001-Device Certificate

  1. THAILAND
  2. EUROPE

Medical Device



Medical device directive 93/42/EEC

Categories of Medical Device

European Committee is categorizing medical devices into three different categories

  • Medical Device, 93/42/EEC (MDD)
  • In Vitro Diagnostic Medical Device, 98/79/EC (IVD)
  • Active Implantable Medical Devices, 90/385/EEC (AIMDD)

 

The Basis

The very basis. Your medical shall be CE marked to ensure free movement in the European market.

 

Classification

Each directive classifies the devices as

  • MDD: Class I, Im, Is, IIa, IIb and III
  • IVD: List A, List B, and General
  • AIMDD: No specific mention but treated as Class III MDD


How do I CE Mark my device?

Affixing CE mark on your device mean you have fulfilled all applicable essential requirements of the directive. That means the manufacturer has proven safety and effective of the device through Clinical Evaluation.

 

How do I Clinically Evaluate my device?

Generate and/or establish quantitatively and qualitatively sufficient clinical data pertinent to the device in question. There are several different sets of data recommended to be included in your clinical evaluation.

  • device description including design features,
  • information needed for evaluation of equivalence,
  • risk management documents,
  • state of the art knowledge of the device (applicable standards and guideline),
  • pre-market clinical investigation,
  • data retrieved from literature; and
  • pre-clinical studies (tests, verification, and validation data)

Clinical evaluation revision 4

Previously, the European Commission has issued and recommended to follow a guideline for clinical evaluation called MEDDEV. 2.7.1. Rev.3. The document was issued on Dec. 2009.

Now the guideline has been revised to revision 4. The new guideline was issued in June 2016.

Overall procedures and contents of the new clinical evaluation guideline are like the previous one. However, requirements and examples are now described in detail. This means, if you are familiar with previous clinical evaluation, you will not have much trouble adapting into revision 4. However, you are likely to spend much more time to prepare the contents of the clinical evaluation. Because so many things are clarified.

One of the most import requirement which is specified in revision 4 is the requirements for demonstration of equivalence.

Most of manufacturers are not able and/or willing to generate clinical data by their own. Because generating clinical data means conducting clinical investigation, which is costly and time consuming. While manufacturers with class III, or newly developed medical devices do not seem to have much choice, other manufacturers, who manufacture medical device which have been distributed and used in the market for long enough that generating any new clinical data will not be necessary, they have other routes to complete their clinical evaluation.

One of the most common way to complete the clinical evaluation was by demonstrating equivalence with a device which is already CE marked and has been distributed in the E.U. market for long enough time, and enough quantity.

Now, the guideline revision 4 requires you to demonstrate equivalence in clinical, technical, and biological perspectives. Basically, you will need data of raw materials of the device you have chosen to demonstrate equivalence with.

 

Medical Device Regulation

When to adapt it?

The Medical Device Directive is now switching into Regulation. The real big deal. The legislative procedure is in the very final stage and expected to come into effective very much anytime soon. (as of Jan 2017)

Of course, the notified bodies are required to apply for a new designation and will have to go through a thorough verification and evaluation during transitional period. Only after then, they will be starting to accept new application for device certification under new regulation. This means the manufacturers might still have few more years of transitional period. Obviously, some of the notified bodies will complete their designation and start applying MDR sooner than others. Our recommendation is, if you have experience of having trouble exporting your products to E.U. member states because of some problem of your certificate that you were not fully aware of, find one that adapts the MDR fast and be settled.

What has been changed?

First, definitions are added, changed, amended, and specified more in detail. Now application of the regulation shall be determined based on risk level of, which are so-called “border line device.” MDR even has a “LIST OF PRODUCTS COVERED BY THE LAST SUBPARAGRPAH OF THE DEFINITION OF ‘MEDICAL DEVICE’ REFERRED TO IN NUMBER (1) OF ARTICLE 2(1), Annex XV” Which are

  • Contact lenses.
  • Implants for modification or fixation of body parts.
  • Facial or other dermal or mucous membrane fillers.
  • Equipment for liposuction.
  • Invasive laser equipment intended to be used on the human body.
  • Intense pulsed light equipment.

Devices listed on Annex XV were previously more of “Cosmetic equipment’s” and notified bodies would not accept the application because of the device do not alien with definition of medical device in previous directive.

Some other important amendments are

  • classification rules
  • addition and amendment on essential requirements
  • additional requirements for PMS,
  • assessment of medical device service provided via internet,
  • new manufacturer’s responsibilities,
  • gap assessment against of QMS and its criteria,
  • gap assessment against new recall requirements,
  • mandatory insurance for product liability,
  • new requirements to authorized representative,
  • review of autonomous general obligation of importers and distributors,
  • appointment of responsible person for regulatory compliance,
  • new requirements for relabeling and/or repackaging
  • use of UDI on label,
  • additional requirements on traceability,
  • essential requirements