Medical device regulation (Germany)

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Basic data
Title: Medical Device Regulation
Short title: Medical device regulation
Abbreviation: MPV
Type: Federal Ordinance
Scope: Federal Republic of Germany
Issued on the basis of: Section 37 subs. 1, 8, 11 MPG
Legal matter: Administrative law , trade law
References : 7102-47-6
Original version from: December 17, 1997
( BGBl. I p. 3138 ,
ber.p. 515 )
Entry into force on: December 24, 1997
Last revision from: December 20, 2001
( BGBl. I p. 3854 )
Entry into force of the
new version on: 		January 1, 2002
Last change by: Art. 3 Regulation of September 27, 2016
( Federal Law Gazette I p. 2203, 2208 )
Effective date of the
last change: 		January 1, 2017
(Art. 5 of September 27, 2016)
Please note the note on the applicable legal version.

The Medical Devices Ordinance (MPV) regulates the evaluation and determination of the compliance of medical devices with the basic requirements according to § 7 of the Medical Devices Act (MPG) ( conformity assessment ), the special procedures for systems and treatment units and the change in the classification of medical devices in Germany.

The European Medical Device Regulation of the same name must be distinguished from the German MPV .

Content of the regulation

  • Section 1 Scope and General Requirements for Conformity Assessment
  • Section 2 Requirements for the conformity assessment procedures
    • § 4 Conformity assessment procedure for active implantable medical devices
    • § 5 Conformity assessment procedure for in-vitro diagnostics
    • § 6 Conformity assessment procedure for medical devices manufactured using animal tissue
    • § 7 conformity assessment procedure for the other medical devices
  • Section 3 Changes to the Classification of Medical Devices
  • Section 4 Transitional Provisions
    • § 10 Transitional provision for medical devices made using animal tissue
    • § 11 Transitional provisions for joint replacement for hip, knee and shoulder

Web links