COVER LETTER PSUR

Annual summary reports are to be submitted when requested by Health Canada. The document is divided into sections identifying the key issues for the development of further guidance. Not only is PMS defined in Article 2 60 , it is listed as one of the general obligations of all manufacturers new Article 10 , it is also one of the topics specifically called out for monitoring by the person responsible for regulatory compliance new Article In addition, Section C. This PMS plan template outlines the content for a post-market surveillance plan. The repository will act as the single point for all submissions including responses and supplementary information.

For example, the regulation distributes requirements through a series of interlocking articles and annexes. Gap assessmen t b etw een you r ex istin g d esign d ocu men ts e. Irish Medtech Skillnet in association with Meddev Solutions Limited are delighted to offer a 2-day overview and application of the Medical Device Regulation. April 9, Our file number: Not only is PMS defined in Article 2 60 , it is listed as one of the general obligations of all manufacturers new Article 10 , it is also one of the topics specifically called out for monitoring by the person responsible for regulatory compliance new Article The annual summary report shall contain a concise, critical analysis of the adverse drug reactions and serious adverse drug reactions to the drug.

cover letter psur

By introducing new roles and responsibilities for all economic operators, the MDR now combines all necessary elements in a single legislation. The guidance clarifies that usability engineering is an iterative process, involving design, testing and validation of design stages; it also requires attention to the post-market phase, since evidence may come to light while a device is being used in clinical practice that the design requires further improvement.

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In accordance with the Food and Drug Regulations, in preparing the annual summary report, if the MAH concludes that there has been a significant change in what legter known about the risks and benefits of the health product, the MAH must notify Health Canada in writing without delay see Health Canada contact information provided in Appendix A.

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In their General Approach Art.

Periodic Safety Update Reports (PSURs)

These documents are regularly updated. It is possible that a PSUR could be submitted as part of the PSUR Worksharing procedure while at the same lettrr it is also part of an application for re-registration or renewal of a registration. A Periodic Safety Update Report is a pharmacovigilance document intended to provide an evaluation of the risk-benefit balance of a medicinal product at defined time points post-authorisation.

Under the MDR, many devices will be re-classified to a higher device class, impacting their clinical data requirements. The legislation introduces the principle of EU single assessment where a substance is authorised in more than one Member State. The date of application for the MDR is fast approaching. In preparing the annual summary report, the manufacturer shall determine, on the basis of the analysis referred to in subsection 2whether there has been a significant change in what is known about the risks and benefits of the drug during the period covered by the report and shall include its conclusions in this regard in the summary psu.

cover letter psur |

This article explains how to write a post-market surveillance plan for CE Marking and how to determine if a post-market clinical follow-up PMCF study is required. A link, button or video is not working. Please follow the procedures outlined in this Notice until such a time as otherwise notified.

The new EU MDR is very prescriptive and eliminates many of the grey areas and subjective interpretation that companies dealt with under the previous directive.

cover letter psur

NSF International hosted an industry forum in the UK on November 30,to explore the likely impact of the changes on company planning, finance and human resources, particularly in the areas of quality assurance, regulatory and manufacturing functions. Belongs to Veterinary medicines.

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PSUR worksharing

However, some differences exist. Here is a map of the EU: As the MDR gives particular attention to risk management, we have asked our Medical Device experts to look closely at the new requirements in this field. Following this short trip to India, we would like to consecrate ourselves to the European PSUR in detail as there are also sufficient abbreviations for potentially causing confusion. There are several changes in this new regulation. Are Pharmaco- and Medical Device Vigilance the same?

Periodic Safety Update Reports (PSURs)

Total product lifecycle management is assumed, emphasizing safety backed by clinical data. Duplicate copies are not required.

cover letter psur

EU-wide standardisation of the test certificates issued by the notified bodies — MDR certificate; introduction of a mechanism for scrutiny: Too many levels of bookmarks are inefficient; in most instances, four levels of bookmarks should be sufficient: D esi gn D oc um ent Gap A ssessm ent: Share this page Twitter Facebook LinkedIn.

For more information, please see our MDR transition webpage. Under the current regulatory framework for annual summary reporting, Health Canada may request additional information on a case-by-case basis or in follow-up to a PBRER review. The following are recommended as good bookmarking practices:.

The naming convention used for the leaf titles is up to the MAH’s discretion; however, meaningful names should be applied. The EU-MDR enforces reducing risk to patients and creates a way to track each device from the manufacturer to the patient. The plan identifies the process and letteg of activities for gathering post-market data as an input into clinical evaluations and risk analysis to be included in your technical documentation for a medical device CE Marking application.

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