Medical Devices Directive

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The Directive: MDD 93/42/EECScope Classification Technical FileComplianceNotified Bodies for Medical DevicesCustom MadeClinical InvestigationKitsNew Regulation Proposal: 542/2012 Compliance |

The Directive: MDD 93/42/EEC

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MDD 93/42/EEC (Medical Device Directive) has been in place since June 14, 1998. It was amended on September 5, 2007. The consolidated directive became mandatory on March 21, 2010. The directive establishes essential requirements and harmonized standards for the manufacture, design, and packaging of medical devices. A medical device is defined as any instrument, apparatus, appliance, software, material or other article. This includes if this device is used alone or in combination with software necessary for its proper application intended by the manufacturer to be used for human beings in the purpose of:

  • diagnosis, prevention, monitoring, treatment or alleviation of disease
  • diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap
  • investigation, replacement or modification of the anatomy or of a physiological process control of conception and which does achieve its principal intended action by pharmacological process, immunological or metabolic means but may be assisted in its function by such means.

The Medical Device Directive calls for all manufacturers who distribute in the European Economic Area to comply with essential requirements that benefit the safety of those in the EEA. The devices must be designed and manufactured in such a way that as they are used by patients, they will in no way compromise the health of the patient. Other areas included and outlined in the directive are requirements regarding design and construction, materials used in the production of the device, and reduction of risk as far as possible to the patient. The directive ensures that the performance of the device promised by the manufacturer is achieved. The Medical Device Directive is necessary due to the differences of safety, health protection, and performance characteristics among Member States and thus causes barriers to trade within the Community. The harmonized standards of the Medical Device Directive allow for free movement within the market.

The MDD 93/42/EEC has been amended in 2007. The 2007/47/EC amendment was established on September 5, 2007 and the consolidated directive became mandatory on March 21, 2010. The amendment is necessary due to continual advancements in technology and development of international initiatives. The Commission is to constantly analyze the directives in order to ensure the protection of the patients. The amendment has such changes as the definition of a medical device, things which are not considered a medical device, explanation of Member State’s role, etc.


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Scope

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Devices which fall under the directive include:

Any device, apparatus, appliance or material used on human beings for the purpose of diagnosing, treating, preventing, monitoring, or alleviating a person’s condition as well as in conjunction with those who are injured or handicap. A medical device can also be defined in this directive as any of the previously listed in concurrence with conception. If any of these relate to your device, it is classified as a medical device.


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Classification

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Classes

The Medical Device Directive establishes in Annex IX the different classifications for devices.

    • Class I-Devices low risk such as stethoscopes, bandages, etc. The devices are non-evasive. The manufacturer must complete a technical file.
    • Class I sterile-Devices are low risk such as stethoscopes, bandages, etc. The devices are non-evasive. The manufacturer must complete a technical file and apply to a European Notified Body to get certified in the area of manufacturing dealing with sterility.
    • Class I measuring-Devices are low risk such as stethoscopes, bandages, etc. The devices are non-evasive. The manufacturer must complete a technical file and apply to a European Notified Body to get certified in the area of manufacturing dealing with metrology.
    • Class IIa-Devices low-medium risk devices such as a hearing-aid. Devices that are within the body between 60 minutes and 30 days fall within this class. This class also warrants technical files as well as having a European Notified Body perform a conformity test.
    • Class IIb-Devices are medium-high risk. The devices in this class are in the body more than 30 days. Examples include ventilators and intensive care monitoring equipment. Compliance route is the same as Class IIa with an additional step of type examination of the device by the European Notified Body.
    • Class III These are high-risk devices. Some examples are balloon catheters and prosthetic heart valves. The steps to approval are audit of the full quality assurance system and examination of the design by the European Notified Body examination and testing of the device.

18 Rules of Classification

      • Rule 1Devices that either do not touch the patient or contact intact skin only.
      • Rule 2 – Channeling or storing for eventual administration.
      • Rule 3 – Devices that modify biological or chemical composition of blood, body liquids or other liquids.
      • Rule 4 – Devices in contact with injured skin.
      • Rule 5 – Devices invasive in body orifices.
      • Rule 6 – Surgically invasive devices for transient use except if there are reusable surgical instruments.
      • Rule 7 – Surgically invasive devices for short term use.
      • Rule 8 – Surgically invasive devices for long term use and implantable devices.
      • Rule 9 – Active therapeutic devices intended to exchange or administer energy.
      • Rule 10 –Active devices for diagnosis.
      • Rule 11 – Active devices to administer, remove medicines and other substances to or from the body.
      • Rule 12 – All other active devices.
      • Rule 13 – Devices incorporating a medicinal substance.
      • Rule 14 – Devices used for contraception or prevention of sexually transmitted diseases.
      • Rule 15 – Specific disinfecting, cleaning and rinsing devices.
      • Rule 16 – Non-active devices to record X-ray diagnostic images.
      • Rule 17 – Devices utilizing animal tissues or derivatives.
      • Rule 18 – Blood bags.

For non-EU manufacturers: Appoint a European Authorized Representative established within the European Community.


