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Notified Bodies intention to submit designation application MDR and/or IVDR

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By Davide Turchi – RA/QA Consultant

 

Introduction

Without any doubts, Notified Bodies are a particular type of entity that is highly affected by the new Medical Devices and In-Vitro Diagnostics Regulations. Notified Bodies will be strictly assessed and audited by the European Commission and National Competent Authorities in order to receive accreditation to certify medical devices under the New Regulations.

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Registrate to

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Take the quizz to find out if you are ready to enter the EU Market with your product(s).


New Directive Regarding Teeth Whitening Products

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The European Commission has recently issued a new Directive (Council Directive 2011/84/EU) regarding tooth whitening products, under which these are classified as cosmetics products. These were formerly classified as medical devices under the Medical Device Directive (MDD 93/42/EEC). The new Directive also makes reference to restrictions and conditions of use of hydrogen peroxide in teeth bleaching products.

According to the new Directive, only dental bleaching products with less than 0.1% hydrogen peroxide may be sold on the open market in the European Union. Furthermore, products having between 0.1%-6% hydrogen peroxide content may only be sold to dentists, while all other tooth whitening products with more than 6% hydrogen peroxide are forbidden in the European Union, as an additional measure on product safety for the European consumers.

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CD of Essential Requirements for MDD

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As you may know the 2007/47/EC amended the MDD 93/42/EEC which may have an immediate impact on the compliance of your medical devices in Europe.

There are two main amendments that are particularly important.

  1. A decreasing of the importance of the Medical Device Directive 93/42/EEC in respect to all other European Directives.
  2. The influence of the Machinery Safety Directive on the MDD 93/42/EEC (medical devices with moving parts), which will result in the combination of essential requirements in regards to both Directives.

• Both of which will be in full force by March 21st, 2010.

Obelis has created a CD presenting the following valuable guidelines:

  • A table of essential requirements for MDD and MSD, written by Dr. Peter N. Ruys, one of the initial officials to implement the Medical Device Directive in Europe.
  • A consolidated version of the Directives MDD 93/42/EEC with the amendments from Directive 2007/47/EC
  • A Consolidated table of Essential Requirements of the MDD 93/42/EEC & the 2007/47/EC – NEW!
  • The MSD 2006/42/EC
  • A list of the European Standards under EU Machinery regulation

We are confident this CD will assist you in your understanding of the implementation of these new amendments.

You can order this CD by emailing us at marketing3@obelis.net .

As an Obelis client you may purchase the CD at a discounted rate of €150.00(euro).

Do not hesitate to contact us with any questions or concerns.


Post Market Surveillance

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The European Commission obliges all manufacturers to have in place a Post Market Surveillance System as referred to in General Product Safety Directive (crossing Personal Protective Equipment, Low Voltage Devices, Toys, Devices emitting Electromagnetic waves, and Cosmetics) Article 5, the Medical Device Directive Annexes II-VII, and In-Vitro Device Directive Annexes III, IV, VI and VII.

In regards to P.M.S., the European Commission defines it as a way “to improve the protection of health and safety of patients, users and others by reducing the likelihood of the same type of adverse incident being repeated in different places at different times” MEDDEV 2.12-1 rev 4 April 2001.

Conducted either proactively or retroactively PMS can take the form of:

  • Focus Groups
  • Customer surveys
  • Customer complaints and warranty claims
  • Post CE-market clinical trials
  • Literature reviews
  • User feedback
  • Device tracking/implant registries
  • User reactions during training programs
  • The media
  • Experience with similar devices made by the same or a different manufacturer
  • Maintenance/service reports
  • Retrieval studies on explants or trade-ins
  • In-house testing
  • Failure analysis

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Environmental Directives Services

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GiDoS Green Regulatory Center is a quality driven, service oriented company dedicated to assisting European and non-European manufacturer’s successful compliance with Environmental Directives and Regulations within Europe.

Based upon in-depth research and years of regulatory experience, GiDoS experts will work with you to orchestrate a complete Environmental Regulatory Strategy; thus implementing solutions for full compliance during the entire duration the product/device resides on the European market. Additionally, GiDoS offers tailored compliance services for the WEEE, RoHS and P&PW, as well as Only Representative services under REACH 1907/2006.

European “Green” Directives and Regulations are becoming prevalent and crucial points of interest for anyone involved in placing products on the European market. A comprehensive Environmental Strategy is necessary to study and satisfy the requirements you are constrained to abide by.

Our Services for WEEE 2002/96/EC, RoHS 2002/95/EC, and P&PW 94/62/EC:

GiDoS examines country’s regulations and European directives to identify the environmental requirements for your product(s) per product, per country.

