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ECM Notified Body 1282
Regulatory Approval Time is crucial. Whether you assign a dollar value to it or not, your time is valuable to ECM. The values and work ethic displayed by a company’s
CE Mark approval is the only way to gain access to the European market.
CE marking is the evidence that a medical device satisfies the ESR (essential safety requirements) of all relevant European Medical Device Directives and Regulations. The CE mark is a binding legal condition to distribute a medical device in the EU market.
ECM is a Notified Body under the Medical Device Directives (MDD), with consolidated technical expertise and experience to provide smooth, streamlined, fast CE marking services.
We understand that CE marking requirements can seem overwhelming. ECM trains and guides medical devices manufacturers along the CE marking approval process.
No matter your organization’s size, product types or location: our mission is to provide you with our dedicated attention and support to make your certification an easy one.
Detect and Satisfy ESR, Essential Safety Requirements
In accordance with EU regulations, the medical device is required to be reputed satisfactory in terms of certain vital sections:
Accuracyof intended use
- Possible risk vs. benefit
- Consequence due to transport/storage
- Labeling as well as other medical device specific items
Medical Device Status and Class
Based on their level of risk, medical devices must be categorized into classes: I, IIa, IIb, III. Other directives may also apply (e.g. devices containing human blood derivatives, animal tissues, pharmaceuticals or electrical elements).
Often identified as the Technical File, it contains the information to demonstrate Conformity and how the criteria indicated in the Harmonized Standards are met. It includes:
- Description of the devices, including accessories and variants
- Manufacturing Information
- Risk Management file
- Design Verification
- CER – Clinical Evaluation Reports
- QMS Manual based on ISO 13485 (link to ISO 13485), main procedures
- Test Reports (link to ECM Lab) (for example EMC, electrical safety,
physical chemical andmechanical properties)
- Labeling Draft declaration of conformity
- Device classification
- Declarations concerning medicinal substances, human or animal blood or tissues
- Instructions for use, labeling, operator and maintenance manuals
andother technical literature
- Constructional data, design calculations
- Device lifetime and stability studies
- Information regarding transport and storage of devices
- List of applicable harmonized standards
- PMS – Post Market Surveillance
- Packaging information for sterile products
- Sterilization process description and validation report
ECM is also an accredited ISO 17025 Testing Lab (link to ECM Lab) and NCB & CBTL (link to ECM NCB) for the CB Scheme Testing Certificates. As a separate service, manufacturers requesting product testing can take advantage of ECM Testing Labs facilities for
CE Conformity Assessment
CE marking can be a very time consuming and frustrating process. ECM offers alternative options (link to Time matters) for Technical Documentation Assessment, that can significantly reduce time and costs.
The Conformity Assessment itinerary includes some of the following aspects:
- Full Quality Assurance System
- Type/Design Examination
- EC Verification
- Quality Assurance System for Production
- Quality Assurance System for Product (excludes IVD and AIMD devices)
- Declaration of Conformity (“Self-Certification”)
DoC, Declaration of Conformity
The CE Declaration of Conformity (DoC) is much more than a piece of paper signed by the head of quality or regulatory affairs. It is a legal document that reflects a manufacturer’s commitment to quality and overall compliance with 93/42/EEC, the European Medical Device Directives (MDD).
The DoC is the subject of annexes V, VI, and VII. In each of them, the same basic concept applies, with the manufacturer stating compliance to each of the requirements in it.
Note on the EU Medical Device Regulation (MDR)
ECM has applied for the transition to MDR and extended the certification scope to 80% of the NBOG Codes including many Class III