ISO publishes the new ISO 9001:2026
ISO 9001:2026 replaces the 2015 edition: quality culture, risks and opportunities, change management and a three-year transition ending on 30-09-2029.
Read more
September 21, 2026
Blog
Regulatory news and updates
The latest updates from the medical sector and MeDev Consulting news.
September 20, 2026
IVD controls without assigned values: what MDCG 2020-16 rev.5 clarifies
Revision 5 of MDCG 2020-16 (September 2026) changes only Rule 7 of the IVDR. We explain where the class B boundary now lies for quality control materials.
Read more
September 2, 2026
ANVISA publishes two guidance manuals for the regularisation of medical devices
ANVISA publishes two manuals for regularisation in Brazil: notification of class I and II materials (RDC 751/2022) and IVD products (RDC 830/2023).
Read more
August 24, 2026
ISO 10993-3:2026 - New edition
New 2026 edition of EN ISO 10993-3 on biological evaluation: genotoxicity, carcinogenicity and reproductive toxicity of medical devices.
Read more
August 24, 2026
IVDR: if you manufacture a 'legacy' class C device, you have little more than 30 days left.
IVDs self-declared under Directive 98/79/EC that are now class C under IVDR: little more than 30 days of the transition period remain.
Read more
August 24, 2026
EHDS Regulation 2025/327: CE marking becomes mandatory for EHR systems
The EHDS Regulation (EU) 2025/327 makes CE marking mandatory for electronic health record systems: deadlines, requirements and who is affected.
Read more
August 4, 2026
Electronic instructions for use (eIFU): what manufacturers and importers need to consider
Regulation (EU) 2025/1234 broadens electronic instructions for use (eIFU): which devices may replace paper IFU and under what requirements.
Read more
July 27, 2026
New MDCG 2026-5
MDCG 2026-5 clarifies that only the manufacturer may assign the UDI and register the device in EUDAMED, even when sold under a distributor's brand.
Read more
July 19, 2026
New MIR 7.3.1 form: mandatory from 1 May 2026
The Commission updates the MIR form for reporting serious incidents (MDR Art. 87): version 7.3.1 is mandatory from 1 May 2026.
Read more
July 15, 2026
RECOPS live since 28/05/2026 and mandatory since 15/06/2026
RECOPS, the Spanish application replacing CCPS and RPS, is mandatory since 15 June 2026 to register medical devices marketed in Spain.
Read more
May 19, 2026
EUDAMED 2.27.0 released, the version that becomes mandatory from 28 May 2026 for SRN and new devices – 28 Nov 2026 for all devices
EUDAMED 2.27.0 released, the version that becomes mandatory from 28 May 2026 for SRN and new devices – 28 Nov 2026 for all devices: we help you through the process …
Read more
May 8, 2026
Before 26 November 2026 → It will be mandatory to have your devices registered in EUDAMED, both for manufacturers and for importers of medical devices under the MDD
By 26 November 2026 legacy devices under the MDD must be registered in EUDAMED: the duty lies with the manufacturer, not the NB or the EC REP.
Read more
May 3, 2026
28 May 2026 → EUDAMED becomes mandatory for medical device manufacturers
Manufacturers must focus on completing the ACT and UDI/DEV modules, which are their direct responsibility: There is no more time to lose.
Read more
July 24, 2023
MDD \"Legacy\" New manufacturer's declaration of conformity in relation to Regulation (EU) 2023/607
MedTech Europe publishes a manufacturer declaration template on Regulation (EU) 2023/607 and the validity of MDD and AIMDD certificates.
Read more
May 31, 2023
The European Commission publishes the confirmation letter template required to extend the MDD periods
The European Commission publishes the 'Confirmation Letter' template required to apply the extended transitional periods of Regulation (EU) 2023/607
Read more
May 31, 2023
The MHRA announces an additional extension of the UKCA marking standstill period
The MHRA announces an additional twelve-month extension of the UKCA marking standstill period for medical devices and IVDs in the UK.
Read more
May 15, 2023
New update of MDCG 2020-3 significant changes for devices under MDD
Update of MDCG 2020-3 guidance on significant changes to MDD/AIMDD legacy devices under MDR Article 120 and Regulation 2023/607.
Read more
April 5, 2023
AEMPS updates Instruction PS1/2022 to include the requirements established in Real Decreto 192/2023 (Royal Decree) of 21 March, regulating medical devices.
AEMPS updates instruction PS1/2022 with the requirements of Royal Decree 192/2023 for medical device manufacturers, importers and groupers.
Read more
March 27, 2023
Questions and Answers: Extension of the transitional periods MDD
Questions and Answers: The Commission proposes an extension of the transitional periods for the application of the Medical Devices Regulation
Read more
March 22, 2023
Is my device a medical device?
I want to manufacture or import a product, but… is it a medical device? Or is it an in vitro diagnostic medical device? How can I tell?
Read more
March 22, 2023
The new Real Decreto (Royal Decree) on Medical Devices was published today in the BOE, 21 March 2023
It is RD 192/2023 of 21 March 2023. The Real Decreto (Royal Decree) enters into force tomorrow (23 March).
Read more
March 21, 2023
New Royal Decree on medical devices
The Council of Ministers approves the Royal Decree on medical devices, also covering permanent make-up instruments and their accessories.
Read more
March 20, 2023
Extension of the validity period of the MDD Directive
Regulation (EU) 2023/607 has entered into force, extending the validity of certificates issued in accordance with Directives 90/385/EEC and 93/42/EEC.
Read more
December 10, 2022
MDCG: new MDCG 2022-18 on legacy devices whose MDD certificate expires before the issuance of an MDR certificate
MDCG 2022-18 explains how to apply MDR Article 97 to legacy devices whose MDD certificate expired before an MDR certificate was issued.
Read moreDecember 6, 2022
MDCG 2022-17 Hybrid audits
MDCG 2022-17 defines notified body hybrid audits: partly on-site and partly remote, and the requirements for carrying them out.
Read more