What is en 93 42 EEC?
The Medical Device Directive (Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, OJ No L 169/1 of 1993-07-12) is intended to harmonise the laws relating to medical devices within the European Union.
What does the Machinery Directive cover?
The Machinery Directive applies to machinery as well as interchangeable equipment, safety components, lifting accessories, chains/ropes/webbing, removable mechanical transmission devices, and partly completed machinery.
What is EC Certificate medical device?
What is CE marking? CE marking is the medical device manufacturer’s claim that a product meets the General Safety and Performance Requirements (GSPR) of all relevant European Medical Device Regulations and is a legal requirement to place a device on the market in the European Union.
Is MDR replacing MDD?
By Leslie Williams | April 2, 2021 MDR replaces the Medical Device Directive (MDD) that has been the standard for medical device regulation in the EU since 1993.
What is MDR certificate?
What is MDR certification? MDR certification of a medical device verifies that the device meets all of the regulatory requirements for European Union medical devices; the certification is indicated by a CE Mark. In order for medical devices to be certified, your company must implement a Quality Management System (QMS).
What does EC stand for in EC certificate?
“EC” is European Community – and is the term on older Directives that pre-date the New Legislative Framework (NLF) alignment. “EU” is European Union – and is the term on all Directive since around 2010.
Is EC Certificate same as CE?
It is a EC declaration of conformity. A CE declaration does not exist formally. However, a product consists of the product itself, a User manual and an EC declaration of conformity. In general, the EC declaration of conformity is also called a CE Statement or CE certificate.
How do I know if my CE certificate is real?
How to verify a CE certificate?
- Verify, whether this certificate can be verified online or not.
- Check if the certificate is referring to a technical file and its version.
- Verify if the certificate is referring to test report or not.
- Check if the certificate is referring to all applicable directive.
What is the difference between Directive 96/98/EC and 2014/90/eu?
Directive 2014/90/EU repealed Directive 96/98/EC on 18 September 2016. M.E.D. 96/98/EC is a Council Directive of 20 December 1996 of the European Commission (EC) in the European Union (EU). Several countries outside the EU area automatically approve and accept products with M.E.D. 96/98/EC authorisation.
What is the Marine Equipment Directive 96/98/EC?
Marine Equipment Directive 96/98/EC (also known as M.E.D. 96/98/EC and often called M.E.D/MED approval or certification in everyday language) is an authorisation of equipment and products for Marine industry. It is a Council Directive of 20. December 1996. Directive 2014/90/EU repealed Directive 96/98/EC on 18 September 2016.
What is the Commission Directive 97/69/ec?
Directive as last amended by Commission Directive 97/69/EC ( OJ L 343, 13.12.1997, p. 19 ). Council Directive 88/379/EEC of 7 June 1988 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations ( OJ L 187, 16.7.1988, p. 14 ).
When was the Last Time Directive 93/68/EEC was amended?
Directive as last amended by Directive 93/68/EEC ( OJ L 220, 30.8.1993, p. 1 ). OJ L 204, 21.7.1998, p. 37. Directive as last amended by Directive 98/48/EC ( OJ L 217, 5.8.1998, p. 18 ).