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Technical File

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A Technical File is proof that a medical device complies with the essential safety and health requirements set down by the relevant Directive(s). Technical Files are required for all classes of medical devices – Class I, Is, Im, IIa, IIb, III – and they must hold essential information about the medical device, including photographs and diagrams. A Technical File can be compiled in any of the official languages of the EU. However, English is the most commonly used. An up to date electronic or hard copy of the file needs to be kept available in Europe allowing it to be presented to any EU Competent Authorities upon request. Manufacturers based outside the EEA are to make it available at the address of their European Authorized Representative. As part of the CE Marking process, it is also advised that an external expert reviews the Technical File. For more information about Technical Files, please see our Technical File Compliance page.


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Compliance

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Class I Non-Sterile
Img_MDD_Class I Non Sterile

Class I Sterile
Img_MDD_Class I Sterile

Class I Measuring
Img_MDD_Class I measuring

Class IIa
Img_MDD_Class IIa

Class IIb
Img_MDD_Class IIb

Class III
Img_MDD_Class III


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Notified Bodies for Medical Devices

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Notified Bodies play a key role in supporting manufacturers to place only safe and compliant medical devices on the EU Market. They help the manufacturers by carrying out conformity assessment procedures and grant conformity certificates to medical devices. There are certain expectations that a Notified Body must meet before being designated by the EU Authorities. A key aspect of their role is to inspect the technical documentations of MDD Is/Im, IIa and IIb as well as review and approve Design Dossiers (for Class III devices) towards granting CE Certificates or EC Design Dossier Certificates. Manufacturers can consult the European Commission´s complete directory of Notified Bodies (available on the NANDO website). However, as selecting a Notified Body device can be a complex process, it is also advised that an external expert supports this critical decision. For more information about Notified Body for medical devices, please see our Notified Body Selection page.


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Custom Made

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The Medical Devices Directive and the Active Implantable Medical Devices Directive define the “custom-made device” as any device which is specifically made in accordance with a duly qualified medical practitioner’s written prescription which gives, under his responsibility, specific design characteristics. A custom-made device is intended for the sole use of a particular patient. (MDD 93/42/ EEC Article 1 (2) (c); AIMDD 90/385/EEC Article 1 (2) (d)).

  • Examples of qualified medical practitioners: Dentist, Ophthalmologist, Orthotist, Ocularist.
  • Example of custom-made devices: Orthopaedic footwear, Maxillofacial Prosthesis.

Special note: mass-produced devices which need to be adapted to meet the requirements of a healthcare professional, even though they are supplied for the sole use of a particular patient, are not considered as custom-made. (e.g., contact lenses).

Steps to place a custom-made device on the EU market

Step 1:

Compliance with all the essential safety & health requirements that apply to the device (see compliance with the MDD 93/42/EEC or compliance with the AIMDD 90/385/EEC);

Step 2:

Non-EU Manufacturer appointing an Authorized Representative in Europe;

Step 3:

Draw up a statement concerning the custom-made device (MDD 93/42/EEC Annex VIII Point 2.1; AIMDD 90/385/EEC Annex 6 Point 2.1);

Step 4:

Notification the Competent Authority of the intention of placing a Custom Made device onto the European Market ( MDD 93/42/EEC Article 11 (6));

Custom-made devices do not bear the CE marking. (MDD 93/42/EEC Article 17 (1); AIMDD 90/385/EEC Article 12 (1)) ;

Custom-made devices do not require the intervention of a Notified Body.

Non-Compliance

The directive portrays European Law enforced within the European Economic Area (EEA); non-compliance with the directive’s requirements will result in the removal of the device from the EEA. (MDD 93/42/EEC Annex VIII (5));


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Clinical Investigation

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MDD 93/42/EEC (Medical Device Directive), amended by the 2007/47/EC, requires clinical data and an evaluation of that data to ensure the safety of the medical device. Clinical data is collected or generated from the clinical use of the device and observing the performance of this device and its safety. The following activities allow for obtaining this data:

    • Published data on clinical experience with the device or equivalent
    • Clinical investigation
    • Clinical investigation with similar device
    • Combination of the above

The medical devices must go through clinical evaluation which is the process of assessing clinical data and making sure that the data is in conformity with the harmonized standards and essential requirements that have been established by the European Union. This clinical evaluation proves that the device is safe and performs according to its intended purpose established by the manufacturer.

The clinical evaluation must follow a certain procedure based on either.

  1. The relevant scientific literature currently available evaluating the design characteristics, safety, and performance of the device all based on its intended use where:
      1. there is demonstration of equivalence of the device to the device to which the data relates and
      2. the data adequately demonstrates compliance with the relevant essential requirements
  2. A critical evaluation of results of all clinical investigations made
  3. Critical evaluation of data of the combined clinical data provided by literature and clinical investigation.

When a clinical evaluation is not appropriate, there must be adequate justification based on risk management output and under consideration of the specifics of the device/body interaction, the performances intended and claims of the manufacturer. Clinical evaluation also is focused on those elements of safety and/ or performance that could not be based on laboratory testing. Medical Device Directive Annex VIII requires that all clinical testing has been performed properly.

