Make sure that repackaged products, modified packaging, and translated labels or manufacturer information meet the requirements of Article 16(3) of the Medical Device Regulation (MDR) through certification by SGS.
For whom is this certification relevant?
| For importers or distributors who make changes to the labeling, packaging, instructions for use, or information provided by the manufacturer. |  |
Regulatory compliance for importers and distributors
The Medical Device Regulation (MDR) is a challenge for importers and distributors of medical devices. Article 16 of the MDR defines precise requirements for companies that change the packaging or labeling of medical devices or provide translated manufacturer information.
Missing quality management processes in this area can result in legal risks, supply interruptions, or recalls. Certification by SGS ensures regulatory compliance in this area.
Article 16(3) of the MDR obligates distributors and importers to establish procedures in the quality management system to ensure that the translated information is correct and up to date. The tasks referred to in sections 2a and 2b – i.e., the provision and translation of product information as well as changes to the packaging or repackaging – must be carried out under conditions that ensure that the original product remains in its original form. At the same time, the packaging of the repackaged product must not be faulty, of inferior quality, or untidy. These requirements apply regardless of existing certifications according to ISO 13485, ISO 9001, or CE.
In addition, Article 16(4) requires that the manufacturer and the responsible authority of the country in which the device is to be placed on the market be informed at least 28 days before the relabeled or repackaged device is made available on the market. Section 4 also requires the submission of an attestation from the Notified Body (certificate) confirming that the quality management system of the distributor or importer fulfills the requirements set out in section 3.
As a Notified Body, we offer assessments as part of certification to confirm your compliance with the requirements of Article 16 of the MDR.
Why choose MDR Article 16 certification from SGS?
With the MDR Article 16 certification service from SGS, you get:
- Professional support from our experienced experts
- MDR Article 16 certification – currently without waiting time
- Verification that your repackaged products, packaging, labeling, and translations of manufacturer information provided comply with the requirements of Article 16(3) of the MDR
- Regulatory compliance for your supply chain through transparency and communication with the legal manufacturer of your medical devices
- Ensuring the free movement of goods on local EU markets
Why choose SGS?
We are the world’s leading service provider of testing, inspection, and certification services and are recognized as the international benchmark for quality and integrity. Our experts work in a global network to develop specialized solutions that make your business faster, easier, and more efficient.
What do I need to do to start the certification process with SGS?
For an initial, non-binding estimate of the certification costs, we need from you:
- A completed MD questionnaire with company information
- A list of the products or product types that you deal with as a retailer/importer
After checking the submitted documents, you will receive a non-binding offer and the application documents.
In the second step, you use these documents to submit an application for certification. Based on the information you provide and our review of your application, we will prepare a binding offer. After you have accepted the offer, we will plan the dates for your audit together with you.
However, as medical devices and manufacturers can differ widely, we cannot provide a reliable estimate of the lead time or costs of the certification project without a preliminary application review. Our MDR standard fee list provides an initial overview.
What documents are required?
For the second step, we need:
- Application forms completed by you
- Extracts from your quality management system
- Selected manufacturer information (e.g., QM manual, procedural instructions, and MDR certificates for the medical devices for which you are responsible in your role as importer/distributor)
Avoid legal uncertainties – obtain your MDR Article 16 certification now without waiting.
Downloads
- MDR Article 16 – Your Certification Process Explained (FPMDREG1016)
- Questionnaire for your non-binding initial inquiry about MDR Article 16 certification (FPMDREG1014)
- Guidance for notified bodies, distributors, and importers on certification activities in accordance with Article 16(4) of MDR + IVDR: MDCG 2021-23
- Q&A on repackaging & relabeling activities under Article 16 of MDR + IVDR: MDCG 2021-26
- Regulation (EU) 2017/745 on medical devices
- SGS certification for medical devices
- SGS Fimko OY Scope
- MDR Standard Fees List
Contact
Armin Hudetz
t: +49 89 787 475-133
E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.
Customer Service Team
t: +49 89 787 475-222
E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.