Technical File Review

Technical documentation can be referred to as a number of names—technical file, EU documentation, EU dossier, Product Information File, Product Information Packet and more.

In order your products to legally enter the EU Market and continue to circulate, you must have valid documentation which demonstrates that they are safe for the end-user and are reflective of the essential safety and health requirements as laid out in the relevant legislation.

Each manufacturer is responsible for creating their own technical documentation and in most—if not all cases—must provide a declaration of conformity thereby declaring compliance with the law. Finding the time or expertise to create a fully compliant EU technical file among other competing projects and priorities can be a challenge for many small to medium-sized manufacturers.-

Technical File

A Technical file (also referred to as Technical Documentation or TF) is a document proving that a medical device is compliant with the essential safety and health requirements set down by the relevant Directive or Regulation. It is required for all classes of medical devices – Class I, Is, Irsi, Im, IIa, IIb, III as well as all in vitro diagnostic medical devices – and must be created by manufacturers before having the CE Marking affixed on their product(s).

The technical documentation for a compliant MDR or IVDR device must follow Annex II and III of the MDR or IVDR, as applicable, 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; Nevertheless, the national authority might request a part of the file to be translated. however, English is the most commonly used, since it allows the document to be easily understandable by anyone who has to revise it (e.g. EU and National Authorities, Notified Bodies, and Authorized Representatives).

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.

The manufacturer is expected to periodically review and update the Technical File, and all changes must be recorded.

As part of the CE Marking process, it is also advised that an external expert reviews the Technical File.

If you have an existing technical file and some familiarity with the EU essential safety & health requirements, our technical file review services may fit the bill. Alternatively, if you’re entering the EU for the first time or don’t know where to start with, getting our help with a technical file creation as part of our consultancy services may be what you are looking for.

Technical Documentation

A Technical Documentation is proof that a medical device complies with the essential safety and health requirements set down by  the relevant Directive(s) and Regulations. Technical Documentations are required  for all classes of medical devices – Class I, Is, Ir, Im, IIa, IIb, III – and they must hold essential information about the medical device,  and may include photographs and diagrams. The Member State in which the Notified Body is established may require the technical documentation to be made available in an official language determined by that Member State. In absence of such requirement, the technical documentation shall be provided in a language acceptable by the notified body.

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 EU 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 Documentation.  For more information about Technical Documentations, please see our Technical Documentation Compliance page.

Clinical Evaluation Reports will now be required of Class I manufacturers where they were not previously.

If you existing technical file has not yet undergone a critical gap analysis in order to make the necessary upgrades under the Medical Device Regulation, it is advisable to do so as soon as possible.

Clinical Data Post-Marketing Follow-Up

Most medical device manufacturers that currently sell CE-marked medical devices are getting nervous thinking about implementation of the EU-MDR compliance and new certification. Especially related to the necessity to present sufficient clinical evidence to support the general safety and performance requirements.  The Medical Devices Regulation applicable as of 26 May 2021 will significantly raise the bar for clinical data.

  • A clinical evaluation plan and  a clinical evaluation report  is required for all device including class I.
  • The clinical evaluation shall follow a defined and methodological sound procedure and be based on MEDDEV 2.7.1/rev.4 and Annex XIV of the MDR
  • Especially related to the necessity to present sufficient clinical evidence to support the general safety and performance requirements
  • The clinical data should be sufficient to demonstrate compliance with the safety and performance requirements.
  • The clinical evaluation should include a critical evaluation of the results of all available clinical investigations whether positive or negative
  • The method of appraising the literature need to be documented to assure your critical evaluation, without any bias or underexposure of unfavorable data.
  • Consideration of currently available alternative treatment options for that purpose
  • State of the art against which to measure safety and performance must be established from Literature Review
  • In order to rely on clinical evidence of a similar device already marketed, the biological, technical and clinical equivalence will need to be demonstrated scientifically. Furthermore, manufacturer will need to have sufficient access to design data of the t device with which he claims equivalence.

Results of clinical investigations and/or Post Marketing Clinical Follow Up Studies that you performed in the past or that are currently ongoing, will be very valuable for your clinical evaluation. Similarly, results from your post market surveillance process including some form of active collection of data will also represent  an  important input into your clinical evaluation which will be part of your Technical Documentation to be assessed by your Notified Body.

It is therefore urgent for all medical devices manufacturers to critically and objectively analyze the foundation of their Clinical Evaluation Report and assess whether they have clinically sufficient evidence for future MDR compliance! Some devices will surely lack sufficient clinical evidence and might indispensably require some form of active data collection (PMS/PMCF).

As EU Consultant, Obelis can help you understand the new requirements, perform a gap analysis, and assist you to develop a solid plan for clinical data compliance.

