openPR Logo
Press release

Update on the New EU Medical Device Regulation and In Vitro Diagnostic Regulation

04-07-2017 09:06 AM CET | Business, Economy, Finances, Banking & Insurance

Press release from: SGS

/ PR Agency: Sugarloaf Marketing
Update on the New EU Medical Device Regulation and In Vitro

Eudamed, the European Database on Medical Devices, has published a timetable for the expected completion of legislation towards an amended Medical Device Regulation (MDR) and In Vitro Diagnostic Regulations (IVDR). According to the timetable, an official version of the new MDR and IVDR will probably be published in May 2017.

As part of this process, Eur-lex released the final draft of the amended MDR and IVDR on February 22, 2017. The drafts include instructions on the chemical requirements in the new regulations – in sections 10.4.1 and 10.4.5 of the draft MDR and section 10.3 in the draft IVDR. The MDR also contains special guidelines on phthalates and CMR or endocrine disruption substances.

The draft MDR also states that a label will be necessary if a device, part or material contains CMR 1A, 1B or EDCs in a concentration higher than 0.1% (w/w). In addition, instructions for use must be given as a precautionary measure if the device is intended for use by a patient group who may be considered particularly vulnerable to substances and/or materials within the device. The draft legislation singles out children and pregnant or breastfeeding women as vulnerable groups.

The full timetable, as released by Eudamed, is:

• End January 2017 – English version of the new MDR and IVDR
• Middle of February 2017 – English version and EU translations distributed to stakeholders
• Beginning of March 2017 – Council expected to accept the new versions
• Beginning of April 2017 – European Parliament adopts regulations
• End April 2017 – Formal publication
• End May 2017 – Official entry into force
• End May 2020 – MDR applicable
• End May 2022 – IVDR applicable

The revision and creation of a new European MDR and IVDR has been in discussion since 2012. It is expected that the official versions will enter into force in May 2017. This will create an applicable date of May 2020 for the new MDR, and 2022 for the new IVDR.

Stakeholders are advised to now consider the updated regulations to check their future compliance.

SGS Medical Devices Services
SGS’s medical device testing, certification, audit and training services help companies navigate the complexities of international medical device regulations to bring their products to market quickly whilst ensuring compliance with the required regulations and standards. Learn more about SGS’s Medical Devices Services (www.sgs.com/consumermedicaldevices)

SGS SafeGuardS keep you up to date with the latest news and developments in the consumer goods industry. Read the full Eudamed Releases Timetable to Update the EU’s Medical Device Regulation and in Vitro Diagnostic Regulation SafeGuardS. (www.sgs.com/en/news/2017/03/safeguards-04517-eudamed-releases-timetable-to-update-the-eu-medical-device-regulation)

Subscribe here, www.sgs.com/subscribesg, to receive SGS SafeGuardS direct to your inbox.

For further information contact:

Richie Chang
SGS Taiwan Ltd. Multi-Chemical Lab (Taipei) Asst. Manager
Tel: +886 2 22993279
Email: cts.media@sgs.com
Website: www.sgs.com/ee

About SGS
SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 90,000 employees, SGS operates a network of over 2,000 offices and laboratories around the world.

1, Mons Calpe
Chitcombe Road
Broad Oak
Rye
East Sussex
TN31 6EU

This release was published on openPR.

Permanent link to this press release:

Copy
Please set a link in the press area of your homepage to this press release on openPR. openPR disclaims liability for any content contained in this release.