Manufacturer’s responsibility

Clinical investigation is the systematic study or investigation of safety and performance of a device being used by human beings in accordance with the device’s normal use.

Manufacturer is responsible for the:

    • Design of the study
    • Designation of principal investigator
    • Application with ethical committee
    • The non-EU manufacturer may choose to appoint an Authorized Representative to complete the notification of the clinical investigation to the relevant EU Member State competent authority
    • Incident Reporting-in the event of an incident during the clinical investigation, the reporting as such will need to be determined and performed by the appointed Authorized Representative
    • Documentation available-the clinical investigation data (reports) should be incorporated in the technical documentation that has to be kept available by the manufacturer of his appointed European Authorized Representative established within the Community

Clinical Investigation plan

    • Clear measurable objectives
    • Criteria to stop the trial
    • Statistical power
    • Patient population equivalent to EU

The clinical evaluation and its documentation must continually be updated by its post-market surveillance information. If this post-market surveillance is not needed for some reason in following up on the medical device, an acceptable justification must be given and documented. For high risk devices, there must be a clinical follow-up report given with the final report.

Role of the Competent Authority

Approval to begin process of investigation

    • Some countries require 60 days
    • Other countries allowed to begin right upon submission of request

There must also be a registration in the European Databank.

Role of the European Notified Body

Investigation must be reviewed by the Notified Body who has such authority.

    • Assessment of clinical safety and performance
    • Conclusion with justification

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Kits

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The Medical Devices Directive refers to two specific manners of placing medical devices together under a single packaging onto the European Market:

“Systems” or “Procedure Packs” (MDD 93/42/EEC Article 12);

A “procedure pack” can be defined as an assembly of medical devices that are packed together and sold on the market with the intention of being used during procedures (e.g., surgical procedure) or medical treatment.

The devices in the “procedure pack” are not required to be used in combination or at the same time. Moreover, the manufacturer of the procedure pack may be the manufacturer of all the devices from the procedure pack, or may put in the procedure pack devices having different manufacturers.

Example of procedure packs:

    • First aid kits;
    • Packs for specific surgical procedure;
    • Orthodontic procedure packs.

A “system” can be defined as an assembly of medical devices that are designed to be used solely in combination one with the other, and cannot achieve the claimed medical intended purpose alone (see scope of a medical device).

Example of systems:

    • Prosthetic system;
    • Joint replacement system.

Please note that a “system” or “procedure pack” (KITs) comprising medical devices, all devices must undergo individual conformity assessment procedures and bear the CE marking individually while the KIT itself will not be CE marked;

Steps to place a KITS on the EU market

Step 1.

Compliance with all the essential safety & health requirements that apply to the device (see compliancewith the MDD 93/42/EEC);

    • Comply with the essential requirements (MDD 93/42/EEC Annex I);
    • Technical documentation (MDD 93/42/EEC Annex VIII Point 3.1) ;
    • Vigilance system;

Step 2.

Non-EU Manufacturer appointing an Authorized Representative in Europe;

Step 3.

Notification the Competent Authority of the intention of placing a Medical Kit (“System” or “Procedure Pack” onto the European Market ( MDD 93/42/EEC Article 12));


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New Regulation Proposal: 542/2012 Compliance

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On April 2nd, 2014 the European Parliament adopted a resolution introducing 347 amendments to the European Commission’s proposal for a new Regulation on medical devices. This resolution introduces the amendments that were initially voted on 22 October 2013 on first reading of the Commission’s proposal.

In accordance with the co-decision procedure, the text is now under review of the Council for 1st reading. At this stage, 2 outcomes are possible:

    • The Council may side with the Parliament’s position, in which case the legislative act will be adopted;
    • The Council may amend the text adopted by the Parliament’s, and return the proposal to Parliament for a 2nd reading.

When the new text will be adopted, medical manufacturing companies will have to make sure they are in compliance with new CE marking requirements in order to lawfully affix the CE mark.

The key amendments introduced by the European Parliament to the Commission’s proposal for a new Regulation on medical devices are:

    1. Introductions of rules concerning the reprocessing of single use devices: all medical devices are to be considered reusable and suitable for reprocessing by default. Only devices that will be defined by the Commission as being ‘unsuitable for reprocessing’ may be single use.
    2. Involvement of the Special Notified Bodies in the conformity assessment procedures of high-risk devices (e.g. class III and implantable devices) that would be designated by the European Medicines Agency (EMA).
    3. Introduction of medical devices for aesthetic purposes within the scope of the proposal for a Regulation on medical devices.
    4. The Unique Device Identification system proposed by the Commission was endorsed by the Parliament.
  •  Introduction of a prior approval by competent authorities in order to prove conformity with general safety and performance requirements by other means than clinical data. The possibility to use non-clinical testing methods to prove conformity is restricted to low-risk devices.

 

It is still unsure whether the Council will support the above-mentioned points. Obelis, in its role of European Authorized Representative, is constantly watching legislative developments so as to make sure to provide medical manufacturing companies with the best advisory services on CE marking.


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