Medical Device Regulation

MegaGen Benelux and suppliers

From 26 May 2021, this new European regulation applies to manufacturers, manufacturers’ representatives (if the manufacturer is based outside the EU), importers and distributors of medical devices, in addition, there are also changes for healthcare institutions and healthcare providers who use these devices. Important goals of this regulation are to provide more clarity to patients and to improve the traceability of medical devices.

MegaGen Benelux B.V. is MDR compliant according to article 14, “General obligations of distributors”, and article 13, “General obligations of importer”, since MegaGen Benelux is both the importer and distributor of your products. In addition, the manufacturers of megagen Benelux products are compliant according to article 10, “General obligations of manufacturers” and if necessary according to article 11, “Authorized representative”.

MDR guidelines distributor

MegaGen Benelux complies with the MDR guidelines for distributors of medical devices, article 14:

1. MegaGen Benelux B.V. exercises with high care the activities in connection with the applicable requirements as stated in MRD, article 14.
2. MegaGen Benelux B.V. has checked whether the following requirements are met:

• The devices are CE marked and there are EU declarations of conformity for the devices
• The devices shall be accompanied by a correct label (see explanation of packaging labelling) and instructions for use from the manufacturer corresponding to the information to be provided in Article 10(11)
• The devices shall be provided with the information of the importer in accordance with Article 13 paragraph 3
• Where applicable, a UDI has been assigned by the manufacturer in accordance with Article 17

1. Storage and transport conditions shall comply with safety and performance requirements and with the conditions laid down by the manufacturer
2. The manufacturer and the authorised representative (importer n.v.t., in relation to the same organisation) shall be informed if the distributor considers that the devices are not in conformity with the Regulation. If the distributor considers or has reason to believe that the device poses serious risks, the authorities and the CE certification body will also be informed, cooperation will also be provided to the above parties, if necessary
3. There is a system whereby the complaints received, suspected incidents or non-compliance with the requirements of this Regulation concerning the devices originating from the healthcare provider, patient or user can be shared with the manufacturer and authorised representative (importer n.v.t., in relation to the same organisation)
4. Go to the contact form at the bottom of this page.
5. The distributor may, at the request of the authorities, share information and documentation necessary to demonstrate the conformity of a device.

MDR guidelines importer

MegaGen Benelux complies with the MDR guidelines for importers of medical devices, article 13.

1. MegaGen Benelux B.V. only markets medical devices if they are in accordance with the MDR2017/745 and in addition MegaGen Benelux B.V. meets the applicable requirements as stated in MRD, article 13
2. MegaGen Benelux B.V. has checked whether the following requirements are met:

• The devices are CE marked and there are EU declarations of conformity for the devices
• The manufacturers are known and, if necessary, an authorised representative has been designated in accordance with Article 11
• The devices shall be accompanied by a correct label (see “Explanation of packaging labelling” and instructions for use provided by the manufacturer corresponding to the information to be provided in Article 10(11)
• Where applicable, a UDI has been assigned by the manufacturer in accordance with Article 17

1. Since MegaGen Benelux B.V. is not only the importer but also the distributor and delivers directly to its customers, the details of the distributor (read importer) are attached to the tool by means of the packing slip with the correct contact details
2. MegaGen Benelux B.V. is aware that the devices are registered in the UDI Database in accordance with Article 29 in addition, MegaGen Benelux B.V. adds its own data in accordance with Article 31. The SRN number of MegaGen Benelux B.V. is NL-IM-000000807, this is the specific registration number of the EUDAMED
3. The storage and transport conditions of the organisation shall comply with the safety and performance requirements and with the conditions established by the manufacturer.
4. There shall be a system whereby the complaints received or not in accordance with the requirements of this Regulation concerning the devices originating from the healthcare provider, patient or user may be shared with the manufacturer and authorised representative. Go to the contact form at the bottom of this page.
5. The manufacturer and the authorised representative shall be informed if the importer considers that the devices are not in conformity with the Regulation. If the importer considers or has reason to believe that the device poses serious risks, the authorities and the CE Certification Body will also be informed, cooperation will also be provided to the above parties, if necessary
6. The manufacturer and the authorised representative shall be informed of suspected incidents, originating from healthcare providers, patients or users, relating to the devices that MegaGen Benelux B.V. has placed on the market.
7. MegaGen Benelux B.V. has a copy of the relevant EU Declarations of Conformity and its certificates
8. The importer may, at the request of the authorities, cooperate in actions taken to reduce the risks posed by the devices placed on the market by the importer or, if that is not possible, in addition, access to the devices may be granted.

Explanation of packaging labelling

There is a lot of information on our packaging, to make it clear for you what they are for and what they mean, you can view this image for more information. If something is not clear or you have further questions, please refer to the contact form.

Suppliers MegaGen Benelux

The suppliers of the products offered by MegaGen Benelux B.V. are, if this is mandatory, compliant for the MDR. These suppliers of MegaGen Benelux B.V. are:

• MegaGen Implant Co., Ltd.
• Medealis GmbH
• Acteon Group Ltd
• Medical bone
• EthOss Regeneration Ltd
• PURGO BIOLOGICS

If you would like more information about one of our suppliers, you can request it via the contact form at the bottom of this page.

Contact form

MegaGen Benelux about the MDR For questions related to the Medical Device Regulation or complaints, please fill in the contact form below. You will then be contacted to clarify the relevant topics.

• Question relates to (choose from: MDR, complaint, other question)
• You have a question about MDR, what exactly? (choose from: importer, distributor, labelling, suppliers/producers, other)
• Name
• Practice
• Phone number
• Email address
• Question