EU MDR Common Specifications (CS) Under Article 9: Complete Guide Including Annex XVI Products and 2026 Compliance

Common Specifications Are Mandatory Where Harmonised Standards Fall Short

European harmonised standards are voluntary — manufacturers can choose alternative solutions that achieve equivalent safety and performance. Common Specifications (CS) are different. Adopted via implementing acts by the European Commission under Article 9 of the MDR, CS carry a stronger regulatory weight: manufacturers must comply with CS unless they can duly justify that they have adopted solutions ensuring a level of safety and performance that is at least equivalent.

For products listed in Annex XVI (products without an intended medical purpose), CS compliance is even more stringent: manufacturers shall comply with the relevant CS, full stop. The option to justify alternative solutions does not apply.

This distinction makes CS one of the most consequential regulatory instruments under the MDR. Yet as of early 2026, many manufacturers remain unclear about when CS apply, what they contain, and how they differ from harmonised standards. This guide addresses every dimension of CS under the MDR — the legal basis in Articles 9 and 1(2), the product groups they cover, the specific implementing regulations, transitional timelines, and practical compliance strategies.

What Are Common Specifications?

Common Specifications are technical requirements adopted by the European Commission through implementing acts when:

1. No harmonised standards exist for a particular aspect of device safety or performance
2. Existing harmonised standards are not sufficient to address the relevant regulatory requirements
3. There is a need to address public health concerns that require uniform technical solutions across all Member States

CS are legally binding technical documents that specify how certain MDR requirements must be met. They are not standards developed by CEN/CENELEC through the voluntary consensus process — they are regulations adopted by the Commission after consultation with the Medical Device Coordination Group (MDCG).

The Three-Tier Compliance Framework

Legal Basis: Article 9 of the MDR

Article 9 MDR contains three paragraphs establishing the legal foundation for Common Specifications, complemented by Article 1(2) MDR which imposes a stricter regime on Annex XVI products:

Article 9(1) — Scope and Adoption

The Commission may adopt CS via implementing acts in respect of:

• The general safety and performance requirements set out in Annex I (GSPR)
• The technical documentation set out in Annexes II and III
• The clinical evaluation and post-market clinical follow-up set out in Annex XIV
• The requirements regarding clinical investigation set out in Annex XV

These implementing acts are adopted in accordance with the examination procedure referred to in Article 114(3), meaning the Commission must consult the MDCG before adoption.

Article 9(2) — Presumption of Conformity

Devices in conformity with CS are presumed to be in conformity with the MDR requirements covered by those CS. This mirrors the presumption of conformity granted by harmonised standards but applies to a different instrument.

Article 9(3) — The Equivalent Alternative Option

Manufacturers shall comply with CS unless they can duly justify that they have adopted solutions ensuring a level of safety and performance that is at least equivalent thereto. This is a critical distinction from harmonised standards:

• Harmonised standards: You can use any approach; using the standard just gives you a presumption of conformity
• Common Specifications: You must comply OR provide a robust justification for an equivalent alternative

Article 1(2) — Mandatory Compliance for Annex XVI Products

The "at least equivalent" escape clause in Article 9(3) does not apply to products listed in Annex XVI. Under Article 1(2) MDR, manufacturers of Annex XVI products "shall comply with those common specifications" — full stop. This is reinforced by Article 3 of Implementing Regulation (EU) 2022/2346, which requires manufacturers of Annex XVI products to apply the CS set out in that regulation's annexes. The Commission's view is that these products require uniform mandatory safety standards because they are brought into the MDR framework despite lacking a medical purpose.

Common Specifications for Annex XVI Products

The most significant application of CS to date is Implementing Regulation (EU) 2022/2346, which establishes common specifications for all six groups of products without an intended medical purpose listed in Annex XVI of the MDR.

