Medical Devices Act

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Medical Products Act (MPG for short) refers to the national implementation of the European directives 90/385 / EEC for active implantable medical devices, 93/42 / EEC for medical products and 98/79 / EC for in vitro diagnostics in Germany and Austria .

With the Medical Devices Act, the Medical Device Ordinance (MedGV) that had been in force until then, which only applied to medical-technical devices, was replaced. Before the Medical Devices Act came into force, the legal regulations for medical devices were scattered across a large number of laws. There was neither a uniform term “medical product”, nor was the law relating to medical products standardized (codified). Medical Products under fell partly the medical device Regulation (MedGV), the Food and Consumer Goods Act or the pharmaceutical legislation . These different regulations with their different requirements as well as the lack of a uniform definition of the term medical product made uniform application of the law difficult and did not do justice to the innovative market with medical products. With the entry into force of the Medical Devices Act, these weaknesses could be eliminated and the law relating to medical devices codified. Now the term medical product is clearly defined in § 3 MPG and in § 2 the scope of the Medical Devices Act including the delimitation from other products (e.g. drugs , cosmetic products and transplants ) and legal matters are clearly defined.

The medicinal products are to be separated from the medical devices and thus withdrawn from the scope of the Medical Devices Act. The main difference between medical devices and drugs lies in their intended main effect. While drugs have a pharmacological, immunological or metabolic effect, medical devices are assigned a physical mode of action. The manufacturer (definition in Section 3 No. 15 MPG) is responsible for determining this so-called purpose. The intended purpose, which is thus determined subjectively, results from the labeling of the product, the instructions for use or the advertising material (Section 3 No. 10 MPG). While the intended effect of drugs is predominantly determined objectively, i. H. According to scientific knowledge, a subjective determination applies to medical devices, although here too the manufacturer is not fundamentally free and can arbitrarily assign his product to the Medical Devices Act. In the past, a large number of higher regional courts had to deal with the distinction between medical devices and medicinal products or cosmetic products, primarily in the context of actions for injunctive relief under competition law. This makes it clear that determining the intended effect is not always easy because the assessment is often based on scientific knowledge.

EU-wide requirement

The European directives 90/385 / EEC, 93/42 / EEC and 98/79 / EC (as "master directives") and 2003/32 / EC, 2005/50 / EC and 2007/47 / EC (as "amending directives") contain the legal requirements for the initial placing on the market (initial supply from the manufacturer to the retailer or end user) and the initial commissioning of medical devices (provision for use or application) in the European Economic Area (EEA), which are implemented by the national legislation of each EEA signatory state Need to become.

With the European medical device law, an observation and reporting system was set up that works together with the other contracting states of the European Economic Area; it serves to record and avert risks from medical devices . Medical devices that are marketable in a member state of the European Union under European law are also marketable in the other member states.

This means that the entire EU market for medical devices is available to manufacturers, distributors, patients and doctors . All medical devices are covered by medical device law. The medical devices that are marketable according to European and thus also according to national medical device law have the CE mark ("CE" originally stood for "Communautée Européenne", i.e. "European Community") (which is also prescribed for toys, electrical appliances and other product types) to recognize. A 4-digit identification number after the CE logo identifies the so-called notified body in Europe that has checked compliance with the requirements of 93/42 / EEC ( EC conformity assessment ).

European medical device law is based on the principle: less government in favor of the manufacturer's responsibility (or the first importer into the EU community). It also serves to privatize state tasks. The conformity assessment procedure is carried out by the manufacturer himself. For products of Class I, sterile and / or with measuring function, IIa, IIb and III, certification by private or state (e.g. in Spain) test centers is also required. These are named by state or federal bodies (e.g. in Germany, by the Central Office of the Länder for Health Protection for Drugs and Medical Devices , ZLG). The tasks of the supervisory authorities are to monitor those responsible, the products, the test centers, the risks that have occurred and the clinical trials. Monitoring is carried out by inspecting the production facilities and products, checking the manufacturer's technical documentation including clinical data, and evaluating incident reports. The ZLG is responsible for the designation and monitoring of the test centers ( notified bodies ).

