Swissmedic Seminar on IvDO/IVDR
Swissmedic hosted a seminar on the new IVD Ordinance in Switzerland. Read about the current situation with Europe, the IVDR, ...
New MDCG Guidance 2022-16 on Authorized Representatives
The MDCG released a new guidance document on EU Authorized Representatives (ARs). Find out the contractual obligations between Manufacturers and ...
Resources to Find: Notified Body Capacity, Timing and Fee Information
There is an extreme lack of transparency regarding Notified Body fees and timing. Find out how to combat this and ...
EU Commission: Notified Body MDR/IVDR Survey Results
The EU Commission published Notified Body statistics related to MDR/IVDR certification. Find out the average MDR/IVDR CE Marking processing times ...
Official Announcement: UKCA Marking Postponed & CE Marking Transition Period Extended
It's official. The MHRA announced a one year delay for UKCA Marking. And confirmed a 3-5 year transition period, to ...
UK MHRA Updates Vigilance Reporting Process
The MHRA has updated how incident reports can be submitted in the UK. Find out when the old system expires ...
Notified Body Position Paper: Timeframes to Implement New Guidance Documents
Team Notified Body (NB) has issued a Position Paper on transition timeframes to implement new MDCG guidance and best practice ...
Notified Body Position Paper: Use of Hybrid Audits
Team Notified Body (NB) published a position paper on hybrid audits for medical device certification. Find out here their recommendations ...
Update: Switzerland Registration Database (Swissdamed)
Swissmedic published an update regarding its registration database: the Swiss Database on Medical Devices (Swissdamed). Find out when it will ...
MDR/IVDR Manual on Borderline and Classification Released
The Borderline and Classification Working Group released the September 2022 ‘Manual on Borderline & Classification' for medical devices and IVDs. ...
UK MHRA Proposes New Fee Increase
The MHRA issued a consultation to increase fees for medical device clinical investigation notifications and device registrations. Find out the ...
MDCG Solutions: Notified Body Capacity & Manufacturer Readiness
The MDCG has proposed solutions, due to concerns about eventual lack of medical device supply in Europe. Find out how ...
Proposed Classifications for Products without a Medical Intended Purpose
The EU Commission proposed classifications for certain products without a medical claim, e.g., liposuction equipment & hair removal lasers. Find ...
Update: New 2022 Version of Blue Guide Released
The Blue Guide is an important tool to interpret EU Regulations, such as the definition of 'placing on the market'. ...
EU Commission Launches ‘Northern Ireland Protocol’ Infringements Against UK
The EU issued Northern Ireland Protocol infringements against the UK. The Protocol allows free movement of goods at the UK/EU ...
New UK Regulations: What to Expect and Timeframe to Comply
The MHRA issued an update on the new UK medical device regulation. What will be similar to the MDR/IVDR, what ...
New Guidance: Alternative Solutions until EUDAMED is Fully Functional
The Medical Device Coordination Group (MDCG) published new guidance on alternative solutions until EUDAMED is fully funcational. Find out the ...
Update: New EUDAMED ‘Go Live’ Date is Q2 2024
This month the EU Commission updated the EUDAMED 'go-live' date to Q2 2024, delaying EDUAMED by another year. Find out ...
New IVDR Updates: EU Reference Laboratories & Common Specifications
The EU Commission released three new IVDR Implementing Regulations: EU Reference Laboratory (EURL) fees / criteria and Common Specifications for ...
Approaching Deadline: Appoint Swiss Authorized Rep for Class I & System/Procedure Packs
The deadline to appoint a Swiss Authorized Representative for Class I devices and System/Procedure Packs is quickly approaching. Find out ...
MHRA Announces UKCA Marking to be Postponed: Find Out the New Dates Here
The MHRA released an update to the proposed new UK regulations. It offers further transition period for UKCA marking and ...
New Guidance: EU Certificates of Free Sale
The EU Competent Authorities issued a new guidance document June 2022 regarding medical device Certificates of Free Sale/Export Certificates. Read ...
MDCG Cautions Industry: Don’t Delay MDR Compliance
June 2022 MDCG Position Paper Warns: no further extensions will be granted to legacy devices. If you wait too long ...
New MDCG Guidance: FAQs on the EU UDI System
The MDCG has released a new guidance document on the European UDI system, required under the MDR/IVDR. Read here for ...
IVDR Round-Up: EU, Switzerland and UK
There is extensive activity surrounding the IVDR’s date of implementation today. Here we will discuss what is new, and the ...
What aspects of the IVDR apply to legacy devices? Find the answers in MDCG 2022-8
The Medical Device Coordination Group released a new guidance document; MDCG 2022-8: Regulation (EU) 2017/746 - application of IVDR requirements ...
New EU Commission Notice: Status of Switzerland Mutual Recognition Agreement & IVDR
Today the EU Commission published a ‘Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro ...
New Standards Harmonized to MDR/IVDR, including ISO 14971
Earlier this week new Harmonized European standards were adopted to be published in the Official Journal of the European Union ...
MHRA Updates List of UKCA Approved Bodies
The MHRA updated the designation scope for two UK Approved Bodies, reducing the UKCA coverage for medical device & IVD ...
MDCG Guidance: IVDR Legacy Device Transition and Significant Changes
The Medical Device Coordination Group (MDCG) has issued a new Guidance Document on significant changes for IVDs. Why does this ...