In-Vitro Diagnostic Medical Device Directive
- Non-EU must appoint an Authorized Representative which is established within the community
- General IVDs may self-certify without the intervention of a Notified Body in order to affix the CE Marking
- All Others will require a QMS & Technical File to be audited by a European Notified Body
- All IVD products must undergo a pre-Market Notification before being made available
- General requirements that must be met by manufacturers (Essential Requirements) are outlined in Annex I of the IVD Directive
- There is no grandfathering-in for products which have already been selling on the EU Market - manufacturers must remain up-to-date with the most recent requirements
- IVD products are not "approved" for sale in the EU - Competent Authorities focus on in-market controls to verify compliance
Table of Contents
- The Directive: IVDD 98/79/EEC
- Path to EU Market Entry
- Pre-Market Notification
- Notified Body
- Authorized Representative
- Risks of Non-Compliance
- New Regulation Proposal: 541/2012 Compliance
The directive applies to In-Vitro Diagnostic Medical Devices and their accessories. Whereas it is assumed that accessories shall be treated as In-Vitro Diagnostic Medical Devices in their own right.
Certain devices are excluded from the scope of the directive. According to Article 1 of the directive, a decision whether a device is within the scope of the directive will depend upon the intended purpose of the device and the claims for it.
“For research use only” devices are not usually considered to be IVD medical devices. This means that the device must have no medical intended purpose, no medical objective and it should not have a performance evaluation function.
The Directive: IVDD 98/79/EC
IVD 98/79/EC (In-Vitro Diagnostic Medical Device Directive) was published on October 7, 1998. It is separate from the Medical Device Directive with its own separate set of requirements for manufacturers wishing to place medical devices in the European Economic Area. This directive does not specifically list out the devices that fall under it. Rather, the responsibility is placed on the manufacturer to determine what directives apply to their device. The directive sets out device requirements, requirements for manufactures placing the device on the market, and also demands on safety and quality of the devices.
“any medical device which is a reagent, reagent device, calibrator, control material, kit, instrument, apparatus, equipment or system whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state of health or disease or congenital abnormality or to determine the safety and compatibility with potential recipients”.
Path to EU Market Entry: Compliance
Each In-Vitro Device manufacturer must develop their own compliance program which addresses their particular device categories and business needs. The following are general steps to compliance:
- Determination of the applicable standards (European, International or National)
- Assessment and classification of your device (depending on the specific function of an In-Vitro Diagnostic Medical Device and whether or not it is listed in Annex II)
- Identification of the appropriate conformity assessment module according to your device classification
- Preparation of a “Technical File” including a user manual (Annex III, section 3)
- Implementation of “Quality Assurance System” (Annex III, section 4)
- Selection of a Notified Body within the European Economic Area to perform the official conformity assessment tasks
- Preparation of an “EC Declaration of Conformity”
- Affixing of the CE Marking in accordance with the directive
For non-EU manufacturers: Appoint a European Authorized Representative established within the European Community
The European Standards that are presumed by the European Commission to provide technical definition for demonstrating conformance to the “essential requirements” in the directive are published in the “Official Journal of the European Community”. While other national, regional or international standards can be used as well, European Standards are preferred since they are presumed by the European Commission to address the “essential requirements” contained in the directive.
Manufacturers should test your device, determine its conformance to the appropriate legal requirements and construct a corresponding Technical File that should be available in the European Economic Area. Manufacturers also need to affix the required “CE Marking” Logo to the device before placement in the market. In many cases, manufacturers can self-certify that their devices meet the legal requirements contained in the directive. In most instances, such a self-certification requires the use of European Standards.
The “Declaration of Conformity” must be prepared and must contain the following information:
- The manufacturer’s name and full address, telephone, fax numbers and e-mail
- The European Directive complied with
- Device identification
- Standards used to verify compliance with the directives
- Name of “Notifying Body” and its identification number
- The “Authorized Representative’s” name and full address, telephone, fax numbers and e-mail
The “Declaration of Conformity” and the “Technical Files” need only be written in “English”. However, instruction manuals need to be in the local language of the end user.
The European Competent Authorities are the local regulating bodies in each member state responsible for fulfilling the obligations of market control. All IVDs require notification to the Competent Authorities and a European Authorized Representative for each device placed on the market. The Notified Body will issue the appropriate certification after an exhaustive assessment to ensure that all relevant requirements have been met. Subsequently, manufacturers can place the CE marking on their devices demonstrating their compliance with the requirements.
Notification pressure for IVDs:
Any manufacturer who places a device on the European market has to notify the competent authorities of each Member State concerned by that placing on the market.
For non-EU manufacturers: Appoint a European Authorized Representative established within the European Community.
Notified Bodies for In-Vitro Diagnostic Medical Devices
Notified Bodies are tasked with ensuring that all the in-vitro diagnostic medical devices placed on the EU Market are safe and compliant. They assist the manufacturers to carry out conformity assessment procedures and grant conformity certificates to in-vitro diagnostic medical devices.