  • Upon request, GiDoS can keep you updated on member-state requirements of all EU countries you export to and notify you of any regulatory changes that might affect your product(s).
  • GiDoS identifies the necessary marking and labeling requirements for your product(s) according to the European environmental directives.
  • GiDoS investigates the recovery and treatment requirements of individual European member-states for WEEE and present you with different options for the recovery of your product(s).
  • GiDoS compares the substances in your product(s) with the hazardous substances limited by the RoHS directive and identify which substances you need to replace or eliminate.
  • GiDoS provides instruction on what to include in your records on the mass of WEEE components, materials, and substances according to WEEE 2002/96/EC Art. 10, 11.
  • GiDoS explains how to complete the process of producer registration required by the directives.
  • GiDoS provides guidance on guaranteeing the recycling, energy, composting, and biodegradation requirements of the P&PW directive.

Trade Mark Services

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“CTMR 88 (1), (2) The Community Trade Mark Regulation obliges natural and legal persons not having their domicile or their principal place of business or a real and effective industrial or commercial establishment in the Community to be represented, in all proceedings before the Office other than the filing of a CTM application, by a professional representative, namely either a legal practitioner or a person whose name is entered on the list of professional representatives maintained by the Office”.

Through its extended network of collaborators, OEARC can now provide you with cost effective and simplified trade mark and design registration for the entire EU.


Services for GMDN Code Verification

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Obelis – Licensed Consultant for GMDN Codes

The GMDN (Global Medical Device Nomenclature) Agency, is an international non-profit organisation which has been appointed by its stakeholders, Medical Device Regulators and Industry, to manage the GMDN database and maintain the nomenclature.

The Global Medical Device Nomenclature (GMDN) provides the use of generic descriptors for the identification of medical devices and other Healthcare related products, mostly under the scope and definition of the MDD 93/42/EEC.
More and more, the GMDN is considered as the leading nomenclature and is being requested by the various industry players and authorities, such as at the time of MDD Class I Pre-Market Notifications or National Device Registration (such as in Italy or Portugal).

A GMDN code can only be a 5 digit code – The database contains over 20,000 defined terms for medical devices.

There are 3 types of term that the database contains:

  • Preferred Terms (P terms) – used for identifying devices for regulatory purposes.
  • Template Terms (T terms) – collections of terms, used for finding P terms.
  • Synonym Terms (S terms) – historic or common names of devices, used for finding P terms.

Obelis is a licensed consultant for the GMDN agency.
If you are not familiar with your GMDN codes, Obelis can assist you finding the correct GMDN code for your device.


Services for On-Site Training

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Obelis is pleased to announce a new service offering dedicated training sessions by our regulatory team on site at our clients’ premises. Such on-site training can be dedicated to the general framework and requirements of the Directive as well as specific training aimed at our clients’ specific situation or requests.

  • Obelis Senior Regulatory Expert, Dr. Peter Ruys – MDD, AIMDD & IVD On-Site Training
  • Obelis Regulatory Expert, John L. Webster – MDD, AIMDD & IVD On-Site Training
  • Obelis C.C.O. Ms. Sandra Ferretti – Cosmetic On-Site Training

The on-site training usually consists of a 2 day workshop, held in our clients’ office with the appropriate set-up, such as a meeting room with screen and projector. Each participant will receive copies of slides and other relevant material as well as a certificate of attendance. The training will be performed in English and the maximum quantity of participants is 12. The price depends on the number of participants, subjects treated and the travelling required between Obelis head office and the client’s office.


Medical device registration process in Italy

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Documentation needed:

In order to proceed with the device registration Obelis will need from you the following information in an electronic format:

  • 1 manufacturer’s representative designation document signed (template to be provided)
  • 1 list of the Medical device (those which are / will be sold in Italy)
  • 1 technical file for each product (.pdf or .doc) 
  • 1 copy of valid CE certificate 
  • 1 copy of valid ISO certificate 
  • 1 GMDN codes of the products to be registered *.

Registration number will be provided at the end of the process.

* The device registration in Italy has to be made also per GMDN code. If you are not familiar with GMDN, the Global Medical Device Nomenclature (GMDN) provides the use of generic descriptors for the identification of medical devices and other Healthcare related products.
If you do NOT know the GMDN codes for your products, Obelis can find them out for you, this is a separate service we provide to our clients. We would need from you a very accurate product description (usage, composition).

Process & Time frame (6-8 weeks) dependent on:

  1. All the documents have been provided to Obelis’ Notification department.
  2. The number of products in question (time might be longer in case of a large quantity of products).
  3. The Italian Competent Authority promptitude.
  4. The Italian Database functionality.