Regulatory Updates
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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 ...
CONFIRMED: Switzerland adopts IvDO/IVDR
It’s official. Swissmedic will adopt the IvDO, which heavily references the IVDR. On 4 May 2022 Swissmedic updated its website ...
Turkey’s Status under the MDR and IVDR Published
A Notice to Stakeholders was released regarding the EU-Turkey Customs Union Agreement for medical devices. The gist of the document ...
New MDCG guidance: Verification of Class D IVDs
The In Vitro Diagnostic Regulation (IVDR) introduces a complex conformity assessment process for high-risk IVDs, including sample verification of Class ...
Lack of MHRA Approved Bodies for UKCA Marking
We hear a lot about the lack of Notified Body capacity and if companies will be able to CE mark ...
European industry groups call for a lengthier MDR transition period
It is no surprise, but there are major concerns regarding whether the industry is ready for the transition period to ...
Swissmedic Updates Registration Guidance & Announces New “Swiss EUDAMED”
Swissmedic published additional updates regarding the Swiss Single Registration Number (CHRN) and device registration requirements. Quick Refresher - The Swiss Single ...
Switzerland to implement IVDR
It appears that Swissmedic, despite some opposition by Swiss industry groups, will implement the IVDR on its date of application: ...
Upcoming Deadline to appoint Swiss Authorized Rep for Mid-risk Devices
The deadline to appoint a Swiss Authorized Representative (AR) for mid-risk devices is nearly here. Manufacturers of Class IIb non-implantable ...
New Notified Body audit guidance document for legacy devices
The Medical Device Coordination Group issued a new guidance document: MDCG 2022-4 - ‘Guidance on appropriate surveillance regarding the transitional ...
Has EUDAMED been delayed until 2023?
Originally, EUDAMED was to be fully functional on 26 May 2020 and align with the MDR's original date of application, ...
UK updates post-Brexit medical device guidance
It’s official, the registration transition period is over. The UK MHRA has updated its guidance on “Regulating medical devices in ...
Update: IVDR progressive roll-out approved
The EU Commission published that EU Parliament and Council have adopted the proposed amendment to the IVDR, to push out ...
New Guidance from the MDCG for Importers and Distributors
The EU Medical Device Coordination Group (MDCG) has released a new document related to the Importer (Art. 13) and Distributor ...
Will Switzerland leave the IVDR behind?
In April 2021, the Swiss Federal Council published the draft IVD Ordinance for public consultation. The draft regulation referred to ...
UK Low-risk Device Registration – Final Deadline Nearing
The deadline for low-risk device classes is nearing fast: 1 January 2022 for Class I devices and General IVDs The ...
Switzerland: Any updates to the MRA with Europe?
It has now been six months since the Swiss Federal Council and the EU Commission published that they cannot come ...
EUDAMED: New modules available for voluntary use
EUDAMED development is progressing further with the publication of two new modules: UDI/Devices registration and Notified Bodies & Certificates. With ...
Breaking News: EU Commission proposes IVDR delay
Citing the COVID-19 pandemic and a ‘grave shortage of notified body capacity’, the EU Commission has proposed delaying implementation dates ...
UK: Mid-risk Device Registration Deadline Approaching
Deadline for mid-risk device classes almost here: 1 September 2021 for Class IIb non-implantable, Class IIa, Annex II, List B ...