An Overview of Recent Developments in the European Regulation of Medicine/Medical Device Combination Products

Drug Information Journal

Volumn 37, Issue 1, 2003, Pages 39-43

  Jefferys, David B ^a  

^a Medical Devices Agency   (United Kingdom)

Author keywords

Combination products; Drug delivery systems; Harmonisation; Medical device regulations; New approach directives; Theranostics; Tissue engineering

Indexed keywords

DEVICE; EUROPE; LAW; MEDICAL INSTRUMENTATION; PRACTICE GUIDELINE; PRIORITY JOURNAL; REVIEW; TECHNOLOGY; TISSUE ENGINEERING;

EID: 0142246391     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286150303700107     Document Type: Review

References (10)

1. Jefferys DB. The regulation of medical devices and the role of the Medical Devices Agency. Br J Clin Pharmacol. 2001;52:229-235.
2. Jefferys DB. Comparison of the regulatory controls for medical devices and medicinal products. Int J Pharm Med. 2001;15:125-130.
3. Guideline for the Clarification of Medical Devices MEDDEV 2.4/1 Rev 07-2001.
4. Council Directive 93/42/EEC of June 1993.
5. 2001/83/EC Directive of the European Parliament and of the Council of November 6, 2001. 2001 in the Community Code Relating to Medical Products for Human Use OJEC L311.
6. Directive 200/70 EC of 16 December 2000 OJEC L313 of 13.12. 2000 as last amended by Directive 2001/104 EC.
7. Council Directive 90/385 EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices 4 189. July 20, 1990.
8. Opinion on the state of the art concerning tissue engineering. Doc. SANCO/SCMPMD/2001/0006.
9. Council Directive 98/79 EC of the European Parliament and of the Council of the 27 October 1998 on in vitro diagnostics medical devices L331. December 7 1998.
10. A code of practice for tissue banks-providing tissues of human origin for therapeutic purposes. Department of Health; 2001: ISBN 1. 84182, 231,5.