CE Marking for Medical Devices under MDR

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 became fully applicable on May 26, 2021. From that moment on, the MDR applies to all medical devices placed on the market in the EEA.

Manufacturers with legacy devices holding Directives certificates issued from 25 May 2017 that were still valid on 26 May 2021 may continue to place such devices on the market beyond 26 May 2024, provided that the conditions defined under Regulation (EU) 2023/607 are fulfilled.

Under the amended transitional provisions, legacy devices may remain on the market until the following dates, depending on their classification:

• Class III and Class IIb implantable devices: until 31 December 2027.
• Class IIa, Class IIb (non-implantable), and Class I devices requiring Notified Body involvement: until 31 December 2028.
• Custom-made Class III implantable devices: until 26 May 2026.

To benefit from these extended transition timelines, the following conditions must be met:

• No later than 26 May 2024, manufacturers must have put in place an MDR-compliant quality management system and submitted a formal application to a Notified Body for MDR conformity assessment.
• No later than 26 September 2024, a formal written agreement with a Notified Body must be signed for the relevant devices, and appropriate surveillance must be ensured.
• In addition, legacy devices must continue to comply with the applicable Directive requirements, must not undergo significant changes in design or intended purpose, and must not present an unacceptable risk to health and safety.

The previously applicable “sell-off” deadline has been removed.

Products without an intended medical purpose under MDR Annex XVI (Common Specifications)

The MDR also covers certain groups of products without an intended medical purpose that present a similar risk profile to medical devices. These products are listed in Annex XVI (e.g. dermal fillers, laser hair removal equipment, coloured contact lenses).
The applicable technical requirements for these products are defined in the Common Specifications (CS) established by Commission Implementing Regulation (EU) 2022/2346, which have applied since 22 June 2023.

For Annex XVI products, the applicable transition periods depend on the product status and the conformity assessment route:

• For legacy products covered by a valid MDD certificate, the extended MDR transitional provisions under Article 120 apply (until 31 December 2027 or 31 December 2028, depending on the risk class).
• For products requiring Notified Body involvement without a clinical investigation, the transition period may extend until 31 December 2028.
• For products requiring a clinical investigation, the transition period may extend until 31 December 2029, subject to specific conditions.

During the transitional period, products must:

• have been lawfully placed on the market before 22 June 2023.
• not undergo significant changes in design or intended purpose.
• continue to comply with applicable safety and performance requirements.

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), Kiwa Assurance BV (Netherlands) (NB 1912) and Kiwa Belgelenddirme Hizmetleri (Turkey) (NB 1984) 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 Assurance BV 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 Belgelenddirme Hizmetleri, designated by the Turkish Ministry of Health, provides worldwide conformity assessment services for an almost full scope of designation. The scope details are reported 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.