You can edit or delete your press release Update on the New EU Medical Device Regulation and In Vitro Diagnostic Regulation here

News-ID: 494708 • Views: 372

More Releases from SGS

Ecuador Issues Revised Draft Technical Regulation on Food Contact Ceramics
Ecuador has announced a revised proposal that, if accepted, will update its technical regulation for food contact ceramics. The latest proposal, designated Ecuadorian Technical Regulation RTE UNEN 010 (2R) – ‘Ceramic Tableware Intended to Come into Contact with Food’, was circulated attached to World Trade Organization (WTO) document no. 20-4675 on July 8, 2020. It has a new structure and contains several important changes, including: • Revision to existing definitions and
SGS puts Consumer Trust at the Heart of its new Brand Awareness Campaign
SGS, the world’s leading inspection, testing and certification company, has today launched ‘Trusted. Tested.’ – a high impact, brand awareness campaign to engage consumers in the vital role of testing, inspection and certification on the everyday products they purchase. With the strapline ‘It’s only trusted because it’s tested’, the campaign showcases more than 50 everyday products that typically pass through SGS’s testing laboratories – from lipsticks and shoes to mobile phones
SGS Guides Manufacturers Through Categorization of Medical and Personal Care Pro …
SGS, the world's leading provider of testing, verification and certification services, offers a comprehensive range of services to help manufacturers of products aimed at assisting the elderly ensure they are safe and comply with the relevant regulations. We live in a world with an aging population. Currently there are an estimated 143 million people over 80, but this figure is expected to triple to 426 million by 2050. These
Multiple Prop 65 Agreements on DINP in Consumer Products Reached in California
In recent months, several California Proposition 65 (Prop 65) settlement agreements and judgements have been reached in relation to the use of diisononyl phthalate (DINP) in various consumer products. Prop 65, the 'Safe Drinking Water and Toxic Enforcement Act of 1986', is a unique piece of legislation that passed overwhelmingly by a ballot of Californian residents in November 1986. It is a right-to-know law that requires the state to publish

All 5 Releases


More Releases for MDR

Managed Detection and Response (MDR) Market – Growth Opportunities & Technolog …
MarketResearchReports.Biz announces addition of new report "Managed Detection and Response (MDR) Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2017 - 2025" to its database. The objectives of this study are as follows: To define, describe, and forecast the "Managed Detection and Response (MDR)" market by type, application, component, delivery model, end user, and region To provide detailed information regarding major factors influencing market growth (drivers, restraints, opportunities, and industry-specific
Managed Detection and Response (MDR) Market - Global Industry Share, Growth, Tre …
Managed detection and response (MDR) improves incident response capabilities and threat detection monitoring through a turnkey approach which detects threats that have evaded other controls. Risk and security management providers are understanding the importance of MDR services and its impact for their environments. New service providers have developed solutions to support businesses seeking to increase their incident response and threat detection capabilities. Additionally, MDR vendors deliver services for purchasers looking
Indian Retail Industry Poised for Big Growth Post MDR Withdrawal
Chennai, December 27, 2017: Come January 2018, retailers can rejoice as they don’t need to pay Merchant Discount Rate (MDR) charges to banks for every debit card payment they receive. The government’s recent decision to abolish MDR for small and medium retail merchants over the digital transactions through debit card up to Rs 2000 has come as a welcome relief for thousands of retail businesses across the country as they were
Managed Detection and Response (MDR) Market Investment Research Report 2025
Managed detection and response (MDR) improves incident response capabilities and threat detection monitoring through a turnkey approach which detects threats that have evaded other controls. Risk and security management providers are understanding the importance of MDR services and its impact for their environments. New service providers have developed solutions to support businesses seeking to increase their incident response and threat detection capabilities. Additionally, MDR vendors deliver services for purchasers looking
Managed Detection and Response (MDR) Market Industry Analysis, Trend and Growth, …
Managed detection and response (MDR) improves incident response capabilities and threat detection monitoring through a turnkey approach which detects threats that have evaded other controls. Risk and security management providers are understanding the importance of MDR services and its impact for their environments. New service providers have developed solutions to support businesses seeking to increase their incident response and threat detection capabilities. Additionally, MDR vendors deliver services for purchasers looking
Practical checklist of changes to comply with new Medical Device Regulation (MDR …
Maetrics reveals the practical implications for medical device manufacturers and how to address them as the new MDR comes into force June 2017 - Agreement has at last been reached on the new European Medical Device Regulation (MDR), which officially came into effect in May 2017. The new regulation has consolidated two existing legal provisions and replaced both the current Medical Device Directive (93/42/EEC) and the Active Implantable Medical Device Directive