MENU

MDR(Medical Device Regulation)

The new Medical Device Regulation (MDR EU)

의료기기 인증 MDR(Medical Device Regulation)은 2021년 5월 26일부로 EU의 의료기기 
지침 (MDD, 93/42/EEC) 및 지침 90/385/EEC(활성 이식형 의료기기-AIMDD)을 대체하게 
되었습니다.
의료기기 인증 MDR은 EU의 기존 지침과 몇 가지 중요한 차이가 있습니다. 
의료기기 인증 MDR에서 주요 변경사항은 하기와 같습니다.

MDR Zertifizierung CE Kennzeichen MDR Zertifizierung CE Kennzeichen MDR Zertifizierung CE Kennzeichen MDR Zertifizierung CE Kennzeichen

[의료기기 인증 MDR 주 변경 사항]

  • 규제 준수 책임자(PRRC) 지정 
  • 의료기기 인증 고유 식별 코드(UDI, Unique Device Identification) 시스템 적용
  • 특정 고위험 제품/기기에 대한 요구사항 강화
  • NB 지정기준 및 감독 강화
  • 특정 미용 장치 포함(컬러렌즈, 필러, 안티에이징 기기)
  • 유럽 중앙 데이터베이스 (EUDAMED), UDI, SRN 확립
  • 임플란트 카드 도입
  • 임상 평가 및 검증 요구사항 강화
  • 시판 후 감시 요구사항 강화 (PMS, PSUR, SSCP 등)

TÜV NORD는 세계적으로 공인받은 인증기관으로, 다양한 기업과 의료기기 지침 93/42/EEC (MDD) 및 능동형 이식 
의료기기 지침 90/385/EEC (AIMDD)의 준수 여부를 인증했습니다.

TÜV NORD는 전문 엔지니어들과 함께 다수의 프로젝트를 통해 의료기기 분야의 높은 역량과 경쟁력을 갖추고 있습니다.

2024년 5월 이후 유효한 MDR 인증이 없는 제품은 시장 출시가불가합니다.
전환 기간이 끝날 무렵에 인증 계획을 세우기보다 지금부터 인증 기관과 협력하여 조언을 받고 현실적인 계획을 수립해야 
합니다.

TÜV NORD는 프로세스를 준수하여 전문적이고 체계적인 서비스를 제공합니다.

The most important changes for medical Devices manufacturers

Extended scope

The new Medical Devices Regulation no longer only applies to traditional medical Devices, but also to products “without an intended medical purpose” (Annex XVI – List of product groups in this category).

Among others, products for “body modification” and “beautification” are included, in other words, products which are used by the consumer without a specific medical purpose stated by the manufacturer. Products for liposuction, hair removal and skin resurfacing are also affected.

MDR source:
Article 1: Subject matter and scope

Reclassification of products

In order to keep pace with technical developments, the classification rules have now been changed. For many manufacturers, this means that their products may be classified in a higher class.

MDR source:
Article 51: Classification

Availability of a qualified person

Manufacturers must appoint at least one person who is responsible for regulatory compliance (PRRC). Article 15 of the Medical Devices Regulation (MDR) describes the qualification profile and the tasks of the PRRC in detail.

MDR source:
Article 15: Person responsible for regulatory compliance

Strict post-market surveillance

The responsibility of the manufacturer with regard to post-market surveillance has been newly defined. The Medical Devices Regulation requires ongoing and systematic documentation which also fulfils the new requirements for Post Market Clinical Follow-Up (PMCF).

MDR-Source:
Article 83-100: Post-market surveillance

Systematic clinical evaluation of highclass medical devices

The MDR requires a clinical evaluation of existing clinical studies and publications with regard to safe and effective use of the medical Devices. These documents are assessed by<s> </s>our clinical experts within the framework of the conformity assessment procedure.

MDR source:
Article 61: Clinical evaluation
Article 62-80: Clinical investigation

No grandfathering for products with existing certification

The Medical Devices Regulation does not provide a right of continuance for products with existing certification. This means that medical Devices which are already approved at the present time have to be newly assessed and certified. Medical Devices approved under the MDD may only be placed on the market up to 26 May 2024.

