Directive 93/42 / EEC on medical devices
 Directive 93/42 / EEC |
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|---|---|
| Title: | Council Directive 93/42 / EEC of June 14, 1993 on medical devices |
| Designation: (not official) |
Medical Device Directive English: MDD (Medical Device Directive) |
| Scope: | EEA |
| Basis: | EEC Treaty , in particular Article 100a |
| Procedure overview: |
European Commission European Parliament IPEX Wiki |
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To be implemented in national law by: |
July 1, 1994 |
| Implemented by: | Medical Devices Act (Germany) |
| Reference: | OJ L 169 of 7/12/1993, pp. 1-43 |
| Full text |
Consolidated version (not official) basic version |
| The regulation must have been implemented in national law. | |
| Please note the information on the current version of legal acts of the European Union ! | |
Council Directive 93/42 / EEC of June 14, 1993 on medical devices is one of a total of three EU medical device directives and is referred to as the medical device directive in Germany and Austria for short . Internationally, the directive is referred to as the Medical Device Directive (MDD), or Directive 93/42 / EEC .
It is the most important regulatory instrument for demonstrating the safety and medical-technical performance of medical devices in the European Economic Area . It was last modified in large parts in 2007 via the amending directive 2007/47 / EC. These changes became legally effective in the EU on March 21, 2010.
On May 25, 2017, the new Regulation (EU) 2017/745 on medical devices came into force. This is also known as the Medical Device Regulation (MDR) and is valid without being implemented in national laws. With a transition period of 3 years it will replace the Medical Device Directive 93/42 / EEC.
As with all European directives, the primary goal of the Medical Devices Directive is to enable the free movement of goods. This is evidenced by Article 2 of Directive 93/42 / EEC, which requires:
"The member states shall take all necessary measures so that the products may only be placed on the market and / or put into operation if they meet the requirements of this directive when properly delivered, installed, maintained and used for the purpose for which they are intended."
The other articles deal with the administrative implementation and refer to further legal links.
The implementation of the Medical Devices Directive into national law is carried out by national laws, in Germany and Austria by the Medical Devices Act ( law on medical devices ). Switzerland, although neither a member of the European Union nor of the European Economic Area , also refers to this directive in the Therapeutic Products Act ( Federal Law on Drugs and Medical Devices ) and practically adopted it in the Medical Devices Ordinance (MepV) in April 1996 and implemented it in Swiss law.
Medical devices within the meaning of the directive
Medical devices within the meaning of the directive are all instruments, apparatus, devices, substances or other objects used individually or in combination, including the software used for the proper functioning of the medical device, which are intended by the manufacturer for human use for the following purposes:
- Detecting, preventing, monitoring, treating or alleviating disease;
- Detecting, monitoring, treating, alleviating or compensating for an injury or disability;
- Investigation, replacement or modification of the anatomical structure or a physiological process;
- Conception control,
and whose intended main effect in or on the human body is achieved neither by pharmacological or immunological agents nor metabolically, but whose mode of action can be supported by such agents. For the purposes of this guideline, accessories are treated as an independent medical product; other articles that are defined as medical devices are:
- Custom-made products according to medical specifications for certain patients,
- products intended for clinical trials on humans.
Excepted medical devices
The following medical products are not subject to Directive 93/42 / EEC:
- Active implantable medical devices (e.g. cardiac pacemakers ) are medical devices subject to Directive 90/385 / EEC
- As medical devices, in-vitro diagnostics are subject to Directive 98/79 / EC
- Fixed non-reusable units with a drug (drug kit)
- National exceptions for individual countries
The topic of the delimitation of different product groups is dealt with under product delimitation .
EU conformity assessment
The EU conformity assessment (Art. 11, Directive 93/42 / EEC) is carried out by the manufacturer. For higher risk classes (IIa, IIb and III) a notified body has to certify the conformity assessment (Art. 16 in conjunction with Annex XI, Directive 93/42 / EEC). The designation of the Notified Bodies corresponds to an accreditation and is carried out in Germany by the central office of the federal states for health protection for drugs and medical devices . The obligations of the notified body are listed in Annex XI of Directive 93/42 / EEC.
