MEDDEV stands for MEDical DEVices Documents. The MEDDEV Guidance Documents are developed by various working groups on behalf of the European Commission to assist stakeholders in implementing directives related to medical devices. The MEDDEVs promote a common approach to be followed by manufacturers and notified bodies that are involved in conformity assessment procedures. Although the guidelines are not legally binding, it is expected that the guidelines be followed, ensuring the uniform application of relevant directive provisions.
Who participates in the development of the MEDDEV documents?
The MEDDEV Guidelines were developed as part of a consultation process involving manufacturers’ associations, notified bodies, and standardization bodies. This way the intention was to implement the requirements of the legislation and in particular the annexes to the directives, but also the impulses of other bodies working to support public health, such as the GHTF / IMDRF.
Stakeholders involved in the MEDDEV Guidelines Development:
- The EU Commission
- Notified Bodies
- Industry representatives
- European Member States Authorities
- Standardization bodies and lobbyists
What does the MEDDEV Documents Cover?
Application of Guidelines
- MEDDEV 2.1/1: Definitions of the terms of medical devices, accessories and manufacturers
- MEDDEV 2.1/2 rev.2: Scope of the AIMD Directive
- MEDDEV 2.1/3 rev.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 rev.1: Electromagnetic compatibility
- MEDDEV 2.2/3 rev.3: Sequence / Sell by date
- MEDDEV 2.2/4: Conformity Assessment in In Vitro Fertilization
Classification of Medical Devices
- MEDDEV 2.4/1 rev.9: Classification of medical devices (in accordance with Appendix IX of the MDD)
Conformity assessment procedures
- MEDDEV 2.5/3 rev.2 : QM systems related to subcontractors
- MEDDEV 2.5/5 rev.3 : Translations
- MEDDEV 2.5/6 rev.1: Verification of “batches”
- MEDDEV 2.5/7 rev.1 : Conformity assessment concerning special products
- MEDDEV 2.5/9 rev.1: Evaluation of medical devices incorporating products containing natural rubber latex
- MEDDEV 2.5/10: Guideline for authorized representatives
Clinical evaluation and clinical examination
- MEDDEV 2.7/1 rev.4: Clinical evaluation: Information for manufacturers and notified bodies
- MEDDEV 2.7/2 rev. 2: Information for competent authorities in the evaluation of clinical trials
- MEDDEV 2.7/3 rev. 3: Clinical trials: recording of incidents
- MEDDEV 2.7/4: Guidelines for Clinical Trials: Information for manufacturers and notified bodies
Notified Bodies
- MEDDEV 2.10/2 rev.1: Appointment and monitoring of notified bodies (not by notified bodies) annex 1, annex 2, annex 3, annex 4
Market surveillance
- MEDDEV 2.12/1 rev.8 Guidelines on a medical devices vigilance system
- MEDDEV 2.12/1 rev.8: Additional guidance regarding vigilance systems
In Vitro diagnostics
- MEDDEV 2.14/1 rev.2: Classification of borderline products
- MEDDEV 2.14/2 rev.1: IVD solely for research purposes
- MEDDEV 2.14/3 rev.1: Manual/instructions for use (IFU for IVD
- MEDDEV 2.14/4: CE marking of blood based IVD
The MEDDEV documents are known to support manufacturers interpret the regulatory requirements described – in the directives in particular – but there is also criticism for these documents. The development is known to be opaque and drawn-out and has been criticized for not including any representatives for patients’ interests. Furthermore, the legal liability of the documents is unclear, with some Notified Bodies evaluating companies based on these MDEDDEV documents even if these documents go beyond the requirements of the directives.
Although the MEDDEV documents increase manufacturers’ regulatory effort, they require careful attention and adherence to reach regulatory compliance in the European Union.
Too many guidance documents? The AKRN Regulatory Affairs Team is happy to help you decipher which ones are required for your Technical File.