Regulation (EU) 2017/745 on medical devices
 Regulation (EU) 2017/745 |
|
|---|---|
| Title: | Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83 / EC, Regulation (EC) No. 178/2002 and Regulation (EC) No. 1223 / 2009 and repealing Council Directives 90/385 / EEC and 93/42 / EEC. |
| Designation: (not official) |
European Medical Device Regulation (MDR) |
| Scope: | EEA |
| Legal matter: | Environment, consumer and health protection |
| Basis: | TFEU , in particular Art. 114 and Art. 168 Para. 4 Letter c |
| To be used from: | Ordinance on medical devices from May 26, 2021 Ordinance on in vitro diagnostics from May 26, 2022 (with exceptions). |
| Reference: | Document 32017R0745 |
| Full text |
Consolidated version (not official) basic version |
| Regulation has entered into force and is applicable. | |
| Please note the information on the current version of legal acts of the European Union ! | |
The Regulation (EU) 2017/745 concerning medical devices came into force on 25 May 2017th It is also called the Medical Device Regulation ( MDR ) or the European Medical Device Regulation . It applies directly in the member states of the European Union and therefore does not have to be implemented in national law. However, extensive adjustments to national medical device law will be necessary. Regulation (EU) 2017/745 on medical devices replaces the medical device directives ( directive 93/42 / EEC on medical devices (MDD), directive 90/385 / EEC active implantable medical devices ( AIMD )). The Directive 98/79 / EC on in vitro diagnostic (IVD) will not rise-prescription medicine products in, but by their own new Regulation (EU) 2017/746 replaced ( In Vitro Diagnostic Medical Devices Regulation - iVDR ).
In contrast, the German Medical Devices Regulation is a regulation on the level of German law, which the Medical Devices Act (MPG) elaborates in more detail.
Content
Significant changes to the regulations include:
- Uniform naming and monitoring of the notified bodies on the basis of more specific and more stringent requirements,
- Creation of a coordination group ( Medical Device Coordination Group , MDCG) consisting of nominated experts from all member states,
- Introduction of an additional control procedure for the conformity assessment of the notified body for high-risk medical devices by an expert committee ( Scrutiny procedure ),
- Specification of the requirements for the clinical evaluation ,
- Detailed regulation of the procedure for the approval of clinical trials of medical devices and performance studies for in vitro diagnostics ,
- Tightening of the provisions on market surveillance and the vigilance system ,
- Regulation of the reprocessing of single-use products including the ban on reprocessing certain single-use products
- Improving the identification and traceability of products by introducing a unique product identification number (Unique Device Identification, UDI),
- Obligation of the manufacturer to provide coverage in the event of liability ,
- Expansion of the European database for medical devices and in vitro diagnostics (EUDAMED), some of which is to be made publicly available,
- New classification rules for software , products with nanomaterials and so-called material (note: medicinal product -like) medical products,
- Change in the classification rules for in-vitro diagnostics (IVDR), alignment with the four-class system for medical devices,
- Changes to the conformity assessment procedure for in-vitro diagnostics (including the integration of European reference laboratories in the assessment of in-vitro diagnostics of the highest risk class),
- Introduction of the concept of clinical evaluation of in vitro diagnostics.
implementation
In February 2017, the Federal Ministry of Health in Germany set up a "National Working Group for the Implementation of the New EU Regulations on Medical Devices (MDR) and In-Vitro Diagnostics" (NAKI), which solves implementation issues or uses EU Level should contribute. The NAKI is supported by seven sub-groups on the subjects of transitional regulations, notified bodies, manufacturer obligations, market surveillance, classification / delimitation and vigilance, clinical evaluation / clinical testing and processing.
In the course of the COVID-19 pandemic in 2020, EU Commissioner Stella Kyriakides announced that she would postpone the entry into force of the regulation by one year. In April 2020, the Parliament and the Council accepted the EU Commission's proposal . The date of application of the regulation was postponed to May 26, 2021. The original directives ( Directive 93/42 / EEC and Directive 90/385 / EEC ) remain in force until the new date of application. The postponement has no effect on the start of the ordinance on in vitro diagnostics, which will apply from May 26, 2022.
criticism
The representatives of small and medium-sized enterprises (SMEs), but also the large companies in the German medical technology industry, criticize the fact that the amended MDR provides for an additional review of the conformity assessment of the Notified Bodies by a further review committee. Germany was unable to assert itself with its criticism against the other EU states in the MDR legislative process. The Notified Bodies need hundreds, if not thousands, of specialists in order to be able to offer SMEs in particular the comprehensive regulatory services for their medical devices with a view to the MDR requirements, which are, however, lacking on the market. Manufacturers would therefore have to accept long waiting times before they obtain the necessary certifications in order to be able to bring innovative products onto the market, warned the industry associations Federal Association of Drug Manufacturers (BAV), Federal Association of the Pharmaceutical Industry (BPI), Federal Association of Medical Technology (BVMed) , German industry association for optical, medical and mechatronic technologies (Spectaris), Association of the German Dental Industry (VDDI) and Central Association of Electrical Engineering and Electronics Industry (ZVEI) on the occasion of the first anniversary of the entry into force of the new MDR. An extension of the applicable transition periods for the MDR and the amended IVDR as well as a significant reduction in the requirements for the recertification of proven existing products are required. It is also criticized 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
- Regulation (EU) 2017/745 Text of the European Medical Device Regulation (MDR)
- Text of the Medical Devices Regulation (Germany)
Individual evidence
- ↑ Medical Devices - New EU Regulations. In: bundesgesundheitsministerium.de. Federal Ministry of Health, October 12, 2018, accessed on March 14, 2019 .
- ^ The MDR 2017 - the most important changes. In: clinical-evaluation.report. Retrieved March 13, 2019 .
- ↑ Medical Device Regulation MDR - Medical Device Regulation (as of 2019). Johner Institute, December 3, 2018, accessed March 13, 2019 .
- ↑ NACI. Federal Ministry of Health, January 31, 2019, accessed on March 13, 2019 .
- ↑ EU wants to postpone medical device regulation by one year. In: Ärzteblatt. March 25, 2020, accessed March 26, 2020 .
- ↑ EU Commission wants to suspend MDR validity for one year. BVMed, March 25, 2020, accessed on March 26, 2020 .
- ↑ Regulation on medical devices: Commission welcomes support from the Council to give priority to the fight against the coronavirus. European Commission, April 23, 2020, accessed April 30, 2020 .
- ↑ New medical device regulation causes unrest. In: Ärztezeitung. August 6, 2018, accessed March 13, 2019 .
- ^ Christian Baars, Elena Kuch et al .: Research on medical devices: Dangerous business with health. In: Tagesschau. ARD, November 25, 2018, accessed on March 13, 2019 .
