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How will medical devices be regulated after 1 January 2021?
On 1 September 2020, MHRA laid out the future UK requirements for placing medical devices on the UK market after the end of the Brexit transition period at the end of 2020. Our devices team have summarised the key elements of the MHRA guidance applicable from 1 January 2021 and highlighted key actions to be taken by devices manufacturers to maintained their devices on the UK and EU markets.
Navigating the regulatory submission process for a class III medical device with ancillary medicine
This whitepaper will help you understand if your product is classified as a medical device with an ancillary medicine as well as help direct the correct regulatory process for submission and approval.
The Medical Device Regulations and Their Implications on Device Vigilance
This Whitepaper will discuss the safety or vigilance implications of these new regulations.
MDR - Implementation Is Delayed - What Has Changed?
This whitepaper summarises the implementation status of different areas subject to major changes under the MDR. Check back for continuous updates on the MDR state of play.
Considerations When Applying for a Generic Medicine Authorisation
This whitepaper details the key considerations to be made when making an application for a generic medicine authorisation.
Medical Device Software and Mobile Apps
An informative whitepaper on the growing area of interest in medical device software and mobile applications.
Legal Status Switches in the UK - How to avoid some common mistakes
For switches of legal status of a medicine from prescription only (POM) to pharmacy (P) or P to general sales list (GSL), this whitepaper will give you some great tips on how to avoid common mistakes.
Hot regulatory and pharmacovigilance topics for 2020
As 2019 comes to a close, Regulis’ MD Kim Wharton provides a few thoughts on some hot topics for the year ahead.
EU Clinical Trial Regulation
This whitepaper provides a detailed insight into the incoming EU Clinical Trial Regulation, and the past, present and future challenges associated with establishing the new regulations.
Pharmacovigilance preparations in the event of a ‘no deal’ Brexit
This whitepaper tells you about your pharmacovigilance related obligations along with some guidance in the event of a 'no-deal' Brexit situation.
How will medicines be regulated if the UK leaves the EU?
If you have a medicinal product on the market in the UK, an application for medicinal product which involves the UK or are developing a medicinal product intended for the UK, read our latest whitepaper on your obligations and some guidance in a 'no-deal' Brexit situation.
How will medical devices be regulated, if the UK leaves the EU without a deal?
If you are a manufacturer, authorised representative, importer or distributor of medical devices based in the UK, or market your medical devices in the UK, read our latest whitepaper on your obligations after Brexit in a no-deal situation.
EU Drug Registration Procedures
This whitepaper provides a high level narrative into the possible procedures into obtaining a Marketing Authorisation (MA) for a medicinal product in the European Union. It gives a brief overview of the timelines involved in each procedure as well as information on the EU’s allowance for data exclusivity.
Monitoring Compliance with Safety Exchange Agreements
Monitoring of compliance via a safety data exchange agreement (SDEA) or pharmacovigilance agreement (PVA) is vital in order to ensure that regulatory requirements are being met. In this whitepaper, we describe the importance of these agreements and the organisations that are required to maintain them.
Implementation of Eudravigilance Data Analysis System (EVDAS) in signal detection
This whitepaper discusses the requirements of analysing Eudravigilance data for signal management, including the new EVDAS system. Find out MAH responsibilities, how to implement the information and what to expect from the EM.
Time to change the Rules!
The release of the MDR and the IVDR, brings some significant changes to the Classification Rules for Medical Devices and In-Vitro Diagnostics. This will affect a lot of devices and their manufacturers. Find out how your device could be affected in this whitepaper.
Preparing for a Good Pharmacovigilance Practice MHRA Inspection
If you are currently preparing for a Good Pharmacovigilance Practice (GPvP) Medicines and Healthcare products Regulatory Agency (MHRA) inspection, or would like to be prepared in case of an unannounced inspection, then this whitepaper provides valuable guidance on what to expect and how to prepare for the inspection. This whitepaper also highlights common critical and major findings from MHRA GPvP inspections.
Preparing to change your European Notified Body
We are more than half way through the Medical Device Regulation (MDR) transition period (Date of Application 26th May 2020), but unfortunately not all Notified Bodies will be in a position to be designated under the MDR. This whitepaper has been written by Vanessa Plummer (Senior Regulatory Executive at Regulis), to provide affected device manufacturers with some guidance on the options available and how best to plan for the upcoming date of application.
Tips for writing an outstanding Clinical Overview
If you are writing or due to write a Clinical Overview, our whitepaper gives you some valuable guidance to help get you started or give you some tips for the future. Written by one of our experts, we are sure you will find it interesting and informative.
