The Eudamed

The European Commission announced (Commission Decision, April 19, 2010) that Eudamed, the databank for medical devices, will become mandatory for all Competent Authorities in the European Union as of May 1, 2011. Until then, use of the databank is voluntary. It is important to note here, however, that the databank will not be accessible publically. Instead, access to Eudamed will be reserved for Competent Authorities and likely Notified Bodies and other national regulatory agencies.

The creation of Eudamed was in response to the growing need for a collective and shared post-market surveillance system. To this end, Eudamed will serve as a database that will collect details on incidents and, according to the European Commission, will "give an overview to every member state of the incident history of a device present on the market." Related to this goal, Eudamed will include information on incidents or near-incidents of a particular medical device.

According to the European Commission, the following information will be captured by Eudamed:

Registration of manufacturers, authorized representatives and devices;
Data relating to certificates issued, modified, supplemented, suspended, withdrawn or refused;
Data obtained in accordance with the vigilance procedure;
and Data on clinical investigations.

Conformity Assessment by Notified Body

Identify whether an independent conformity assessment is required from a Notified Body. Conformity assessment is required for all devices except Class I (non-sterile, non-measuring). Each directive covering your product specifies whether an authorised third party (Notified Body) must be involved in the conformity assessment procedure necessary for CE marking.

Once the manufacturer has received certification from the notified body they may CE mark the products and place them on the market.

Clinical Evaluation, Clinical Investigation

Clinical evaluation is the assessment and analysis of clinical data pertaining to a medical device in order to verify the clinical safety and performance of the device. Clinical evaluation is an ongoing process conducted throughout the life cycle of a medical device. It is first performed during the conformity assessment process leading to the marketing of a medical device and then repeated periodically as new clinical safety and performance information about the device is obtained during its use. Sterling Medical Registration provides with clinical evaluation and studies services with accordance to EU MDD regulations.

Quality Management System - ISO 13485 : 2016

To ensure that devices manufactured in series production continue to be in conformity with the requirements of this Regulation and that experience from the use of the devices they manufacture is taken into account for the production process, all manufacturers should have a quality management system and a post-market surveillance system in place which should be proportionate to the risk class and the type of the device in question.

Product Testing and Conformity

Testing the product and checking its conformity to the EU legislation (Conformity Assessment Procedure) is the responsibility of the manufacturer. Risk assessment procedure has to be carry out. (ISO 14971).

Standards

Compliance with a harmonised standard will give a presumption of conformity with the Regulations. Identify the directive(s) and harmonised standards applicable to the product Classification.

Classification

Determine your medical device classification with accordance to the EU regulations. Classification is based risk device : Class I (non-sterile, non-measuring)  - generally regarded as low risk Class I (sterile, measuring) - generally regarded as low risk Class IIa - generally regarded as medium risk Class IIb - generally regarded as medium risk Class III/AIMD - regarded as high risk.

General Safety and Performance Requirements - GSPR

Devices shall achieve the performance intended by their manufacturer and shall be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose. They shall be safe and effective and shall not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety, taking into account the generally acknowledged state of the art.

In order to ensure these requirements are met, the Medical Device Regulation (EU) 2017/745 require manufacturers to include in their technical documentation a Checklist of General Safety and Performance Requirements to demonstrate compliance by indicating the Standards, common specifications, scientific advice and applicable reference. Click here to download the Checklist

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Affixation of the CE MARK

The CE conformity marking shall consist of the initials ‘CE’ taking the following form:

It should be at least 5mm in size, and should appear on the packaging and on the device itself where this is practicable. Instruction leaflets should also carry the CE mark. If the marking is reduced or enlarged the proportions given in the above graduated drawing must be respected.
The various components of the CE marking must have substantially the same vertical dimension, which may not be less than 5 mm. This minimum dimension may be waived for small-scale devices.

Technical Documentation

The manufacturer has to establish the technical documentation required by the directive(s) for the assessment of the product’s conformity to the relevant requirements, and for the risk assessment. For Class III/AIMD devices, prepare a Design Dossier, for all other devices, prepare a EU Technical File. Together with the EU DoC, the technical documentation must be presented on request to the relevant national authorities.

