Devices still on the EU market under MDD, AIMDD and IVDD certificates face fixed end dates in 2027, 2028 and 2029. Here is what changed, who qualifies for the extended timelines, and what your technical documentation needs to cover.

MDR and IVDR at a glance

Both are EU regulations governing medical devices, replacing older directives:

• MDR (EU 2017/745) replaced the Medical Device Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD).

• IVDR (EU 2017/746) replaced the In Vitro Diagnostic Medical Devices Directive (IVDD).

Both tightened requirements around clinical and performance evidence, post-market surveillance, traceability (Unique Device Identification) and Notified Body oversight.

Why the transition is still a live topic

The original deadlines proved unworkable. The EU has extended them through amending regulations: EU 2023/607 for MDR and EU 2024/1860 for IVDR. The extensions do not mean automatic extra time for everyone. Conditions to qualify include:

• A quality management system compliant with the regulation

• A formal application to a Notified Body by a set date

• A signed written agreement with that Notified Body

MDR: end of the transition period for legacy devices

For devices under MDD or AIMDD certificates:

• 31 December 2027: Class III and Class IIb implantable devices (except well-established technologies such as sutures, staples and screws)

• 31 December 2028: other Class IIb, Class IIa, sterile or measuring Class I, and devices that now need a Notified Body under MDR

These dates apply where the manufacturer lodged a Notified Body application by 26 May 2024 and signed a written agreement by 26 September 2024.

IVDR: end of the transition period for legacy devices

For devices under the IVDD:

• 31 December 2027: Class D, and devices with an IVDD certificate

• 31 December 2028: Class C

• 31 December 2029: Class B and sterile Class A

Next milestone: by 26 May 2027, applications to a Notified Body for Class B and sterile Class A devices must be submitted.

What sits inside technical documentation (Annex II and III)

• Device description and specifications

• Risk management file

• Design and manufacturing information

• Clinical evaluation (MDR) or performance evaluation (IVDR)

• Verification and validation evidence

• Labelling and instructions for use

• Evidence of conformity with the GSPRs in Annex I

• PMS plan, PSURs or PMS reports, and vigilance data

The technical documentation effort is usually described as the largest and most resource-intensive single component of the transition. Our guide to the EU MDR technical file explains how to structure it.

An ongoing compliance process

Managing the transition is now an ongoing compliance process rather than a one-time project. Annex III post-market surveillance documentation is a living document that must be kept current, not a one-off submission.

Start with a gap analysis

Consultant-led gap analyses can cost £3,000–£8,000 per technical file, depending on scope. Obodux does it in a fraction of the time and offers its gap analysis free. Request a free Obodux gap analysis or start a 4-week free trial.

Dates per Regulations (EU) 2023/607 and 2024/1860. Regulatory responsibility remains with the manufacturer. Always confirm dates and conditions against the current official texts.