Implementation of the safety features under the Falsified Medicines Directive 2011/62/EU
This whitepaper, written by Susannah, outlines the responsibilities and actions marketing authorisation holders, manufacturing and importation authorisation holders, wholesale distributors, software providers and persons authorised or entitled to supply medicines to the public should take in order to comply with the new safety feature requirements under the Falsified Medicines Directive.
Literature searching in Pharmacovigilance: requirements and guidance
Literature searching in pharmacovigilance plays an important role in understanding the risk-benefit profile of medicinal products. This whitepaper discusses the importance of literature searching, use of literature databases and guidance to streamline the process. For further assistance please get in touch with us.
This whitepaper, written by the Regulis Team, provides information on medicinal product and medical device regulatory and pharmacovigilance requirements following Brexit.
QMS aspects of the Medical Device Regulations
Our latest whitepaper, written by Reihaneh summarises the major Quality Management System aspects of the Medical Device Regulations as the driver of all changes for the transition.
Mutual recognition of inspections of medicinal product manufacturers between the EU and the USA
This whitepaper, written by Audrey summarises the scope and impact of this agreement on the pharmaceutical manufacturers and the authorities in both regions.
New responsibilities for importers, distributors and authorised representatives for medical devices
This whitepaper by Susannah, outlines the responsibilities of medical device economic operators, in the Medical Device Regulations. If you are an EU Authorised Representative or an importer or a distributor of medical devices in the EU, this whitepaper will help you to familiarise yourself with your regulatory obligations.
Requirements of a person responsible for regulatory compliance for medical devices
This Whitepaper, written by Susannah discusses the practical aspects for device manufacturers. If you require support with this please get in touch with us.
Medical Device Regulation Requirements for Post-Market Surveillance, Vigilance and Post-Market Clinical Follow-up
This Whitepaper, written by Reihaneh will give you the latest information available on the Medical Device Regulation requirements. If you require support with this please get in touch with us.
Top tips for a successful EU Orphan Drug Designation application
Our Regulatory team have written this guidance document to successfully guide you through an Orphan Drug application. The team has significant in-depth knowledge and experience with ODAs so if you require support with an EU ODA including a company to act as Sponsor, please get in touch with us.
India’s Medical Devices Rules, 2017: A quantum leap capable of a revolution
On 1st January 2018, India is all set to embrace Medical Devices Rules, 2017; the first ever device-specific regulations for its US $ 5 billion medical device market which is largely unregulated at present. Our medical device team has written this whitepaper to elaborate what and how it will change under India’s new medical device regulations.
The new EU Medical Device Regulations - Impact on Notified Bodies and Manufacturers
Audrey Toulemonde from our devices team reports on the impact of the new regulations on Notified Bodies and manufacturers.
Patient friendly leaflets - writing and user testing
With Regulis’ many years of experience of writing and user testing hundreds of patient information leaflets, this paper describes the considerations and offers hints and tips for producing a patient-friendly leaflet that is in compliance with Council Directive 2001/83/EC (as amended by 2004/27/EC).
Global Early Access Schemes Part 2 of 2
What are Early Access Schemes? The final part of a two part white paper that Vanessa Damment from our Regulatory Affairs team has put together on Early Access Schemes, focusing on Japan, China, Australia and Canada.
Global Early Access Schemes Part 1 of 2
What are Early Access Schemes? Vanessa Damment from our Regulatory Affairs team has put together the first of a two part white paper on Early Access Schemes, the first one focuses on the EU and US.
Regulatory Affairs and Pharmacovigilance benefits of SME status
In this paper the Regulatory Affairs team review the benefits of SME status and how to obtain it.
A review of the EudraVigilance Stakeholder Change Management Plan
Upcoming Eudravigilance changes – What do you need to do to be ready?
The Proposed EU Medical Device Regulation and End of Own Brand Labelling
The Medical Device team at Regulis have published a white paper on the proposed EU Medical Device Regulation and end to Own Brand Labelling. The MHRA have now confirmed to all UK Notified Bodies that the present process of reviewing only the summary technical documentation (STED) in relation to OBL devices is no longer acceptable under EU Commission requirements. This papers describes how such manufacturers can continue to remain compliant under the new requirements.
Orphan Products in the EU
This detailed article reviewed information and metrics on orphan drug registration in the EU and makes recommendations for a successful orphan drug regulatory strategy.
The Medical Literature Monitoring of EMA
Vatsala Patel from the Pharmacovigilance team considers the responsibilities of marketing authorisation holders and the EMA around medical literature monitoring (MLM) and reviews the EMA’s MLM service over a year on from its introduction.
Placing a Class I Medical Device on the Market in the European Union and the Impact of the New Regulation
The Medical Devices team at Regulis discuss placing a Class I Medical Device on the market in the EU and the impact of the new device regulation. Updated in October 2018.
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