There are certain criteria that a Notified Body must meet before the EU Authorities can designate them. Their role mainly consists of inspecting the technical documentations of Self-Testing IVD medical devices and IVDs listed on the Directive’s Annex II (list A and list B). Selecting a Notified Body for an in-vitro diagnostic medical device is an important process. Manufacturers can consult the European Commission´s complete directory of Notified Bodies (available on the NANDO website).
Selecting the right Notified Body for your EU Compliance requirements can be a daunting task. Contact us for help in your Notified Body Selection needs!
An Authorized Representative is any person naturally or legally established in the European Community who is explicitly designated by the manufacturer to act on their behalf. This person may be addressed by authorities and bodies within the Community, instead of the manufacturer themselves, with regards to the requirements of this Directive.
What are the duties of an E.A.R?
The role of a European Authorized Representative is both varied and challenging. The main duties include, but are not limited to, the following:
- Providing a registered address within the European Union
- Keeping all technical documentation available for inspection by the European Authorities
- Completing notifications to European Authorities
- Completing any registrations to national databases
- Taking care of any incident reporting
- Representing the manufacturer towards the European Commission, Authorities and Notified Bodies
- Safeguarding and ensuring compliance with constant regulatory updates
- Consulting on European Regulations
Non-EU based manufacturers are obligated to appoint a European Authorized Representative to serve as their vigilance contact point and ensure continued compliance at all times.
Risks of Non-Compliance
The directive portrays European Law enforced within the EEA; non-compliance with the directive’s requirements will result in the removal of the device from the market and the revoking of the CE marking affixed on the device.
- Product recall
(a) where a Member State establishes that the CE marking has been wrongly affixed, the manufacturer or his authorised representative shall be obliged to end the infringement under conditions imposed by the Member State;
(b) where non-compliance continues, the Member State must take all appropriate measures to restrict or prohibit the placing on the market of the product in question or to ensure that it is withdrawn from the market, in accordance with the procedure in Article 8.
2. The provisions stated in paragraph 1 shall also apply where the CE marking has been affixed in accordance with the procedures in this Directive, but inappropriately, on products that are not covered by this Directive.
New Regulation Proposal: 541/2012 Compliance
A Proposal for a new Regulation on In-Vitro Diagnostic Medical Devices has been adopted by the European Commission on 26 September 2012 in the context of a broader revision of the regulatory framework for Medical Devices.
The proposal is currently undergoing the Ordinary Legislative Procedure. It has been adopted by the European Parliament on 2 April 2013 and shall now be discussed by the Council.
The main novelties proposed consist in:
- Clearer and broader scope for the IVD legislation, in particular with regard to:
- High-risk devices manufactured and used within a single health institution, which are subject to most of the requirements set out in the proposal;
- Tests providing information about the predisposition to a medical condition or a disease (e.g. genetic tests) and tests providing information to predict treatment response or reactions (e.g. companion diagnostics), which are considered as in vitro diagnostic medical devices;
- Medical software, which is explicitly mentioned in the definition of IVDs.
- Clear definition and explicit identification of the respective tasks of the different Economic Operators (namely the manufacturer, the authorized representative, the importer and the distributor).
- Stricter obligations for the manufacturer, which are proportionate to the risk class of the devices they produce. This implies – for example that:
- All manufacturers should have a quality management system (QMS) in place to ensure that their products consistently meet the regulatory requirements;
- QMS-related responsibilities are stricter for manufacturers of high-risk devices than for manufacturers of low-risk devices;
- The Manufacturers is the sole responsible for the drawing up of the key-documents for the aimed at demonstrating the compliance with the legal requirements of each device placed on the market. These are the technical documentation and the EU declaration of conformity.
- Specific provisions concerning product’s traceability consisting of:
- A requirement that manufacturers fit their devices with a Unique Device Identification (UDI) which allows traceability;
- A requirement that manufacturers/authorized representatives and importers shall register themselves and the devices they place on the EU market in a central European database;
- An obligation for manufacturers of high-risk devices to make publicly available a summary of safety and performance with key elements of the supporting clinical data;
- Further development of the European databank on medical devices (Eudamed),
- Clear identification of the general requirements for clinical evidence for in vitro diagnostic medical devices which are proportionate to the risk class.
- For the purpose of the Regulation ‘clinical evidence’ means the information that supports the scientific validity and performance for the use of a device as intended by the manufacturer
- Manufacturer will always need to demonstrate the products’ conformity with the general safety and performance and the intended purpose of the device on the basis of clinical evidence.
Moreover the proposed Regulation shall introduce some new concepts the field of IVDs:
- Requirement for the manufacturers to have a qualified person within their organization. The ‘qualified person’ should be responsible for regulatory compliance;
- Identification of clear conditions for the relabeling and/or repackaging IVDs.
Under the proposed Regulation the general obligations of the manufacturer shall consist in:
- Ensure the product compliance with the relevant essential requirements;
- Draw up the Technical Documentation, the Declaration of Conformity and the other documents aimed at demonstrating the product’s compliance with the EU legislation
- Carry out the necessary conformity assessment procedures (that may vary in proportion with the level of risk of the concerned device).
Manufacturer established outside the European Union MUST appoint an European Authorized Representative.
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