What is CE MDD?
General. GPC can provide CE certification services through the cooperation of notified bodies. GPC’s nominated auditors can participate in the conformity assessment activities with notified bodies. The Medical Device Directive is intended to harmonize the laws related to medical devices within the European Union.
What is regulatory MDD?
History of the Medical Device Directive The Medical Device Directive – MDD – (Directive 93/42/EEC) was published in 1993. Its intention was: 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.
What does MDD and MDR stand for?
The EU has a few different regulatory requirements for medical devices. In Europe, there is the MDD (Medical Devices Directive) as well as MDR (Medical Device Regulation).
Does the MDD still apply?
Readers should be aware that “entry into force” isn’t the same as being applicable. The existing Medical Device Directive (MDD) remains applicable, as there will be a transition from the current MDD to the new EU MDR. The end of the transition coming for the final few devices, potentially as late as 27th May 2025.
How long is MDD valid?
The MDD CE certificate issued by SGS shows a five-year validity date (expiry date) and a recertification due date that is three years from issue. The recertification due date is linked to your ISO 13485 certification cycle (hence three years), which allow us to deliver combined audits.
What is the MDD 93/42/EEC?
Medical Devices Directive (MDD) 93/42/EEC – Explained 1 Devices must be designed and manufactured in such a way that when used under the conditions and for the purposes intended, they will not compromise the clinical conditions or 2 Safety principles, taking account of state of the art. 3 Benefits must outweigh the risks.
What is the Medical Device Directive 93/42/EWG?
Medical Device Directive 93/42/EWG (MDD) The MDD is the Medical Device Directive or 93/42/EEC. The number indicates the year of initial release (1993) and the consecutive number of directives in that year. European national states must translate this directive into national law.
Is Richtlinie 93/42/EWG still in force?
Richtlinie 93/42/EWG des Rates vom 14. Juni 1993 über Medizinprodukte No longer in force, Date of end of validity: 25/05/2021: This act has been changed. Current consolidated version: 11/10/2007 Richtlinie 93/42/EWG des Rates vom 14. Juni 1993 über Medizinprodukte
Was ist eine Richtlinie 89/391/ewg?
Die Richtlinie 89/391/EWG des Rates vom 12. Juni 1989 über die Durchführung von Maßnahmen zur Förderung einer besseren Sicherheit und Gesundheit am Arbeitsplatz (11) sowie die einschlägigen Einzelrichtlinien bleiben anwendbar.