On September 26, 2012, the European Commission presented the proposal for a new EU Medical Device Regulation . The aim of the proposal was to combine the previous directives on active and other medical devices into a set of rules that will apply directly in the EU member states, i.e. also in Germany and Austria, from 2017 at the earliest without national implementation. At the same time, but separately, the European IVD directive is to be converted into an EU IVD regulation .

Since February 22, 2017, finalized versions of both EU regulations have been available for a “Council position” in the Council's first reading on March 7, 2017. Both ordinances will come into force after a second reading in the EU Parliament (in April 2017), then 20 days after their announcement in the EU Official Journal (June / July 2017).

As a result of the PIP scandal in 2011, the EU regulation proposals were accompanied by a catalog of immediate measures ( Dalli Immediate Action Plan) by the EU Commission, during which the EU Commission issued two legal acts:

  • Implementing Regulation (EU) No. 920/2013 of the Commission of September 24, 2013 on the designation and supervision of notified bodies according to Council Directive 90/385 / EEC on active implantable medical devices and Council Directive 93/42 / EEC on medical devices
  • Commission recommendation of September 24, 2013 on audits and assessments carried out by notified bodies in the field of medical devices (2013/473 / EU)

Germany

Basic data
Title: Medical Devices Act
Short title: Medical Devices Act
Abbreviation: MPG
Type: Federal law
Scope: Federal Republic of Germany
Legal matter: Commercial administrative law
References : 7102-47
Original version from: August 2, 1994
( Federal Law Gazette I, p. 1963 )
Entry into force on: January 1, 1995
New announcement from: August 7, 2002
( BGBl. I p. 3146 )
Last change by: Art. 223 VO of June 19, 2020
( Federal Law Gazette I p. 1328, 1354 )
Effective date of the
last change: 		June 27, 2020
(Art. 361 of June 19, 2020)
Weblink: Text of the law
Please note the note on the applicable legal version.

The Medical Devices Act (MPG) contains the technical , medical and information - requirements for the marketing of medical devices (through manufacture or import) in the European Economic Area (EEA). The MPG is established on 1 January 2002 Medical Device Regulation finally be replaced (MedGV 1985), with the division, untouched remained MedGV in groups of medical devices, which were produced until 1994 in accordance with and these medical devices is not new according to Medical Device Directive (MPBetreibV) into classes were divided. This means that the rules and regulations of the MedGV are retained for these medical devices (manufactured until 1994).

Via the Medical Devices Operator Ordinance (MPBetreibV), operator and user regulations for medical devices also apply .

The Medical Devices Act will be replaced on May 26, 2021 by the Medical Device Law Implementation Act for all products within the scope of Regulation (EU) 2017/745 (Art. 15 of the Act of May 19, 2020, Federal Law Gazette I p. 1018, 1034 ). For in-vitro diagnostics, it is still to be used temporarily until May 25, 2022 (Section 2 (1) of the Medical Device Implementation Act).

Responsibility and Control

The following authorities are responsible for carrying out the tasks according to Section 32 (1) to (3) MPG:

In addition, the German Institute for Medical Documentation and Information (DIMDI), as a federal agency with no legal capacity and within the division of the Federal Ministry of Health (BMG) , carries out the statutory tasks according to § 33 MPG in connection with the DIMDI regulation.

Ordinances and penal provisions

With six criminal provisions, the Medical Devices Act also contains ancillary criminal law .

According to § 4 MPG, it is forbidden to put medical devices on the market, to install, to put into operation, to operate or to use if there is a reasonable suspicion that they could affect the safety and health of patients, users or third parties if they are properly Application, maintenance and their intended use are dangerous beyond what is justifiable according to the knowledge of medical science or their expiry date has expired.