The Six Product Groups in Annex XVI

What Regulation (EU) 2022/2346 Contains

The regulation is structured with product-specific annexes (Annexes I through VII) that address each of the six product groups. For each group, the CS specify:

1. Risk management requirements: Adapted from the GSPR in MDR Annex I but tailored to the specific risks of non-medical devices. Critically, the CS require that risk acceptance for Annex XVI products must be based on severity rather than probability — because no serious harm is considered acceptable for products without a medical purpose.

2. Safety requirements: Product-specific technical requirements for chemical, mechanical, and biological safety, including material characterization, sterility assurance where applicable, and performance specifications.

3. Information for safety (labeling and IFU): Specific requirements for instructions for use and labeling, including mandatory warnings about the non-medical nature of the product and the risks associated with the procedure.

4. Clinical evaluation requirements: Because Annex XVI products lack a medical purpose, they cannot demonstrate a clinical benefit. The CS require demonstration of safety and performance only, which represents a fundamental difference from the standard clinical evaluation framework.

The Reclassification Regulation (EU) 2022/2347

Adopted simultaneously with the CS regulation, Implementing Regulation (EU) 2022/2347 establishes classification rules for certain active products without an intended medical purpose. This was necessary because standard MDR classification rules (particularly Rules 9 and 10) assume a medical purpose and cannot be applied to Annex XVI products.

Key reclassifications include:

• Active products for liposuction: classified based on potential hazards
• Active products for body modification: classified based on invasiveness and duration

Common Specifications for Class D IVDs

Separate from Annex XVI products, the Commission has also adopted CS for high-risk IVD devices where harmonised standards are insufficient:

Regulation (EU) 2022/1107 — Class D IVD Common Specifications

Adopted on 4 July 2022 and applicable from 25 July 2024, this implementing regulation contains 13 annexes — one setting out general common specifications and twelve setting out CS for specific product groups of Class D IVD devices:

These CS establish minimum performance characteristics, analytical sensitivity and specificity requirements, and clinical performance expectations that manufacturers must meet for these high-risk IVD devices. An August 2024 Commission draft proposes extending 2022/1107 with additional CS for Hepatitis E virus, Toxoplasma gondii, Plasmodium spp., and four arboviruses (Chikungunya, dengue, West Nile, and Zika), but that amendment has not yet been adopted as of April 2026.

Transitional Timelines for Annex XVI Products

Regulation (EU) 2022/2346 establishes a phased transition for products without an intended medical purpose:

Conditions for Transitional Provisions

To benefit from transitional arrangements, the manufacturer must demonstrate:

• The product was lawfully marketed prior to June 22, 2023
• No significant changes have been made to the design or intended purpose
• Compliance with MDD requirements is maintained (for MDD-certified products)
• A written agreement for conformity assessment with a Notified Body has been signed (where applicable)

CS vs. Harmonised Standards: Complete Comparison

How to Demonstrate CS Compliance

For Technical Documentation

When demonstrating CS compliance in your technical documentation:

1. Identify all applicable CS: Determine which implementing regulations apply to your device based on product group (Annex XVI) or IVD class (Class D)
2. Map CS requirements to GSPR: Create a compliance matrix showing how each CS requirement addresses specific GSPR elements in MDR Annex I
3. Document compliance evidence: For each CS requirement, provide test reports, risk analyses, clinical data, or other evidence demonstrating compliance
4. Justify any deviations: If using alternative solutions (not permitted for Annex XVI), provide robust technical justification showing at least equivalent safety and performance
5. Update the Declaration of Conformity: Reference the applicable CS in the DoC alongside harmonised standards

For Notified Body Review

Notified Bodies will assess CS compliance as part of the conformity assessment:

• For Annex XVI products, CS compliance is a mandatory part of the review
• For other devices where CS have been adopted, the NB will assess whether the device meets CS requirements or whether the justification for alternative solutions is adequate
• CS compliance evidence should be clearly organized and cross-referenced in the technical documentation

CS and the 2025 Simplification Proposal

The European Commission's December 2025 proposal (COM(2025)1023) for targeted MDR amendments does not fundamentally change the CS framework under Article 9. However, the proposal does introduce:

• Broader acceptance of non-clinical data (including in silico and other New Approach Methodologies) for demonstrating safety and performance
• Flexibility to rely on published literature for clinical evaluation
• Potential for streamlined clinical evidence requirements that could affect how CS compliance is demonstrated for certain product groups

These proposed changes are under legislative review as of April 2026 and have not been adopted.