The manufacturer of a medical device must provide the authority with the address of the company headquarters, in the case of imports an authorized representative in the European Union , the description of the product in question, its designation, the areas of application, in the case of certificate requirements, its valid issuance by a notified body, the designation of a safety officer and prove his suitability prior to the intended market launch (Art. 14, Directive 93/42 / EEC).
Amendment Directive 2007/47 / EC
On March 29, 2007, the European Parliament approved the proposal to amend Council Directives 90/385 / EEC and 93/42 / EEC as well as Directive 98/8 / EC with a view to revising the directives on medical devices.
The amendment of Directives 90/385 / EEC, 93/42 / EEC and 98/8 / EC was published on September 5, 2007 with Directive 2007/47 / EC. The guideline came into force on September 25, 2007. The respective national implementations of the amending directive in the EU member states had to take place by December 21, 2008. In Germany, the Amendment Act of July 29, 2009 ( Federal Law Gazette I p. 2326 ) came into force on August 1, 2009 and January 1, 2013, respectively. On March 21, 2010, the national changes to EU Directive 2007/47 / EC came into force across the EU and have been applicable since then.
New European legal framework for medical devices from 2017
On May 5, 2017, Regulation (EU) 2017/745 of April 5, 2017 on medical devices (MDR) was published in the Official Journal of the European Union, which changes or repeals the previous directives and regulations.
In contrast to the previous situation in the form of directives , there will be no implementation in the national law of the individual member states in the future. Valid EU regulations represent directly valid law.
Following the adoption of the regulation in the first quarter of 2017 by the European Parliament and the Council and the publication in the Official Journal, the regulation according to Article 123 will enter into force on 25 May 2017. It will largely apply from May 26, 2021. Within the transition period that will apply until then, manufacturers can choose to be certified according to the old law (Directives 90/385 / EEC and 93/42 / EEC) or according to the new law (MDR) .
Since the Notified Bodies can be reappointed six months after the entry into force at the earliest in accordance with the requirements of the MDR in order to be able to carry out certification according to the new law (MDR), the transition period for the manufacturers is actually shortened - at least - by this period. When the "start of application" occurs (three years after the date of entry into force), the manufacturer's option ends.
However, old certificates issued in accordance with Directives 90/385 / EEC and 93/42 / EEC remain valid for a maximum of four years after the date of validity. Medical products can then be further manufactured and sold on this basis.
The MDR will be supplemented by further implementing and delegated EU legal acts in due course.
It is criticized that the MDR does not introduce an independent, state approval, that high-risk products can continue to be used without comprehensive clinical comparative studies and that data on incidents would probably not be published.
Web links
- Directive 93/42 / EEC in the consolidated version of October 11, 2007
- Directive 90/385 / EEC in the consolidated version of October 11, 2007
- Directive 98/8 / EC
- Directive 2007/47 / EC
- Communication from the Commission in the context of the implementation of Directive 93/42 / EEC (list of standards for the Medical Devices Directive) In: Official Journal of the European Union . Issue C 173 from May 13, 2016
- Regulation (EU) 2017/745 (MDR)
Individual evidence
- ↑ Directive 2007/47 / EC
- ↑ Erich Wintermantel, Suk-Woo Ha: Medical technology. Life Science Engineering . 5th edition. Springer, Berlin / Heidelberg 2009, ISBN 978-3-540-93935-1 .
- ↑ Proposal for a directive of the European Parliament and of the Council amending Directives 90/385 / EEC and 93/42 / EEC of the Council as well as Directive 98/8 / EC of the European Parliament and of the Council with a view to revising the directives on Medical devices (COM (2005) 0681 - C6-0006 / 2006 - 2005/0263 (COD))
- ↑ Gert H. Schorn: Changes to the law on medical devices - Caution: pay attention to the hidden EC law . In: Medical Devices Journal . tape 16 , no. 3 , September 2009, p. 163-175 .
- ^ Christian Baars, Elena Kuch, Britta von der Heide, Antonius Kempmann, Markus Grill, Arne Hell, Petra Blum: Research on medical products: Dangerous business with health. In: Tagesschau. ARD, November 25, 2018, accessed on November 25, 2018 .
