Obelis Training Courses

in 來自Obelis的CE標示服務


Obelis offers a range of dedicated training sessions conducted by industry experts designed to make your organization familiar with the EU legislation surrounding medical devices.

The content of our training courses can be customized according to your needs. This makes our trainings suitable for those new to the EU market as well as regulatory and/or quality staff seeking to increase their regulatory expertise.

Our training courses can be attended online or performed on-site.


In light of the new EU regulations, we proudly present Obelis MDR & IVDR Training Program. The training courses are designed to prepare manufacturers for compliance with the EU MDR & IVDR and cover among others the below topics:

  1. MDR & IVDR Transition Highlights & Strategies;
  2. New Essential Requirements & Conformity Assessment Routes;
  3. Technical File Requirements – Gap Analysis from Directive to Regulation;
  5. New Requirements for Economic Operators;


  • MDR/IVDR ON-SITE TRAINING: This training aims to provide in-depth technical and practical knowledge about the MDR & IVDR. During a 1 or 2-day training course, industry experts focus on the operational impact of the new regulation(s) and offer tools to determine the best compliance strategy for your business


  • MDR/IVDR ONLINE TRAINING: This training summarizes the most relevant topics of the MDR & IVDR. During 2 hours, we highlight the important changes of the new legislation with a Q&A session.


Please click here for a quotation or click below on the on-site training service request form to get a tailored offer.

Training Request Form

Services for Device Registration in Bulgaria

in 來自Obelis的CE標示服務


Placing your medical device into the European market is contingent upon your compliance with the Medical Device Directive (93/42/EEC). While this Directive is a law to all 28 member states within the European Union, each member state has its own way of implementing the Directive within their country, essentially adding regulations to the Directive and creating Local Legislation.

An example of such local implementation of the Directive is present in Bulgaria. As a non-EU manufacturer of medical devices, you are required to use a European (legal) representative to register your medical device with the Bulgarian database. Non-Bulgarian manufacturers that are based in European Union are also required to complete this registration themselves or appoint a legally-mandated representative to register for them.

Registration Process

In accordance with the Law on Medical Devices, adopted by the Bulgarian Parliament during its session on June 12, 2007, and as promulgated in the Bulgarian State Gazette No. 46, some categories of medical devices must be registered with the Bulgarian Drug Agency (BDA). This registration is mandatory for medical devices that enter the EU internal market through, or if they are being manufactured in, the territory of Bulgaria.

The categories of medical devices that are affected by this obligatory registration are:

  • Class I Medical Devices;
  • Class Is and Class Im Medical Devices;
  • Custom-made Medical Devices;
  • Systems and procedure packs;
  • Systems and procedure packs subjected to sterilization before use;
  • Medical Devices subjected to sterilization before use;
  • In Vitro Diagnostic Devices

The manufacturers of Medical Devices that are classes IIa IIb and III, and established outside Bulgaria, are exempted from this requirement.

Obelis, as a professional European Authorized Representative, can perform the registration procedure on behalf of Non-EU manufacturers. A registration application form is provided by BDA and the file is submitted as a hard copy via post or courier.

Third party commercial entities, like distributors, should not register your medical devices for several reasons, a few of which are:

1.By allowing a third party commercial entity to register in your behalf, the manufacturer relinquishes an essential part of his control over his medical device in Bulgaria;

2.If you decided to end the relationship with your commercial distributor at any point, you would be required to take your medical device completely off the market until you could re-register that medical device within Bulgaria for a second (third, fourth, etc.) time;

3.Your third party commercial entity will expect exclusivity, limiting the open distribution of your medical device.


1.For the benefit of non-EU manufacturer, the distributor SHOULD NOT have part in any regulatory affairs

2.The manufacturer should register their medical devices with the Bulgarian database through his appointed Authorized Representative

Local Legislations, such as this one, are growing rapidly in Europe (Italy, Portugal, France, Greece, Latvia and Croatia) and strengthen the need for a professional European Authorized Representative present at any time.





in 來自Obelis的CE標示服務



  • 欧盟授权代表服务(EC Rep)
  • 第一类器材的上市前通告,以及初步临床试验通告。
  • 上市后顾问服务
  • CE标示服务
  • 自由销售证书服务
  • CE证书注册服务
  • GMDN代码搜索服务




| Home | Contact Us | Get a Quote |


in 來自Obelis的CE標示服務

我们的专业欧盟授权代表服务,以确保您符合MDD 93/42/ECC、IVDD 98/79/EC以及AIMDD 90/385/EEC为目标:

「当将器材以其名义上市的制造商于加盟国内没有注册的业务所在地,则须就此器材将其责任委任给欧盟境内的单一授权代表。」。」-修正案42第二条,第七点 -第十四条,第2项,第1款


  • 授权代表(31个EEA加盟国)
  • 提供欧州内的注册地址
  • 技术文件内容检视
  • 技术文件保管与更新
  • 标示法规遵循与语言要求
  • 报告事故与处理客诉
  • 以非欧盟制造商名义处理第一类器材的上市前通告以及国家器材注册
  • 临床试验通告


| Home | Contact Us | Get a Quote |


in 來自Obelis的CE標示服務

MDlaw.eu is an Information Platform on the EU Medical Devices Regulation (MDR), which aims at meeting information needs on the future regulatory framework on medical devices in Europe.

The objective of the MDlaw platform is to help the medical device community prepare for an easy & successful transition to the new MDR requirements.

