MedPharmPlast Europe

MedPharmPlast Europe is a sector group of EuPC created in 2014 by and for companies involved in the whole supply chain of plastic medical devices and pharmaceutical packaging in Europe.

External news

FDA Formalizes UDI Compliance Deadline Extension for Low-risk Devices

Emergo Group Blog - Mon, 01/15/2018 - 17:42
EMERGO SUMMARY OF KEY POINTS: US FDA has published guidance setting new UDI compliance deadlines for some Class I and unclassified medical devices. The new deadlines were initially proposed in summer 2017.

UK Takes Stricter Stance on Human Factors Engineering for Medical Devices

Emergo Group Blog - Wed, 01/10/2018 - 21:22
EMERGO SUMMARY OF KEY POINTS: Human Factors Engineering (HFE) guidance from the UK MHRA differs in some areas from recommendations issued by the European Union. The MHRA focuses its recommendations on HFE and usability engineering during medical device development. In some areas, the MHRA guidance hews closer to US FDA recommendations than European standards.

Latest Chinese Medical Device Regulatory Changes Affect Clinical Trials, Testing, Telehealth

Emergo Group Blog - Mon, 01/08/2018 - 21:58
EMERGO SUMMARY OF KEY POINTS: Chinese medical device market regulators at the CFDA have published new and updated regulations covering clinical trial requirements, mobile medical technologies and device testing issues. The updates include technical guidance on clinical trial designs and mobile medical devices, as well as a notice on funding for local-level device testing centers.

New European Borderline and Classification Manual Published

Emergo Group Blog - Fri, 01/05/2018 - 21:31
EMERGO KEY POINTS: An updated version of the European Borderline and Classification Manual for medical devices and IVDs is now published. The latest manual will be of limited use once the European Medical Devices Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR) go into effect because of different definitions and classification rules.

Australian TGA Adopts Priority Review Approach for Medical Devices and IVDs

Emergo Group Blog - Thu, 01/04/2018 - 21:22
EMERGO KEY POINTS: New Australian TGA guidance establishes a priority review designation pathway for cutting-edge and novel medical devices and IVDs. Qualifying devices must meet criteria pertaining to serious diseases or conditions, unmet clinical needs and breakthrough technologies. TGA decisions on priority review designation applications will take no more than 20 business days.

Can Medical Robots Make Mistakes?

Emergo Group Blog - Wed, 01/03/2018 - 18:18
What is the likelihood of medical robots making mistakes on their own rather than because of human error?

Brazilian Regulators Establish Criteria for Marketing of Unregistered Medical Devices

Emergo Group Blog - Wed, 01/03/2018 - 16:41
EMERGO KEY POINTS: New Brazilian regulations list criteria for importing unregistered medical devices and health products into the country to address public health issues. Qualifying devices and products must be requested by the Brazilian Ministry of Health; requests are then reviewed by ANVISA.

Malaysian Regulators Extend Moratorium for Medical Device Registrations

Emergo Group Blog - Wed, 12/27/2017 - 20:12
EMERGO SUMMARY OF KEY POINTS: The Malaysian MDA will allow qualifying medical device market applicants to sell their products in the country pending full regulatory approval through June 2018. MDA registrants that submitted applications on or before June 30, 2016 qualify for the extended moratorium. Companies that submitted MDA registration applications after June 30, 2016 must obtain full regulatory approval before Malaysian commercialization.

It’s Back: Following Moratorium, US Medical Device Excise Tax (MDET) Returns in 2018

Emergo Group Blog - Wed, 12/27/2017 - 14:10
EMERGO SUMMARY OF KEY POINTS: The US Medical Device Excise Tax (MDET) will come back into effect in 2018. Manufacturers and importers of taxable medical devices will be subject to a 2.3% tax on US sales. Years-long MDET repeal efforts by industry and Congressional allies have so far not succeeded.

US Regulators Refine Least Burdensome Provisions for Medical Device Oversight

Emergo Group Blog - Fri, 12/22/2017 - 15:41
EMERGO SUMMARY OF KEY POINTS: US FDA has updated guidance on how least burdensome provisions are applied to medical device registration and oversight. The new guidance applies across all aspects of FDA medical device regulation. The FDA’s least burdensome approach may lead to less onerous US market authorization requirements for some manufacturers.