It is further elaborated by ordinances:

The “announcements” and “notifications” of the Federal Ministry of Health (BMG) explain some of these legal ordinances (MPBetreibV, DIMDIV, MPSV and MPKPV).

Medical Device Dispensing Ordinance (MPAV)

On July 29, 2014, the ordinance on the dispensing of medical devices and amending medical device regulations came into force ( BGBl. 2014 I p. 1227 ).

The core of the article regulation is the repeal of the previous regulations on the prescription requirement and the pharmacy requirement for medical devices. They will be replaced by a "medical product dispensing ordinance" which regulates the dispensing of certain medical products for lay use. For all other medical devices that are used under medical supervision, the previous prescription and pharmacy obligation does not apply.

The

  • MPBetreibV: Operator regulation, which u. a. requires the introduction of an implant passport,
  • MPKPV: Ordinance on clinical trials - Ordinance simplifying the approval procedure for clinical trials at the BfArM,
  • MPSV: Safety Plan Ordinance - with the deregulation that serious adverse events are only to be reported when the product is purchased; In a parallel hearing, the question will be discussed whether the failure to report adverse events ("incidents") by the medical staff (users and operators) to the BfArM is also sanctioned, i. H. should be fined,
  • DIMDI regulation with new internal information requirements and the recording of SAE reports.

Austria

Basic data
Title: Medical Devices Act
Long title: Federal law on medical devices (Medical Devices Act MPG)
Abbreviation: MPG
Type: Federal law
Scope: Republic of Austria
Legal matter: Administrative law
Reference: BGBl. No. 657/1996
Date of law: November 29, 1996
Effective date: January 1, 1997
Last change: Federal Law Gazette I No. 59/2018
Legal text: Text of the Medical Devices Act
Please note the note on the applicable legal version !

The Austrian Medical Devices Act came into force on January 1, 1997, the Austrian Medical Device Operator Ordinance on April 1, 2007. Both were implemented by the Federal Law on Medical Devices published on December 30, 2009 (Medical Devices Act, MPG) in accordance with the EU Directive 2007/47 / EG amended EU directives 90/385 / EEC and 93/42 / EEC modified.

literature

  • Rainer Hill, Joachim M. Schmitt: WiKo - medical product law. Loose-leaf commentary, Verlag Dr. Otto Schmidt, 21st edition. Status: October 2019, ISBN 978-3-504-04002-4 , with online case law database : www.wiko-mpg.de
  • Erwin Deutsch, Hans-Dieter Lippert, R. Ratzel, B. Tag: Commentary on the Medical Devices Act (MPG) , 2nd edition. Springer-Verlag, Heidelberg 2010, ISBN 978-3-540-89450-6 .
  • Armin Gärtner: Medical device legislation and regulations. (Medical Device Safety, Volume 1). TÜV Media Verlag, 2008, ISBN 978-3-8249-1146-2 .
  • Rehmann, Wagner: MPG. Comment. 2nd Edition. Verlag CH Beck, Munich 2010, ISBN 978-3-406-60151-4 .
  • Gert Schorn (Ed.): Medical product law. Comment. (Loose-leaf collection in several volumes), 25th delivery. Scientific publishing company, Stuttgart August 2009, ISBN 978-3-8047-2614-7 .
  • Uwe Kage: The Medical Devices Act, State Risk Control Under the Influence of European Harmonization, Springer-Verlag Berlin Heidelberg New York 2005, ISBN 3-540-21932-3
  • Uwe Kage: Nöthlichs (Ed.), Safety Regulations for Medical Devices , loose-leaf comment, Erich Schmidt Verlag GmbH & Co. KG, Berlin 2014, 36th Supplementary delivery as of May 2015, ISBN 978-3-503-03681-3

Web links

Individual evidence

  1. ↑ Statutory ordinances on the Medical Devices Act (subject area FNA 7102-47)
  2. ↑ Ref .: 121-40102-09