CE Mark Medical Device Certification Consultant

EU MDR – Medical Device Regulation

MDD和MDR的差异

The MDR i.e. Medical Device Regulation replacing MDD regulation came into force on 26thMay 2017 and is expected to run effective from 26thMay 2021. Some of the important difference in both regulations can be seen below:

Areas	MDD	MDR
Device classification rules	18	22
No of Annexes	12	17
No of articles	23	123
Regulation/ Directive	Directive; legislative rules	Regulation; directly applicable to all EU member states
UDI要求/植入卡	不是强制性的	Mandatory
PMS requirements	No PSUR requirement	Additional need for PMS Plan, PMS report and PSUR (for class 2 and 3)
PMCF requirements	Not deemed necessary	PMCF plan with detailed description required
Vigilance Reporting requirements	Manufacturers have to report: serious adverse events/device recalls	Manufacturers have to report: Serious Incidents Field Safety Corrective Actions Trend Reporting Timelines are mentioned clearly for all reporting events
Economic Operators/Importers	不需要	必需的
PRRC(人负责监管合规)	不需要	必需的
Database for storage of regulatory information	Not applicable	Mandatory
Clinical Evaluation	Updates were required annually for high risk devices and 2-5 years for low-medium risk devices depending upon nature of the device	Additional requirement of SSCP document for class 3 and class 2b implantable. All class 3 and class 2b implants must be updated annually and rest low risk-medium risk 2-5 years. Clinical Investigation mandatory for class 2b Implants and class 3 as per chapter VI unless justified.
AIMD inclusion	没有目标	AIMD included
DOC	Declaration of conformity has to be drawn and CE mark should be added to product	Declaration of conformity has to be drawn and CE mark should be added to the product along with detailed information to be included as per Annex V of MDR. This will be made available in the official language needed by Member States

MDD to New MDR Classification of Medical Devices

医疗设备的MDR分类的先决条件基本上等同于当前医疗设备指令（MDD）中的先决条件。欧盟MDR正在摇晃医疗设备行业，订单规则尚未完美无缺。MDR决定该设备的一致性评估课程。虽然该订单主要担心制造商，但如果设备属于IIA，IIB或III类，则对通知机构有建议。

Before medical devices manufacturers can lawfully CE stamp their products in Europe, they should consent to the fitting medical devices order or guideline set out by the EU Commission. It is crucially critical to know the right medical device classification for your product before CE marking your devices.The CE medical deviceclassificationimpacts the administrative prerequisites for your devices, just as the endorsement course and its related expenses.

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The channel to EU MDR compliance

EU MDR compliance for CE Mark Medical Device.

The main basic understanding of the law, the difficulties, with under two years until the check runs out, it might amaze you to discover that 78% of medicinal device organizations don’t yet trust that they have adequate comprehension of the EU MDR enactment.

A large portion of the obstacles organizations are confronting begin here: At an abnormal state, the industry must acknowledge the way that the take-off and translation of any broad-based control will contain components of “hazy area”. The voyage to consistency won’t occur without any forethought and slip-ups will be made by any association endeavouring to agree to the considerable rundown of MDR necessities.

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Medical Device Regulation for CE

MDR也称为医疗装置调节。条例一词是指法律立即适用和强制执行。当前的MDD指令已由MDR取代，并将自2021年5月生效。

MDR的内容在以下各章中包括123篇文章：

• 第一章 - 范围和定义
• Chapter II- CE marking, Economic Operators and Reprocessing
• Chapter III- Identification and Traceability of Devices
• 第四章通知机构
• Chapter V- Classification and Conformity Assessment
• Chapter VI- Clinical Evaluation and Investigation
• 第vii章PMS，警惕和市场监视
• 成员国，医疗设备协调小组，专家实验室，专家小组和设备登记册之间的第二章合作
• Chapter IX- Confidentiality, Data Protection, Funding Penalties
• Chapter X- Final Provisions

Also Read :EU MDR checklist – Effects on Medical Devices

EU IVDR – InVitro Diagnostics Regulation

IVDR Classification – IVD CE mark

The New IVDR Classification necessary changes are compared with the previous In Vitro Diagnostics Directives structure. Before the arrangement of IVDD was a basic and inflexible rundown – based framework that took into account diverse choice by various EU states.

The IVDR (In Vitro Diagnostics Regulation) is the new regulatory reason for placing on the market, making accessible and placing into servicein-vitro diagnostics medical devices在欧洲市场。它将supplant the EU’s present order on in-vitro diagnostics medical devices (98/79/EC). As a European guideline, it will be compelling in all EU member states. 

