Medical Device Directive Update

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Medical Devices | FDA - U.S. Food and Drug Administration

https://www.fda.gov/Medical-Devices

Medical Device Updates CDRH 2022 Annual Report Accomplishments for 2022, including the Pandemic Response, MDUFA V, Device Innovation, over-the-counter (OTC) hearing aid final rule, and device safety.

Medical Devices - Sector - Latest updates - Public Health

https://health.ec.europa.eu/medical-devices-sector/latest-updates_en

Medical Devices - Sector - Latest updates. MDCG 2021-22 rev.1 - Clarification on “first certification for that type of device” and corresponding procedures to …

Medical devices | European Medicines Agency

https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices

The medical device may be co-packaged with, obtained separately from or integral to the medicinal product. EMA issued a final guideline on quality documentation …

The European Union Medical Device Regulation – …

https://eumdr.com/

Update of Manual on borderline and classification under Regulations ... MDCG 2020-5 on Clinical Evaluation – Equivalence and MDCG 2020-6 on Clinical evidence needed for …

MDR vs. MDD: 13 Key Changes - The FDA Group

https://www.thefdagroup.com/blog/mdr-vs-mdd-13-key-changes

The new regulation is four times longer, and contains five more annexes than its predecessor, the Medical Device Directive (MDD).; The word "safety" appears 290 …

MDR Medical Device Regulation medical …

https://www.bsigroup.com/en-GB/medical-devices/our-services/MDR-Revision/

The European Medical Device Regulation (MDR) replaced the MDD and the AIMDD and entered into force on 25 May 2017 with 26 May 2021 as date of application. On 27 May …

Medical devices - Internal Market, Industry, Entrepreneurship and …

https://single-market-economy.ec.europa.eu/single-market/european-standards/harmonised-standards/medical-devices_en

Short name: Medical devices. Base: Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, …

Medical Devices Directive 93/42/EEC is due …

https://www.cti-cem.com/blog/medical-devices-directive-93-42-eec/

The Medical Devices Directive is due to be replaced by the Medical Devices Regulation in 2021. The main differences between the Directive and the Regulation are as follows: …

Medical Devices Directive - Wikipedia

https://en.wikipedia.org/wiki/Medical_Devices_Directive

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 …

New UK MHRA Medical Devices Regulations Published - NAMSA

https://namsa.com/uk-mhra-medical-device-regulations-published/

On 26 June 2022, the United Kingdom’s Medical Devices and Healthcare Regulatory Authority (MHRA) published the results and conclusions from the consultation …

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