Is 93 42 EEC still valid?
Regulatory requirements for medical devices From May 26, 2021, the EU Medical Device Regulation, (MDR (EU) 2017/745) has replaced the EU’s Medical Device Directive (93/42/EEC). Click here for more information about the Medical Device Regulation.
What is EC certificate for 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.
What is MDD certificate?
The Medical Devices Directive (MDD) applies to all general medical devices not covered by the Active Implantable Medical Devices Directive or the In vitro Diagnostic Medical Devices Directive. In order to obtain medical device approval in the EU, medical devices must be correctly classified.
What is regulatory MDD?
The Medical Device Directive – MDD – (Directive 93/42/EEC) was published in 1993. to harmonise the laws and standards relating to design and manufacturing medical devices within the European Union. to ensure that medical devices are safe for patients.
Can you sell without CE Mark?
Not all products must bear the CE marking. CE marking does not mean that a product was made in the EEA , but states that the product is assessed before being placed on the market. It means the product satisfies the legislative requirements to be sold there.
What is meant by CE certification?
The CE mark means that the manufacturer takes responsibility for the compliance of a product with all applicable European health, safety, performance and environmental requirements. CE stands for “Conformité Européenne”, the French for European conformity.
Is MDR replacing MDD?
On 26 May, 2021, the Medical Device Directive (MDD) will be replaced by the new Medical Device Regulation (MDR). This allows MDR to provide a regulation which is consistent and fair to all member states, increasing the standards on quality and safety measures.
What’s the difference between MDD and MDR?
The MDR is significantly more comprehensive and detailed compared to the MDD. While the MDD comprises 23 Articles and 12 annexes over 60 pages, the MDR has 123 articles and 17 annexes over 175 pages. The scope of the MDR is wider than that of the MDD.
How do I know if my CE certificate is valid?
Today, there is no central database over CE marks or notified body certificates. The only way to check a CE mark is to validate the documentation, i.e. the Technical File and Declaration of Conformity. There is no such thing as a “CE certificate” or a “CE mark certificate”, there are only notified body certificates.
What are the requirements of Directive 93 / 42 / EEC?
Conformity with the requirements of the EU regulations for medical devices and the legislation is proved by the granted EC Certificate. ISO 13485 is a harmonized standard applied by the manufacturers of medical devices to prove the compliance of the quality system with the requirements of Directive 93/42/EEC.
How are medical devices classified according to EEC?
Classification of medical devices? According to the current legislation there is followed classification of medical device in accordance with annex IX if the directive 93/42/EEC, which divide medical devices into Classes I, I with measuring function, I sterile, IIa, IIb and the highest risk class III.
What makes an EC certificate valid for a medical device?
The EC certificate is valid as long as you can prove that you still comply with the requirements of the ISO 13485 standard by means of annual audits. The conformity assessment procedure of a medical device depends on the classification of the medical device/class and the related degree of risk for users and the manufacturer’s decision.
How often does an EC Certificate need to be audited?
The audit under the Medical Device Directive can be combined with the audit under the ISO 13485 standard. After granting the EC certificate and the certificate according to ISO 13485, we conduct annual surveillance audits of individual parts of the system to check the operation of the system and a re-assessment audit every three years.