Frequently Asked Questions

What is the difference between Common Specifications and harmonised standards?

Common Specifications are technical requirements adopted by the European Commission through implementing acts (regulations). They are legally binding — manufacturers must comply or justify an equivalent alternative. Harmonised standards are voluntary documents developed by CEN/CENELEC that provide a presumption of conformity when applied. CS fill gaps where no harmonised standard exists or where existing standards are insufficient.

Are Common Specifications mandatory?

Yes, with one exception. Per Article 9(3), manufacturers must comply with CS unless they can duly justify that they have adopted solutions ensuring a level of safety and performance that is at least equivalent. For Annex XVI products (products without an intended medical purpose), Article 1(2) MDR and Article 3 of Regulation (EU) 2022/2346 make CS compliance fully mandatory with no alternative option.

Which products require compliance with Common Specifications?

As of 2026, CS have been adopted for three categories: (1) All six groups of products without an intended medical purpose listed in Annex XVI (Regulation (EU) 2022/2346); (2) Certain active Annex XVI products requiring reclassification (Regulation (EU) 2022/2347); and (3) Twelve groups of Class D IVD devices (Regulation (EU) 2022/1107) — blood group antigens (ABO, Rh, Kell, Duffy, Kidd), HIV, HTLV, hepatitis B, hepatitis C, hepatitis D, vCJD, CMV, EBV, Treponema pallidum, Trypanosoma cruzi, and SARS-CoV-2.

When must Annex XVI products comply with the CS?

The transition is phased. Products lawfully marketed before June 22, 2023 may continue under transitional provisions through June 22, 2028, provided no significant design changes are made and a written conformity assessment agreement is signed with a Notified Body. Products without such an agreement must be fully CS-compliant by the earlier deadlines.

Can I use alternative solutions instead of complying with CS?

For medical devices (not Annex XVI), Article 9(3) permits alternative solutions if you can duly justify that they ensure a level of safety and performance at least equivalent to the CS. This requires robust technical evidence in your technical documentation. For Annex XVI products, no alternative is permitted — CS compliance is mandatory.

How do CS relate to the GSPR in Annex I?

CS provide detailed technical specifications that address specific GSPR requirements. When a device conforms to applicable CS, it is presumed to conform with the GSPR elements covered by those CS. Your compliance matrix should map each CS requirement to the relevant GSPR clause in Annex I.

Who develops Common Specifications?

CS are developed by the European Commission after consultation with the Medical Device Coordination Group (MDCG), which includes representatives from all EU Member State Competent Authorities. They are adopted through the examination procedure under Article 114(3) of the MDR.

How many CS have been adopted under the MDR?

As of April 2026, three main implementing regulations containing CS have been adopted: (1) Regulation (EU) 2022/2346 for Annex XVI products; (2) Regulation (EU) 2022/2347 for reclassification of active Annex XVI products; and (3) Regulation (EU) 2022/1107 for Class D IVD devices. Additional CS may be adopted as the Commission identifies further gaps in harmonised standards coverage.

Do CS apply to legacy devices?

Legacy devices covered by transitional provisions under Regulation (EU) 2023/607 must eventually comply with all applicable MDR requirements, including CS, by the end of their transition period. For Annex XVI products, the CS transitional timelines in Regulation (EU) 2022/2346 apply specifically and independently of the general legacy device provisions.

Where can I find the adopted CS?

All adopted CS are published in the Official Journal of the European Union (OJEU) and are available on EUR-Lex. The European Commission's health portal also maintains a consolidated list of harmonised standards and common specifications under the MDR and IVDR.