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IVDR Technical Documentation

The set of IVDR technical documentation is evaluated per device category. IVDR is the new regulatory basis for placing in the market, making it available and putting it into service in-vitro diagnostics medical devices in the European market. In-vitro diagnostics (IVD) is a system where medical devices and reagents are utilized to analyze examples, for example, blood, urine, instruments, tissues, and other body liquids which are derived from the human body to recognize sicknesses, conditions and contaminations.

IVD中合并的巨大创新部分结合了聚合酶链响应（PCR），微阵列程序和测序创新和质谱法，可用于测试布置。欧洲工会在体外诊断调节（IVDR）2017/746），取代了当前的体外诊断指令（IVDD 98/79/EC），提出了基于风险的IVD医疗分组，但仍有另一项必要的技术文档。

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Certification Process

We help you understand and meet the regulation to ensure your product completes the CE Marking process efficiently and successfully. And answer the questions. How to get ce mark for medical device ? and CE Mark Medical Device certification process.

Before the CE Mark may be affixed to a medical device and legally sold within the European Union, the manufacturer or exporter must complete the following:

• Prepare Technical Documentation (Technical File) to show the product’s compliance with applicable essential requirements and conformity assessment procedures of the applicable device directive
• Register their device with the appropriate Competent Authorities
• Receive a device-specific CE Certificate from a Notified Body (Class I devices do not require a certificate from a Notified Body)

1. Determine your certification process based on your device class
2. Fulfill the essential requirements – Ensure that your medical device fulfills the essential requirements in Annex I of the Medical Device Directive.
3. Establish a monitoring system – As a manufacturer, you are required to monitor your products once they are on the market, in case accidents involving your products occur.
4. 建立事故报告系统 - 如果发生任何产品的事故或接近犯，您有义务向当局报告。
5. Issue a Declaration of Conformity
6. Save the documentation for five years – The new revision of the MDD requires that records for implantable devices be kept for 15 years. Declaration of conformity, technical documentation, reports, and certificates from the Notified Body etc. must be kept for at least five years after the product has been taken out of production.
7. Register with the appropriate authorities in Europe.

CE Mark Medical Device classification is based on risk. Medical Device Classes are Class I,IIa,IIb.Manufacturer can check CE marked medical deviceslist.

Certification Process for class I

脚步	Non sterile non measuring	Sterile and measuring
1	确定适用的欧盟指令	确定适用的欧盟指令
2	识别分类,类和规则	识别分类,类和规则
3	Implement PMS procedure	Implement QMS system
4	Prepare Technical File	Prepare Technical File
5	Appoint an EU authorised representative	Appoint an EU authorised representative
6	Not applicable	Choosing Notified Body
7	No Audit	QMS and Technical File notified Body Audit
8	Self-Certification	CE mark and QMS certification by NB
9	Declaration of Conformity (DOC) and Affix CE Mark	Declaration of Conformity (DOC) and Affix CE mark
10	Updates to CER and PMS to be done	NB审计续约

Certification Process for Class IIa

脚步	Activity
1	确定适用的欧盟指令
2	识别分类,类和规则
3	Implement QMS system
4	Prepare Technical File
5	Appoint an EU authorised representative
6	Choosing Notified Body
7	QMS and Technical File notified Body Audit
8	CE mark and QMS certification by NB
9	Declaration of Conformity (DOC) and Affix CE mark
10	NB审计续约

Certification Process for Class IIb

脚步	Activity
1	确定适用的欧盟指令
2	识别分类,类和规则
3	Implement QMS system
4	Prepare Technical File
4.1	Conduct Clinical investigation studies where applicable
5	Appoint an EU authorised representative
6	Choosing Notified Body
7	QMS and Technical File notified Body Audit
8	CE mark and QMS certification by NB
9	Declaration of Conformity (DOC) and Affix CE mark
10	NB审计续约

Technical file for CE

Technical file documentation helps demonstrate that the device is compliant with the European Directives requirements and all the processes of the manufacturing processes. Thus, it forms one of the gateways for obtaining a CE mark. The typical content of a Technical File consists of the following:

• A general description of the product, including any variants planned and its intended use(s)
• 设计图，设想的制造方法和组件，子组件，电路等的图表等。
• The descriptions and explanations necessary to understand the drawings and diagrams and the operations of the product
• The results of the risk analysis and a list of the standards
• In the case of products placed on the market in a sterile condition, description of the methods used and the validation report
• The results of the design calculations and of the inspections carried out, etc.; if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer
• 设计和制造信息
• Safety and Performance requirements
• Product Verification and Validation
• Pre-clinical evaluation
• Clinical Evaluation
• PMS plan and report, PMCF plan and reports
• The label and instructions for use
• 所有测试报告，即设备/性能/存储/运输/过程/无菌/灭菌/生物相容性等。