The UDI - Unique Device Identification System for Medical Devices

The Unique Device Identification (UDI) is a unique number pertaining to a medical device that enables the identification of different types of devices, and the access to useful and relevant information stored in a UDI database. Due to the UDI's specificity, it can make traceability of devices more efficient, allow easier recall of devices, fight against counterfeiting, and improve patient safety. By its definition, the UDI - unique device identification’ means a series of numeric or alphanumeric characters that is created through an internationally accepted device identification and coding standard and allows the unambiguous identification of specific medical devices on the market. The UDI comprises the device identifier and production identifier. The UDI system covers medical devices, as well as active implantable medical devices and in vitro diagnostic (IVD) devices On September 27, 2007, the Food and Drug Administration Amendments Act of 2007 was signed into law. The Act sets out measures for implementing the UDI system, which will require devices to carry a unique identifier and the UDI to allow identification through both use and distribution. The UDI will not be a substitution, but an addition, to the existing labelling requirements for medical devices. The European Commission leads an Ah Hoc Working Group at the Global Harmonisation Task Force (GHTF) level in order to draft recommendations and guidelines to ensure that the US UDI will be globally compatible. The idea is to promote a global approach in order to avoid discrepancies between the different UDIs produced by the different GHTF/AWHP (Asia Working Harmonisation Party) members.

A globally harmonized and consistent approach to UDI is expected to increase patient safety and help optimize patient care by facilitating the:

1.     traceability of medical devices, especially for field safety corrective actions,
2.    adequate identification of medical devices through distribution and use,
3.     identification of medical devices in adverse events,
4.    reduction of medical errors,
5.    documenting and longitudinal capture of data on medical devices.

The European Commission has published recommendations dated of 5 April 2013 on a common framework for a unique device identification system of medical devices in the Union (2013/172/EU).

European Authorized Representative Appointment - EU REP

Where a manufacturer who places a device on the market under his own name does not have a registered place of business in EU, he shall designate An Authorized Representative. Appoint an Authorized Representative (EU REP) located in Europe. The Authorized Representative has to be qualified to handle regulatory issues. The EU REP name and address should be placed on the Instructions for Use and, packaging. Appoint your Authorized Representative with us.

GSPR

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Europe CE Marking Approval Process

CE Marking

CE marking is a key indicator of a product’s compliance with EU legislation and enables the free movement of products within the European market. By affixing the CE marking on a product, a manufacturer is declaring, on his sole responsibility, conformity with all of the legal requirements to achieve CE marking and therefore ensuring validity for that product to be sold throughout the EEA, the 27 member states of the EU and European Free Trade Association countries - Iceland, Norway, Liechtenstein and Turkey. This also applies to products made in third countries which are sold in the EEA and Turkey.

CE marking is a legally binding statement by the manufacturer that their product has met all of the requirements of the Medical Devices Directive (MDD 93/42/EEC), In Vitro Diagnostic Device Directive (IVDD 98/79/EC) or the Active Implantable Medical Device Directive (AIMDD 90/385/EEC).

Before CE marking can be affixed to the product, the manufacturer must follow certain procedures which may differ for each directive and each product. Thus, you must place a CE Mark (CE Marking) on your product before you can sell a medical device or IVD within Europe.

The new Medical Device Regulations - MDR 2017/745

On 5 April 2017, 2 new Regulations on medical devices were adopted, and they entered into force on 25 May 2017. These replace the existing Directives.

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU.

The new rules will only apply after a transitional period. Namely, 3 years after entry into force for the Regulation on medical devices (spring 2020) and 5 years after entry into force (spring 2022) for the Regulation on in vitro diagnostic medical devices.

The Commission welcomes the adoption of its proposal for 2 Regulations on medical devices which establish a modernised and more robust EU legislative framework to ensure better protection of public health and patient safety.

The new Regulations contain a series of extremely important improvements to modernise the current system:

stricter ex-ante control for high-risk devices via a new pre-market scrutiny mechanism with the involvement of a pool of experts at EU level
the reinforcement of the criteria for designation and processes for oversight of Notified Bodies
the inclusion of certain aesthetic devices which present the same characteristics and risk profile as analogous medical devices under the scope of these Regulations
the introduction of a new risk classification system for in vitro diagnostic medical devices in line with international guidance
improved transparency through the establishment of a comprehensive EU database on medical devices and of a device traceability system based on Unique Device Identification
the introduction of an “implant card” containing information about implanted medical devices for a patient
the reinforcement of the rules on clinical evidence, including an EU-wide coordinated procedure for authorisation of multi-centre clinical investigations
the strengthening of post-market surveillance requirements for manufacturers
improved coordination mechanisms between EU countries in the fields of vigilance and market surveillance

Commission Implementing Regulations

Commission Implementing Regulation (EU) 2017/2185 of 23 November 2017 on the codes for the designation of notified bodies in medical devices under Regulation (EU) 2017/745 and in vitro diagnostic medical devices under Regulation (EU) 2017/746.

How to place a CE marking on a product ?

Conformity Assessment Process

A conformity assessment process has to be carry out by manufacturers in order to demonstrate that their medical devices meet the essential requirements of the Medical Devices Directive (MDD).