The new EU MDR Regulations Everything you needed to know in 2020
The final period for compliance with EU medical device regulation shall be May 26, 2020. Formed today, introducing the new regulations means that the medical device maker will invest in technology enabling tracking and improving safety management. EU MDRs introduce a new ID system based on the unique Device identifier UDI in medical devices.
What is The New EU MDR regulation?
The MDR replaces the directive 1999/43 ECE/CEE to implement active implementable medical technology in the EU. Suppose a new MDR is introduced by the midpoint of 2020; your company may not import or sell goods.
All Class 1 reusable medical devices in circulation after May 25, 2020, must comply with MDR regulations. They have also to contain numbers of notified bodies. This potentially resulted in significant delays in approval and inspection activities.
In most cases, CEPs will take up to 16 weeks to respond. Notified Bodies most likely offer additional services such as expedited reviews of documents or technical documents.
The new MDD is different in several important areas. The definition of the medical device has been enhanced. These are things including colored Contact lenses, cosmetic items, and devices intended to “predict and prognosis” a variety of maladies and disorders.
The MDR is developing deeper tracking mechanisms that allow manufacturers to trace individual products through the supply chain. The European Databank on Medical Devices (Eudamed) will expand to permit easier access to information on approved devices. There haven’t been exceptions for the moment. Under the rules, all currently approved devices will need a re-certification based on current standards.
Prepare an EU MDR Checklist: Overview
Martin Witte from TÜV SÜD talks you through MDR-audit preparation. Harmonized standards aren’t the best way to prove compliance. This does help a lot, but it’s not mandatory for users of other methods. The evidence does not have to be required to be approved, but it is necessary to meet and maintain MDR requirements.
Listed in the checklist is an actionable technical documentation checklist in 23 parts. The checklist aims to provide a technical documentation tool for manufacturers when assembling technical documentation as part of EU MDR 2017/745 requirements.
Sign Up For EU MDR Checklist
In the case of your company’s legal support and regulatory affairs, it provides a list of steps to take. Make sure you meet the requirements and sign up for these checklists today. Sign up for the EU MDR checklist to make sure that you comply with all EU device manufacturer mandates and all EU regulations as well as those of your firm’s regulator affairs and quality assurance.
GSPR – General Safety and Performance Requirements [EU MDR & EU IVDR]
For General Safety and Performance ” requirements of EU MDR and EU IVDR, you must provide your product with CE certification if you intend to get it labeled. Let’s discuss what you should know about GSPR. Let’s discuss how we can be successful for EU certification.
Let’s go over the General Safety and Performance Requirements.
What is GSPR?
The requirements for G-SPR are known as G’SPR requirements for general safety and performance. This is similar to the ‘essential requirements’ of MDD 93/42/EEC. Device manufacturers wanting CE-mark must comply with these obligations. They should demonstrate compliance for compliance with the GSPR. GSPRs enlisted for a medical device CE mark.
There are 23 requirements under MDR and 20 requirements under IVDR.
Those chapters in GSPR include:
EU MDR comprises
Chapter 1 (General requirements from 1 to 9), Chapter 2 (Design and manuf. from 10 to 20), Chapter 3 Labels & IFU (23).
EU IVDR Comprises
Chapter 1 (General Requirements from 1 to 8), Chapter 2 (Performance, Design, and Manuf. from 9 to 19), Chapter 3 Labels & IFU (20)
GSPR normally focuses on –
- Clinical safety
- Device performance
- Benefit-risk evaluation
- Risk reduction and control
How do I perform gap assessment for GSPR?
For any new product, performing gap assessment requires:
Analyze gaps in the critical prerequisite checks under MDD93/42/EEC. If the need is valid for your product, collect evidence from the input files of the design to show whether/not you have met the requirements. If there is no more evidence, there is an error. If any information is not available, consider this to be gap information.
The same gaps as MDR would exist as the GSPR has very few requirements similar to essential requirements. Gaps are analyzed using relevant ISO specifications of the product.
Analyze the gaps based on the applicable ISO Standards for specific products. The essential information should be mentioned in documents like clinical evaluation reports, essential requirement checklists, and product requirement documents. If these are not mentioned, then we will consider this as a gap.
Analyze the gap concerning the general safety and performance requirements. If the requirement of the product matches with the GSPR requirement, collect the evidence to prove that you have fulfilled the requirement. If no evidence is found, then it is considered as a gap.
EU MDR GSPR Template
Get Actionable Technical Documentation Requirements EU MDR Audit Readiness Checklist Download
EU MDR has minimum specifications on safety and quality for medical materials manufactured and introduced to Europe. It underwent major changes in 2017 to improve access to a single central European database, including EU databases and standardized data. It is vital to understand the most important aspects for May 2020, and this is why we have compiled an EU-MDR-Kit map with actionable technical documentation. In preparation for transition to the new MDR, many medical device manufacturers now conduct gap assessments in preparing for MDR changes.
We understand the importance of understanding key elements. Our experts will help you to prepare your actionable technical EU MDR checklist based on your specific requirement. Get it ready right now and download it for your future use.
MDR Checklist – Is Your Company Ready?
How to prioritize your actions for EU MDR readiness checklist? How to succeed in a timely and cost-effective manner?
The Checklist tool generally helps us to plan our workload effectively. But the new Medical Device Regulation (2017/745) is a mass of new requirements. And the checklist can become a nightmare or much too superficial on a tool.
This article offers a hands-on approach based on practical consulting experiences. The ultimate goal is to be regulatory compliant and, at the same time, to maintain or gain competitive advantages in the moving MedTech industry.
Take a Breath.
Simplify your QMS to speed your remediation projects.
Be aligned with the current medical product standard and increase your internal testing capabilities.
Use operational checklists for each GSPR Flash Audit (a flash audit for each CE-marked device)
Build your MDR Action Plan with our proven check-list (included Free)