EU guidelines on the Product Information File

On November 25th 2013, the European Commission has published the Implementing Decision 2013/674/UE on Guidelines on Annex I to Regulation (EC) No 1223/2009, towards supporting the cosmetic industry to achieve compliance with the Regulation requirements.

The Guidelines list the data that should be available “as a minimum” with a cosmetic Product Information File – to be made readily available at the EU address of the Responsible Person.

  1. Quantitative & Qualitative composition of the cosmetic product
    Each raw material of the composition is to be identified and quantified
  1. Physical/chemical characteristics and stability of the cosmetic product
    Physical/chemical characteristics of substances or mixtures
    Physical/chemical characteristics of the finished product
    Stability of the cosmetic product under reasonably foreseeable storage conditions
    The methodology used to determine the product’s minimum durability
  1. Microbiological quality
    Microbiological quality of substances and mixtures
    Microbiological quality of the finished cosmetic product
  1. Impurities, traces, information about packaging material
    Purity of substances and mixtures. Impurities: unintended substances in raw materials
    Evidence of the technical unavoidability of traces of prohibited substances
    The relevant characteristics of the packaging material in direct contact with the product
  1. Normal and reasonably foreseeable use
    Section essential to determine a relevant exposure scenario
    Warning and other explanations on the labeling should be consistent with the identified normal and reasonably foreseeable use
  1. Exposure to the cosmetic product
    To quantify the amount of cosmetic product coming into contact with the external part of the human body or the teeth and the mucous membranes of the oral cavity
  1. Exposure to the substances
    To quantify the amount of each substance coming into contact with the external part of the human body or the teeth and the mucous membranes of the oral cavity
  1. Toxicological profile of the substances
    To describe the toxicological hazard of each of the substances in the finished product
    To determine the potential exposure
    To draw up a risk characterization
  1. Undesirable effects and serious undesirable effects
    Information on the cosmetic product
  1. Assessment conclusion
    A product can be assessed as: ‘safe’, ‘safe with restrictions’ or ‘not safe’
  1. Reasoning leading to the Assessment conclusion
    This must cover:
    Safety Evaluation of substances & mixtures
    Safety Evaluation of the Cosmetic product
  1. Warning & Precautions of use
    Must appear on the Cosmetic product label
  1. Assessor’s credentials
    Name and address, proof of qualification, date and signature

Future expectations
Manufacturers and Responsible Persons should cooperate together to achieve complete and compliant product information files taking into consideration that EU Member state Authorities will rely on the above guidelines when conducting post market surveillance activities.

Notified Body Services

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.

A European organization accredited/notified by an EU Member State Competent Authority with the aim to support the manufacturer with conformity assessment procedures & conformity certificates.

The Minimum Criteria to be met when designating Notified Bodies state that:

  • The NB shall not be the designer, manufacturer, supplier or installer of devices which they control, nor the authorized representative.
  • The NB shall possess the highest degree of professional integrity and technical competence and free of inducements.
  • The NB must have at its disposal the necessary staff and possess the necessary facilities & equipment.
  • The NB must have liability insurance.
  • The NB must practice professional secrecy.

Notified Bodies are designated by EU Authorities to assist the manufacturer and ensure they only bring safe and compliant products to the EU Market. Their duties include:

  1. Inspecting technical documentation.
  2. Carrying out conformity assessments.
  3. Issuing conformity certificates.
  4. Performing surveillance audits.

According to the Medical Device Directive, inspection by an accredited EU Notified Body will be required in the following instances:

  • MDDIs/Im, IIa and IIb and Self-Test IVD – the manufacturer must submit a full Technical File for review and approval by the Notified Body, and obtain a CE Certificate from the Notified Body before being able to place the CE marking on the device.
  • For all AIMD, Class III MDD and IVD Annex II List A & B devices, the manufacturer must submit a full Design Dossier for review and approval by the Notified Body, as well as obtain an EC-Design Examination Certificate from the Notified Body before being able to place the CE marking on the device.
  • There is no legal requirement for Notified Bodies to review technical documentation of MDD Class I(non-sterile and with no measuring function) and IVD ‘All Others’.

The European Commission provides a complete directory of Notified Bodies accredited for CE marking of medical devices. The Notified Body directory can be found on the NANDO website and lists over 60 Notified Bodies from 22 countries (including Turkey and Australia). Manufacturers can refer to a Notified Body of their choice.

Our Notified Body Selection services include:

  • Device Classification
  • Identification of conformity assessment options
  • Notified Body offer analysis
  • Notified Body negotiation

EU Trademark Submission

“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”.

The Global Medical Device Nomenclature (GMDN) 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 GMDN Agency 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).

What is a GMDN Code?

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.
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