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

Brazilian ANVISA Clarifies Local, Federal Level Medical Device Oversight Responsibilities

Emergo Group Blog - Fri, 02/16/2018 - 20:21
EMERGO SUMMARY OF KEY POINTS: ANVISA has formally mapped out medical device regulatory responsibilities at its federal, state-level and local branches. Under RDC 215/2018, ANVISA oversight responsibilities and structures currently in place are mostly kept as is.

Emergo Survey: Regulatory Challenges Having Bigger Impact on Smaller Medical Device Companies

Emergo Group Blog - Thu, 02/15/2018 - 16:40
EMERGO SUMMARY OF KEY POINTS: Regulatory challenges are affecting larger percentages of both large and small medical device companies heading into 2018, according to a new Emergo survey. In previous years, small and startup companies were more concerned with funding and capital issues than regulatory challenges. Product development, pricing pressure and funding challenges also ranked highly in our 2018 survey.

UDI for Medical Devices Going Global

Emergo Group Blog - Wed, 02/14/2018 - 15:53
EMERGO SUMMARY OF KEY POINTS: Most markets all over the world will have a system for Unique Device Identification within five years. It will likely be possible to have a single code on each device for all these markets. It is likely that those codes will be linked to different databases for each market. In March 2018 the European Commission will publish a guidance document on UDI under the MDR and IVDR.

Chinese Regulators Issue Near-Term Plan for Medical Device Standards Development

Emergo Group Blog - Fri, 02/09/2018 - 15:51
EMERGO SUMMARY OF KEY POINTS: Chinese regulators plan to develop new medical device standards over a two-year period. The standards will cover risk management, quality and clinical trials, and align with international standards, according to CFDA. CFDA will also hire up to 200 additional staff to support standards development.

China FDA Two-track Medical Device Testing Policy May be Coming

Emergo Group Blog - Wed, 02/07/2018 - 18:15
EMERGO SUMMARY OF KEY POINTS: The China Food and Drug Administration (CFDA) may soon launch a two-track in-country testing pathway for medical devices. A possible commission testing option would cost registrants a fee but allow a potentially faster testing process. No official CFDA rollout of the new testing policy has occurred yet.

8 Key Steps to Delivering Effective, In-person Medical Device Training

Emergo Group Blog - Tue, 02/06/2018 - 19:56
For some medical devices used in clinical and home environments, end-users are the benefactors of formal training designed to facilitate safe and effective device use. However, not all medical device training programs are created equal.

FDA Updates PMA and 510(k) Refuse to Accept Policy for Combination Products

Emergo Group Blog - Tue, 02/06/2018 - 18:15
EMERGO SUMMARY OF KEY POINTS: US FDA has updated its 510(k) Refuse to Accept and Premarket Approval acceptance policies for combination product submissions. The updated guidances include new requirements for drug patent and exclusivity information.

In Brief: US Legislators Put Medical Device Tax Back on Ice

Emergo Group Blog - Tue, 01/30/2018 - 21:59
US lawmakers have delayed reestablishing the Medical Device Excise Tax (MDET) by another two years as part of a short-term government funding arrangement.

New Training Course on UL Medical Device Cybersecurity Standard Set for April 2018

Emergo Group Blog - Thu, 01/25/2018 - 20:14
UL’s Health Science Digital Health division will conduct a two-day training course on the company’s cybersecurity standard for medical devices in April 2018 in Denmark.

Brazil’s ANVISA Doubles Validity Timeframes for High-Risk Medical Devices and IVDs

Emergo Group Blog - Thu, 01/25/2018 - 14:48
EMERGO SUMMARY OF KEY POINTS: ANVISA has extended Class III and IV medical device and IVD registration validity times from five to 10 years. These changes have already gone into effect in Brazil. ANVISA registrants that have already obtained registration renewals will automatically qualify for the extended validity timeframe.

Brexit: The Hard Reality of “No Deal” for the Medical Device Industry

Emergo Group Blog - Wed, 01/24/2018 - 17:03
EMERGO SUMMARY OF KEY POINTS: All economic operators in Europe, the UK and in the rest of the world may face significant consequences of Brexit. The distribution network of medical devices currently placed on the market by UK based importers must be reviewed. EU distributors currently placing UK manufactured devices on the market may have a different role. Unless a fitting deal has been made, all certificates issued by British Notified Bodies on EU regulations/directives will become void from 30 March 2019. Notified Bodies are already anticipating this scenario.

Europe: Development of Eudamed well on schedule

Emergo Group Blog - Mon, 01/22/2018 - 18:24
EMERGO SUMMARY OF KEY POINTS: Eudamed functional specifications expected to be released in May of this year Eudamed expected to go live in March 2020 As with all plans: there are some uncertainties regarding the execution of this plan

Brazil’s ANVISA Streamlines Medical Device Importation Processes

Emergo Group Blog - Fri, 01/19/2018 - 17:25
EMERGO SUMMARY OF KEY POINTS: A new ANVISA resolution has simplified medical device importation requirements for Brazil. Imported devices no longer have to undergo inspections at Brazilian points of entry. Additional changes to simplify ANVISA importation requirements are anticipated in the near future.

US FDA Delays Contentious Medical Device Intended Use Rule

Emergo Group Blog - Wed, 01/17/2018 - 21:34
EMERGO SUMMARY OF KEY POINTS: US FDA has indefinitely delayed new requirements for evidence used to determine intended use. The intended use-related requirements are part of a larger final rule covering tobacco products that fall under US medical device regulations. The other parts of the final rule will go into effect in March 2018.

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?

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