health Products Regulatory Authority (HPRA) as well as CE marking in compliance with EU directives.
In our experience, companies may not always be aware of their obligations under GDP. In particular, understanding that companies that do not physically handle medicinal products but procure and supply them via financial transactions (e.g. out of an office) are subject to GDP requirements and therefore, also require a WDA.
For example, this is sometimes seen when the Marketing Authorisation Holder is involved in the sale of a Finished Product and does not hold a WDA or MIA.
If you need clarification as to whether your particular activity (or activities) fall under the wholesale regulatory requirements or not, our SmartMBS technical team can provide expert input through advice on a case-by-case basis and assist you in determining if you require a WDA.