MDR certification and approval

Manufacturers need to apply for an applicable conformity assessment procedure based on their product classification. If you pass the assessment and your product meets MDR requirements, your device will receive a CE mark. This CE mark allows your device to be sold in Europe.

Procedure for EU certifications of conformity

The conformity assessment procedure to be followed to obtain the EU Conformity Certificate differs based on the risk class of the medical device according to art. 52 of the MDR.

For Class I sterile devices (Is) or with measurement function (Im) or reusable surgical instruments (Ir), IIa, IIb and III (including custom implantables), the intervention of the Notified Body is always required.

Please contact us via the contact button or sent an email to medical@kiwa.com to discuss which procedure applies to your product.

What is the MDR Regulation (EU) 2017/745?

MDR stands for Medical Device Regulation – Regulation EU 2017/745, with corrigendum and amendments to replace the previous directives: Directive 90/385/EEC on active implantable devices and directive 93/42/EEC on medical devices.

The medical device regulation aims to ensure the safety, quality, and performance of medical devices, as well as to protect the health and rights of patients and users

MDR timeline and transition period

The MDR was officially published on May 5, 2017 and entered into force on May 25, 2017. As subsequently established by Regulation (EU) 2020/561, it found its full application on May 26, 2021. From that moment on, the MDR became applicable to all medical devices sold in the EEA.

Manufacturers with legacy devices that intend to transition to the MDR and holding Directives certificates issued from 25 May 2017, that were still valid on 26 May 2021 and that have expired before 20 March 2023 are allowed to continue placing on the market legacy devices and benefit from the extended transition timelines until 26 May 2024 if one of the following conditions is fulfilled:

  • The manufacturer had signed a formal written agreement with a Notified Body for the Regulation prior to the expiry of those Directive certificates. OR
  • A derogation/exemption has been granted by a Competent Authority under either Article 59(1) or Article 97(1) of the MDR before 20 March 2023.
    But the manufacturer can also benefit from the longer validity of Directive certificates for legacy devices if the following conditions are met:
  • No later than 26 May 2024, manufacturers have put in place an MDR compliant quality management system and have lodged a formal application with a Notified Body for MDR Conformity Assessment .
  • No later than 26 September 2024, a formal agreement with a Notified Body has been signed in respect of the device covered by the expired certificate and appropriate surveillance must be guaranteed for legacy devices.

From MDD to MDR

With the arrival of the MDR, the EU legislation there are a number of changes to get your medical device compliance.

Key changes include:

  • A greater emphasis on a life-cycle approach to safety, supported by clinical data (Art. 61);
  • New rules for classification of devices with more rigorous and precise criteria (Annex VIII);
  • New articles define specific obligations for economic operators such as agents, importers, and distributors. 11, 13 and 14);
  • A need for financial coverage (art. 10) and a designated person who is responsible for compliance (art. 15) for the manufacturer;
  • The specific documents such as a summary of safety and clinical performance;
  • Summary of safety and clinical performance SSCP (art. 32) for implantable and class III devices, periodic safety update report (PSUR, art. 86) for class IIa, IIb and III devices and the card for patients with implantable devices (art. 18);
  • The inclusion of products that do not have a medical purpose such as products with aesthetic purposes (Annex XVI);
  • A new system of unique identification of devices (UDI, art.27) for the traceability and effectiveness of activities related to post-marketing safety and new European Database (EUDAMED, art. 33). EUDAMED will play a central role in increasing both the quantity, quality and availability of data;
  • Strengthening of external consultation procedures with Competent Authorities for medical devices. These procedures are based on substances, drugs and animal tissues and introduction of a new clinical evaluation consultation for some class IIb, implantable and class III devices.

Kiwa Notified Body for MDR

Within the Kiwa group, Kiwa Cermet Italia (NB 0476) and Kiwa Dare (Netherlands) (NB 1912) have been designated as Notified bodies for the MDR.

Kiwa Cermet Italia successfully achieved designation as a Notified Body by the Italian Ministry of Health and the European Commission for Conformity Assessment activities according to the Medical Device Regulation (EU) 2017/745 (MDR). The designation is included in the Nando Database of the European Commission. Kiwa Cermet Italia can provide assessment services worldwide thanks to its many experts in various countries.

Kiwa Dare is appointed by the Dutch Ministry of Health, Welfare and Sport (VWS) as Notified Body for the Medical Devices Regulation (EU) 2017/745 (MDR). The designation is included in the Nando Database of the European Commission.

Kiwa operates independently and impartially to assess conformity, ensuring its experts are competent, professional, and have integrity. Furthermore, Kiwa has internal procedures in place to ensure absolute confidentiality of information received during the assessment activities.

Through the association to Team NB (European Association of Notified Bodies in the field of medical devices), Kiwa Medical actively participates in the technical working tables for the development of the main documents and guidelines of the medical sector and has quick access to all updated information and new approaches applicable to medical devices.

Prices

You can find an overview of our standard fees for conformity assessment activities over here.
If you have questions about CE Marking for Medical Devices under the MDR, email medical@kiwa.com for assistance.