MEDDEV – Medical Devices Documents

MEDDEV documents summarize the consensus of various working groups that would have been proposed later in the EU Commission. The contents are guidelines that will be developed for the application of the EU guidelines for medical products and are revised periodically. MEDDEV is derived from medical devices.

Contents of the MEDDEV Documents

The MEDDEV Documents cover several topics

Application of Guidelines 

  • MEDDEV 2.1 / 1: Definitions of the terms of medical devices, accessories and manufacturers 
  • MEDDEV 2.1 / 2: Scope of the AIMD Directive 
  • MEDDEV2.1 / 3: Borderline products for example products for administering medicines 
  • MEDDEV 2.1 / 4: Interfaces with other directives, e.g. with respect to electromagnetic compatibility (89/336 / EEC) and personal protective equipment (89/686 / EEC) 
  • MEDDEV 2.1 / 5: Medical devices with measuring functions 
  • MEDDEV 2.1 / 6: Classification of stand-alone software as a medical device

Basic Requirements 

  • MEDDEV 2.2 / 1: Electromagnetic compatibility 
  • MEDDEV 2.2 / 3: Sequence / Sell by date 
  • MEDDEV 2.2 / 4: Conformity Assessment in In Vitro Fertilization

Classification of Medical Devices 

  • MEDDEV 2.4 / 1: Classification of medical devices (in accordance with Appendix IX of the MDD)

Conformity assessment procedures

  • MEDDEV 2.5 / 3: QM systems related to subcontractors 
  • MEDDEV 2.5 / 5: Translations 
  • MEDDEV 2.5 / 6: Verification of "batches" 
  • MEDDEV 2.5 / 7 / and / 10: Conformity assessment concerning special products

Clinical evaluation and clinical examination

  • MEDDEV 2.7 / 1: Clinical evaluation: Information for manufacturers and notified bodies
  • MEDDEV 2.7 / 2: Information for competent authorities in the evaluation of clinical trials
  • MEDDEV 2.7 / 3: Clinical trials: recording of incidents
  • MEDDEV 2.7 / 4: Guidelines for Clinical Trials: Information for manufacturers and notified bodies

Notified Bodies 

  • MEDDEV 2.10: Appointment and monitoring of notified bodies (not by notified bodies)

Market surveillance

  • MEDDEV 2.12 / 1: Guidelines for a medical monitoring system 
  • There are further fillable PDFs and other forms, for example, for documenting incidents, corrective actions, reporting to customers 
  • MEDDEV 2.12 / 2: Clinical studies on market surveillance (post-market clinical follow-up)

In Vitro diagnostics

  • MEDDEV 2.14 / 1: Classification of borderline products 
  • MEDDEV 2.14 / 2: IVD solely for research purposes 
  • MEDDEV 2.14 / 3: Manual for IVD 
  • MEDDEV 2.14 / 4: CE labeling of blood-based IVD

Who participates in the MEDDEV documents

The MEDDEV documents work (officially) with

  • The EU Commission itself
  • Notified bodies
  • Industry representatives
  • Authorities for example
    1. for Germany, the Representatives ZLG, the Ministry of Health and its agencies in particular, the BfArM and the Paul Ehrlich Institute,
    2. for Switzerland, the Swissmedic
    3. and in Austria, the Federal Ministry of Health
  • Other stakeholders such as the standardization bodies and lobbyists

Review of the MEDDEV documents 

The MEDDEV documents support the manufacturer in that they specify the regulatory requirements - in particular the directives. However, there is also criticism for these documents:

  1. The process, in which the documents arise, is opaque and tedious so that the directly concerned medical device industry has difficulty participating in it.
  2. There are no representatives for patients' interests in the Board. 
  3. The legal liability is unclear: some notified bodies evaluate companies based on these MDEDDEV documents even if these documents go beyond the requirements of the directives or if only one of several interpretations of the EU directives are involved. 
  4. The MEDDEV documents are partly outdated. A revision was announced years ago without a visible and definitive result. 
  5. The MEDDEV documents increase the effort required for manufactures to incorporate medical devices into the regulatory landscape.
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