MDlaw platform aims to provide:

  • European Commission’s Implementing Acts and other Notices
  • Medical Device Coordination Group (MDCG) documents
  • Judgments & Rulings of the European Court of Justice
  • National competent authorities documents
  • Publications by CAMD, NBOG
  • Regulatory updates
  • Position Papers
  • MDR Analysis
  • And more…

Additional Special Features:

  • 108 Questions & Answers on MDR – touching upon the most relevant topics of the Medical Devices Regulation.
  • From MDD to MDR: Transition Management Tool – presenting seven techniques for a smooth transition of economic operators to the new EU regulatory framework.

Find all Medical Device Regulation related documents in 1 place (!) – at MDlaw.eu!


Subscribe NOW and get 3 Months FREE (!)

Visit www.mdlaw.eu to complete your subscription


in 來自Obelis的CE標示服務

法国器材注册服务 (en)

希腊器材注册服务 (en)

意大利器材注册服务 (en)

拉脱维亚器材注册服务 (en)

葡萄牙器材注册服务 (en)


| Home | Contact Us | Get a Quote |


in 來自Obelis的CE標示服務

根据欧洲医疗器材指令93/42/EEC以及体外诊断指令98/79/EC,只有通过CE标示,并于27个欧盟会员国以及4个EFTA成员国内正确注册的器材,才能自由进入欧盟市场(根据MDD 93/42/EEC的第十四条,经2007/47/EC修改,以及IVDD 98/79/EC的第十条)。因此,只要您的器材有正确通过CE标示,就能获得欧盟境内的流通以及销售许可。
•    该器材须有CE标示
•    制造商已为该器材指定欧盟授权代表

•    器材的信息
•    器材的名称与形式
•    分类(根据EU规章)
•    成分与描述
•    CE证书
•    关于制造商的信息
•    名称与连络信息
•    生产地
•    认证机构的连络信息

| Home | Contact Us | Get a Quote |

Clinical Data & Post Marketing Follow Up

in 來自Obelis的CE標示服務

Most medical device companies that currently sell CE-marked medical devices are getting nervous thinking about implementation of EU-MDR compliance and new certification. Especially related to the necessity to present sufficient clinical evidence to support the general safety and performance requirements.  The Medical Devices Regulation applicable as of 26 May 2020 will significantly raise the bar for clinical data.

Among  the new requirements:

  • A clinical evaluation plan and  a clinical evaluation report  is required for all device including class I.
  • The clinical evaluation shall follow a defined and methodological sound procedure and be based on MEDDEV 2.7.1/rev.4 and Annex XIV of the MDR
  • Especially related to the necessity to present sufficient clinical evidence to support the general safety and performance requirements
  • The clinical data should be sufficient to demonstrate compliance with the safety and performance requirements .
  • The clinical evaluation should include a  critical evaluation of the results of all available clinical investigations whether positive or negative
  • The method of appraising the literature need to be documented to assure your critical evaluation, without any bias or underexposure of unfavorable data.
  • Consideration of currently available alternative treatment options for that purpose
  • State of the art against which to measure safety and performance  must be established from Literature Review
  • In order to rely on clinical evidence of  an similar  device already marketed, the biological, technical and clinical equivalence will need to be demonstrated scientifically. Furthermore manufacturer will need to  have sufficient access to design data of the t device with which he claims equivalence.

Results of clinical investigations and/or Post Marketing Clinical Follow Up Studies that you performed in the past or that are currently ongoing, will be very valuable for your clinical evaluation. Similarly results from your post market surveillance process including some form of active collection of data will also represent  an  important input into your clinical evaluation which will be part of your Technical File to be assessed by your Notified Body.

It is therefore urgent for all medical devices manufacturers to critically and objectively analyze the foundation of their Clinical Evaluation Report and assess whether they have clinically sufficient evidence for future MDR compliance? Some devices will surely lack sufficient clinical evidence and might indispensably require some form of active data collection (PMS/PMCF).

As EU Consultant, Obelis can help you understand the new requirements, perform a gap analysis, and assist you to develop a solid plan for clinical data compliance.


in 來自Obelis的CE標示服務

•    适应权利与法规建议
•    质量管理提醒(QMS)的实施
•    产品安全性咨询
•    产品测试与许可服务
•    确认适用的法令
•    确认欧盟协调标准
•    上市后监督的协助
•    法规咨询与更新

| Home | Contact Us | Get a Quote |


in 來自Obelis的CE標示服務

•    器材分类。
•    相关标准的验证。
•    风险管理报告以及差距分析。
•    临床证据报告以及差距分析。
•    安全性以及生物相容性。
•    供货商/分包商合约的指导。
•    模板与检查表。
•    标示与包装。

| Home | Contact Us | Get a Quote |


in 來自Obelis的CE標示服務


  • 器材分类。
  • 符合性评鉴选择的验证。
  • 认证机构的提案的分析。
  • 认证机构的交涉。



| Home | Contact Us | Get a Quote |


in 來自Obelis的CE標示服務


  • 在职培训
  • 欧盟协调标准
  • 自由销售证明服务
  • CE注册证书
  • GMDN代码搜索
  • 标示翻译
  • 通关代码验证
  • 欧盟商标申请
  • 欧盟环保规章
  • 协议咨询与检查服务
  • MDD重要要求之CD


| Home | Contact Us | Get a Quote |


in 來自Obelis的CE標示服務


  • 进出国际网络的能力
  • 规范解决方案
  • 国际代表


| Home | Contact Us | Get a Quote |