MEDDEV documents are guidelines published by the EU Commission for medical device manufacturers and notified bodies in particular.

Caution: The MEDDEV documents are (largely) obsolete!

With the replacement of the EU directives MDD, AIMDD, and IVDD by the EU regulations MDR and IVDR, the MEDDEV documents are largely obsolete. One exception is, for example, the MEDDEV 2.7/1 rev 4 guideline.

Manufacturers and notified bodies should, therefore, always check whether there is a suitable MDCG guideline.

Please refer to the overview article on the MDCG guidelines and the MEDDEV documents linked there!

MEDDEV Dokumente

1. Contents of the MEDDEV documents

The MEDDEV documents cover several topics

a) 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

b) 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

c) Classification of medical devices

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

d) 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

e) 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 investigations
  • MEDDEV 2.7 / 3: Clinical investigations: recording of incidents
  • MEDDEV 2.7 / 4: Guidelines for clinical investigations: Information for manufacturers and notified bodies

f) Notified bodies

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

g) 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)

h) 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

A complete overview of the documents can be found on the EU website.

2. Who participates in the MEDDEV documents

The following are (officially) involved in the creation of MEDDEV documents:

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

3. 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. Undemocratic(?) and non-transparent process
    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. Lack of balance
    There are no representatives for patients’ interests in the board.
  3. Unclear legal obligation
    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. Outdated
    The MEDDEV documents are partly outdated. A revision was announced years ago without a visible and definitive result. In some cases, documents are referenced that are no longer valid. The same commission requires manufacturers to comply with the state of the art.
  5. Additional effort
    The MEDDEV documents increase the effort required for manufactures to incorporate medical devices into the regulatory landscape.
  6. Compensation for an inadequate legal system?
    The fact that the European legal system even needs the MEDDEV documents makes it clear that the directives are not sufficiently precise and complete.