Common specifications

In addition to “harmonised standards” there are now so-called “common specifications (CS)” for design and manufacture of medical Devices (MDR Art. 2,71). These contain detailed information on technical specifications, necessary processes, and evidences to be provided for certain product categories in order to demonstrate compliance with the given safety and performance requirements.  However, their use is voluntary if it can be proven that the solutions adopted ensure a level of safety and performance that are at least equivalent to the state of the art.

MDR Source:
Article 9: Common specifications

Stricter clinical evidence for high risk medical Devices

Manufacturers of Class III medical Devices have to draw up and publish regular reports regarding their clinical performance (“Summary of safety and clinical performance”, SSCP). This is intended to ensure that members of the public who make use of the Devices can access up to date information about them.  

MDR source:
Article 55: Mechanism for scrutiny of conformity assessments
Article 61: Clinical evaluation
Article 62-80: Clinical investigations

System for unique Devices identification (UDI system)

In order to allow the identification and facilitate the traceability of Devices, the Medical Devices Regulation has introduced a system for unique Devices identification (Unique Devices identifier - UDI).

All medical Devices must be provided with a UDI Devices identifier (‘UDI-DI’) specific to a manufacturer and a Device. Following a transitional period dependent on the risk class, these identifiers have to be placed on the label of the Devices or on its packaging so as to be easily readable by man and machine.

Installation of the unique Devices identification system is mandatory for all Devices as from 26 May 2021. However, the label only has to be attached to the Devices or packaging at the end of the transitional period specified for the respective risk class, as shown below:

26 May 2021:
Implantable Devices and Class III Devices

26 May 2023:
Class IIa and IIb Devices

26 May 2025:
Class I Devices

If the products can be re-used, the UID-DI has to be placed directly on the product no later than 2 years after the above deadlines, for example by means of laser engraving (direct marking).

MDR source:
Article 27

 

MDR certification procedure

Procedure for a MDR certification Procedure for a MDR certification Procedure for a MDR certification Procedure for a MDR certification

FAQs on the MDR – Medical Devices Regulation

What is the Medical Devices Regulation?

The Medical Devices Regulation, officially referred to as (EU)2017/745, is a harmonised regulation. Manufacturers who fulfil the requirements of the regulation are permitted to label their Devices with the CE mark and can sell them in all EU member states and EFTA states without the need for further certification or approval.

When did the MDR enter into force?

The Medical Devices Regulation replaced the previous European Directives on 26.05.2021. This means that it is the only set of rules which governs the placement of medical Devices on the market in Europe.  

An exception is made for a few Devices where manufacturers still have valid certificates of conformity (so-called “legacy Devices”). These Devices may be placed on the market until 26.05.2024, on condition that they do not undergo any “significant changes”.

Where can I find more information?

European Commission / Nando (TÜV NORD CERT Notified Body) und Designation scope 

ZLG  (Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten)

MDCG (Guidance - MDCG endorsed documents and other guidance)

EUDAMED (European Database on Medical Devices)

 

What is covered by the Medical Devices Regulation?

The Medical Devices Regulation lays down the requirements for the safety and performance of medical Devices and the requirements for the quality systems which govern their development, manufacture and placement on the market.

What are the reasons behind the new Medical Devices Regulation?

Over almost 25 years of harmonised requirements for medical Devices, technology and the approach taken by courts of law developed and changed. In the light of this it became necessary to reconsider existing European Directives regarding medical Devices, active implantable Devices and in-vitro diagnostics.  

The creation of the new Medical Devices Regulation (MDR) was also triggered by the breast implant scandal. The new legislation is intended to prevent re-occurrence of similar events in future.

The new regulation has the advantage that it does not need to be implemented in the individual member states through transposition into national law. This allows uniform interpretation of the requirements and means that the regulation can be used directly by manufacturers in its current published form.

Related News

TÜV NORD Korea, MDR 의료기기 인증 세미나 개최

TÜV NORD Korea 는 KMDICA (한국의료기기합동조합)과 의료기기 인증 세미나를 개최하였습니다.
Read more

TÜV NORD Korea, 한국로봇산업진흥원 지정시험소 자격 지원

TÜV NORD Korea 는 KIRIA (한국로봇산업진흥원)에 지정시험소 자격을 부여하였습니다.
Read more