European Internet of Things Cybersecurity Recommendations: Impact for Medical Devices

Emergo Group Blog - Tue, 12/19/2017 - 02:53
EMERGO SUMMARY OF KEY POINTS: European regulators have published high-level cybersecurity recommendations for industries including medical devices involved in the Internet of Things (IoT) paradigm. The recommendations are partially intended to help companies meet upcoming European data privacy requirements under the General Data Protection Regulation, or GDPR. The European report cites US FDA guidance regarding medical device cybersecurity principles and recommendations.

Final Guidance from US FDA on Clinical Evaluation of Software as a Medical Device (SaMD)

Emergo Group Blog - Mon, 12/18/2017 - 19:37
EMERGO SUMMARY OF KEY POINTS: US FDA final guidance on clinical evaluation of software as a medical device (SaMD) is now published. The guidance utilizes SaMD clinical evaluation principles and recommendations issued by the International Medical Device Regulators Forum (IMDRF). US regulators intend to use this guidance as a basis for developing more specific SaMD clinical evaluation guidance in the future.

US Regulators Lay Out Medical Device, IVD Guidance Priorities for 2018

Emergo Group Blog - Wed, 12/13/2017 - 00:05
EMERGO SUMMARY OF KEY POINTS: The US FDA’s Center for Devices and Radiological Health (CDRH) unit has publicized plans for medical device and IVD guidances over the next year. High-priority areas of focus for CDRH in 2018 include 510(k) third-party reviews and abbreviated pathways, Unique Device Identification (UDI) deadlines for low-risk devices and device accessory classification. Not all planned CDRH guidance documents will be published due to resource allocation and other regulatory obligations.

US FDA Rolls Out Trio of Digital Health and Medical Software Guidances

Emergo Group Blog - Fri, 12/08/2017 - 22:15
EMERGO SUMMARY OF KEY POINTS: US FDA has issued three new guidances focused on digital health technology regulations. The guidances stem from 21st Century Cures Act requirements for timelier registration processes for digital medical technologies.

Designing Effective Warnings for Medical Devices

Emergo Group Blog - Wed, 12/06/2017 - 18:47
EMERGO SUMMARY OF KEY POINTS: Medical device warnings require careful design and communication considerations. Manufacturers should heed warning sign conventions such as signal words. Warnings are not foolproof, but are a necessary component for medical device risk mitigation. Some people believe that warnings are useless; printed on medical devices only to offer legal protection. Indeed, manufacturers can and have been held liable for the “failure to warn,” and adding warnings neutralizes this claim.

In Brief: New China FDA Guidance on Medical Device Registration Grouping

Emergo Group Blog - Tue, 12/05/2017 - 21:14
EMERGO SUMMARY OF KEY POINTS: Final guidance from China Food and Drug Administration (CFDA) on medical device registration grouping criteria First CFDA update on registration grouping guidance since March 2015

Final US FDA Guidance for Additive and 3D Printed Medical Device Manufacturers

Emergo Group Blog - Tue, 12/05/2017 - 16:22
EMERGO SUMMARY OF KEY POINTS: US FDA final guidance issued for additive manufacturing and 3D printed medical devices Final guidance hews closely to draft version US regulators planning larger effort to develop regulatory framework for 3D printed devices

New US FDA Guidance: How to Utilize the Dual 510(k) and CLIA Waiver IVD Market Pathway

Emergo Group Blog - Fri, 12/01/2017 - 22:03
EMERGO SUMMARY OF KEY POINTS: New FDA recommendations issued for IVD manufacturers using the Dual 510(k) and CLIA Waiver by Application registration pathway. The FDA’s Dual Submission pathway allows IVDs to reach the US market faster than if registrants obtain 510(k) clearance and then CLIA waived categorization in a stepwise process. The Dual Submission registration pathway is best suited for simple IVDs  subject to 510(k) rather than Premarket Approval (PMA) review.

European NBOG Designation Codes for Notified Bodies Officially Released

Emergo Group Blog - Mon, 11/27/2017 - 17:03
EMERGO SUMMARY OF KEY POINTS: Notified Body designation codes for the Regulations are now officially released. There are some minor differences in the list for medical devices. The list for IVDs has been reduced by 20 codes. Manufacturers can now list the NBOG codes that are relevant for them.

New Harmonized Medical Device, IVD Standards Published in Europe

Emergo Group Blog - Wed, 11/22/2017 - 01:24
EMERGO SUMMARY OF KEY POINTS: European regulators have published updated harmonized standards applicable to the Medical Device Directives in the Official Journal of the European Union. The updated list of standards replaces the EN 980 labeling standard with EN ISO 15223 starting in early 2018. The European list of harmonized standards was last updated in May 2016.

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