The technical file is a comprehensive collection of information and data that details everything about your medical device. If you manufacture a Class I device, a less complex CE Mark Technical File may be required. In the case of Class IIa, IIb and Class III devices, a more complex CE Technical File or Design Dossier must be prepared. EU Technical File construction is subject to review by a Notified Body if the medical device is Class I with measuring or sterile function, Class IIa, IIb, and III (Design Dossier). CE Marking technical file or dossier incorporates definite data about the design.

A technical file includes drawings, reports, review reports, specifications, meeting minutes, labels, instructions for use, softwaresource code etc.medical device regulationEUAnnexure 2contains an overview of the contents and structure of a technical file. Technical file is a set of documents that describes a product and can prove that the product was designed according to the requirements of the Quality Management System.

EU enforcement authorities may demand a copy of the technical file for many years after the last product was made. Medical Device Regulation (MDR) manufacturers need to maintain a MDR technical documentation as an evidence of conformity with the relevant legislation. Customers usually do not have the access to the technical file. A technical file is usually based on a document archive system that ensures longevity of documents and can either be on paper or in electronic files.

PRRC(人负责监管合规)

The new European Commission’s guidance on persons responsible for regulatory compliance (PRRC) explains that manufacturers, Authorized Representatives and micro and small manufacturers must designate at least one staff member responsible for ensuring compliance to the MDR and/or IVDR as appropriate according to Article 15 of the Regulation. PRRC qualifications are specific for each of these three operators. A manufacturer’s PRRC must have either a formal qualification (university degree) in addition to a minimum of one year’s professional experience in medical device regulatory affairs or quality management; or four years of experience in regulatory affairs or quality management pertaining to medical devices.

• PRRC qualifications obtained outside the European Union should be recognized by an EU Member State as equivalent to an EU qualification;
• Organizations that have more than one legal manufacturer must designate a PRRC for each of its manufacturing entities;
• European regulators will generally assume that manufacturers based outside the EU will have PRRCs located outside the EU, as well.
• Micro and small manufacturerswill have the option to subcontract their PRRC functions to third parties that meet qualifications laid out for manufacturer PRRCs in Article 15 of the MDR.
• European Authorized Representativesmay also outsource their PRRC responsibilities to third parties, provided their subcontractors meet stated qualifications.
• Finally, the guidance explicitly forbids a single individual from serving as PRRC for both an Authorized Representative and a manufacturer based outside the EU.

对于CE Mark Medical设备，法规中有一个明确的愿望，即授权代表们增加了额外的审查水平，并确保对设备制造的监督和控制以及相关的后市场监视和警惕活动充分影响指导。

Testing Requirements For CE Marking:

Testing of devices is crucial in obtaining a CE mark as all testing results signify that the product meets the standard requirements and is effective to use. There are different categories of testing required behind a medical device/process compliance. They can be but not limited to;

• Bio-compatibility Testing
• Sterilization Validation Testing
• Electric Safety Testing
• Performance Bench Testing
• Verification and Validation Testing
• Software and Hardware testing
• Functional Testing
• 运输和存储验证测试

识别测试要求的方法：

• Identify competitor products and testing done on the competitor device
• List all the applicable standards and identify which test method applies to your device

Along with the chapters and articles to demonstrate the inclusion of the MDR; the MDR also proposes 17 ANNEXES which collide in making up the technical file for CE marking. They are as follows:

• Annex I- General safety and performance requirements
• Annex II- Technical Documentation
• Annex III- Technical Documentation on PMS
• Annex IV- EU Declaration of Conformity
• Annex V- CE Marking of Conformity
• Annex VI- UDI DI
• 附件vii - 由通知机构满足
• Annex VIII- Classification Criteria
• Annex IX- Conformity Assessment (QMS and Technical Documentation)
• Annex X- Conformity Assessment – Type Examination
• 附件Xi-符合度评估 - 产品合规验证
• Annex XII- Procedure for Custom-made Devices
• Annex XIII- Certificates issued by a Notified Body
• Annex XIV- Clinical Evaluation and Post-market clinical follow-up
• Annex XV- Clinical Investigations
• 没有预期的医疗目的附件XVI-产品
• Annex XVII- Correlation Table 90/385, 93/42 and Regulation

All the major changes affecting MDD to MDR transition includes:

• Additional classification rules have been included than those that were present in MDD
• Notified Bodies roles and responsibilities have become stringent and unannounced audit can be taken place under MDR
• Proving Clinical Evaluation and evidence has additional requirements of conducting clinical investigation for high risk devices than just proving equivalence. Safety and Performance data, post market clinical follow up studies essential.
• High scrutiny for PMS has been stated and demanded as a part of MDR, EUDAMED is going to take seat as a part of MDR where PMS related documentations are mandated to be uploaded and co-ordinated. Trend reporting and other reporting requirements have been introduced via MEDDEV guidelines for MDR implementation
• Traceability and transparency mediums have been mandated via UDI DI requirements for all types of devices; as well as implant cards for implants. All operators will be registered centrally.
• Governance includes central committee i.e. MDCG, expert panels, expert labs etc

ISO 13485 and its requirement:

CE marking is accompanied with ISO 13485 requirement as a part of achieving compliance with European requirements and subsequently for Notified Body audits. Thus, it binds as an essential part of the CE marking process. The major requirements in establishing an ISO 13485 QMS system are as follows:

Creating and maintaining departmental Standard Operating Procedures (SOPs) and their respective formats as seen below:

• Document Control
• Records Control
• Human Resources and Administration
• Marketing
• 管理控制
• Production and Process Control
• Design Control
• Maintenance Control
• Purchase Control
• Microbiology Control
• 商店
• Quality Assurance
• Quality Control
• Quality Manual

Also read:Better Insights For ISO 13485 2016 Validation Requirements

上述所有控件包括ISO 13485中提到的不同条款。建立所有SOP的直接步骤是创建各个SOP的所有记录，以证明该设施和ISO 13485要求的有效实施。必须确定机器和设备的验证和验证。通知的身体审计受到条款，并进行有效的检查，以分析公司是否满足所有要求。

Countries the certificate is Valid

Globally, every country has their own regulatory body under which the device is regulated and permitted for trade within the country and which assures that the device fulfils the regulatory requirements of that particular country.Teamof Operon gives insightsonCE认证for medical devices inIndia.Likewise, a CE marking certificate is mandatory for sale in all European Union countries. There are 27 European Union countries as listed below:

1. 奥地利，
2. Belgium,
3. Bulgaria,
4. Croatia,
5. Republic of Cyprus,
6. Czech Republic,
7. 丹麦，
8. Estonia,
9. Finland,
10. France,
11. Germany,
12. Greece,
13. Hungary,
14. Ireland,
15. Italy,
16. 拉脱维亚，
17. Lithuania,
18. Luxembourg,
19. 马耳他，
20. Netherlands,
21. 波兰，
22. Portugal,
23. Romania,
24. Slovakia,
25. Slovenia,
26. Spain
27. Sweden

Along with the EU countries; countries i.e. Iceland, Liechtenstein and Norway together form the EEA (European Economic Area) and United Kingdom which together form a part of the single EU market.

我们是医疗设备的领先医疗设备CE标记认证顾问，用于一次性设备188bet金搏宝滚球的一次性植入物制造商，医疗一次性注射器制造商，手术仪器制造商，骨科植入物和仪器制造商，实验室设备制造商，消毒设备和配件制造商，医学成像系统制造商。

How to register medical devices in Europe?

The process for the approval of Medical Device in Europe is

Classification of the Medical Devices based on the MDR guidelines.

• Procuring CE Mark Certificate.
• For all Classe Is II and III except Class I(non sterile, non measuring) implement Quality Management System (QMS) accordance to Annex II or V of the MDD
  大多数公司申请ISO 13458标准以实现QMS合规性。
• For Class I (non sterile, non measuring) QMS is not formally required. However a PMS procedure is required, though not audited by Notified Bodies.
  Medical Device Directives (MDD) are the guidelines for CE Marking which after 2020 will be replaced with Medical Device Regulation. (MDR)

What are EU Directives?

An EU Directive is a form of legislation that sets out requirements your products must meet in order to sell them into Europe. The European Union introduced a series of measures to simplify the movement of goods throughout the European Union (EU) and the European Free Trade Area (EFTA). Some of these measures are known as New Approach Directives. New Approach Directives provide controls on product design and above all, seek to harmonize product safety requirements across Europe.

产品的指令覆盖非常广泛areas including construction products, personal protective equipment and pressure equipment. Their primary objective is to ensure that the products are well designed, and safe for the user. Throughout Europe, where a New Approach Directive is in force, it is necessary for the manufacturer to CE mark their product. CE marking requirements vary from Directive to Directive, and even within Directives. For More information visit :European Commission – Medical Device