14/8/2023
A webinar for Medical Manufacturers looking to sell in the EU and USA.
Manufacturer’s Declaration in relation to Regulation (EU) 2023/607
18/7/2023
MedTech Europe* is making a template Manufacturer’s Declaration available to facilitate the declaration of manufacturers.
Harmonised standards for sterilisation of health care products
11/7/2023
The deadline for compliance with the new requirements is 20th July 2023.
Medical Device Regulations 2023 – UK Amendments
20/6/2023
Is the UK shadowing EU medical regulations?
18/5/2023
Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD.
EUMDR Transitional Provisions – Deep Dive
20/3/2023
Certain Medical Devices have the advantage of an extended transitional period!
27/2/2023
Here are some key points that medical device manufacturers should keep in mind from MDCG 2020-16 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under IVDR.
Best Medical Regulatory & Quality Compliance Consultancy
5/1/2023
Awards and recognitions motivate us to work more efficiently!
MedTech Regulatory Updates in EU
16/12/2022
Find all the Regulatory Updates for Medical Devices, Diagnostics and Digital Health in EU!
Common Specifications for Borderline Medical Devices in EU
5/12/2022
On December 01, 2022, the European Commission published Document C(2022)8626 - laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to R...
List of Common Specifications under Annex XVI – EU MDR
5/12/2022
EU MDR is getting serious. Dead Serious!
7/11/2022
This Joint Implementation Plan is the result of review by the MDCG including the
relevant sub-groups, with input from stakeholders. It has been endorsed in principle
in the MDCG meeting of 28 May 20...
