EU Authorized Representative for India: From the Medical Devices Rules 2017 to MDR 2017/745

Two rulebooks share the abbreviation MDR

Inside an Indian regulatory affairs department, MDR means the Medical Devices Rules, 2017, made under the Drugs and Cosmetics Act, 1940 and administered by the Central Drugs Standard Control Organization. To a notified body in Warsaw or Milan, MDR means Regulation (EU) 2017/745. The two instruments were adopted within months of each other, both sort products into four grades of risk, and both use the letters A, B, C and D somewhere in the scheme. The similarity ends at the vocabulary.

This matters more than it sounds. Indian files are frequently well built, current and complete — and built to answer questions the European instrument never asks, while leaving unanswered the ones it does.

A, B, C and D in Delhi; I, IIa, IIb and III in Brussels

Indian classification is assigned by CDSCO, largely from published classification lists. European classification is not assigned by anyone: the manufacturer derives it by applying the rules in Annex VIII of the Regulation to the device's intended purpose, duration of contact and degree of invasiveness.

Import into India runs on a separate track again: an application on Form MD-14 leading to an import licence on Form MD-15, granted centrally for all four classes.

Why an Indian manufacturing licence gives nothing toward CE

A Form MD-9 licence is a permission to manufacture, granted after CDSCO has satisfied itself about premises, plant, competent technical staff and compliance with the quality management requirements set out in the Indian Rules. It is a real and demanding assessment. It is also an assessment against a different body of requirements, conducted by an authority with no standing in the Union.

Nothing in that process produces the three things Europe runs on: a finding against the general safety and performance requirements in Annex I of the Regulation, an EU declaration of conformity signed by the manufacturer, and — above class I — a certificate from a notified body designated under Article 42. An import licence on Form MD-15 has the same limitation running the other way.

The phase-in that rebuilt Indian dossiers, and why Europe never noticed

Notification S.O. 648(E) of 11 February 2020 brought all medical devices within the regulated definition, and CDSCO then ran the change in stages through its online system for medical devices: from 1 October 2022 Class A and Class B devices fell under the licensing regime, and from 1 October 2023 Class C and Class D devices followed.

The practical consequence is a large cohort of Indian manufacturers whose first serious regulatory dossier was assembled between 2020 and 2023. Those files are recent and orderly. They are also organised entirely around Indian schedules, Indian labelling rules and Indian quality requirements, which is why a notified body opening one finds a well-kept document set that answers the wrong questionnaire.

Consumables, instruments and the sterile barrier

India's device exports to Europe are dominated by volume consumables and instruments rather than by high-technology equipment: syringes, needles and cannulae, intravenous administration sets, catheters, sutures, surgical instruments, orthopaedic implants at the higher end, and a fast-growing in vitro diagnostic sector. Each of those families hits a specific piece of Annex VIII.

• A surgically invasive device for transient use is class IIa under Rule 6 unless a listed exception applies, so a great deal of routine Indian production sits above the self-declaration line.
• A non-invasive device intended for channelling or storing blood, body liquids, cells or tissues for eventual infusion or administration is class IIa under Rule 2, and a blood bag is class IIb.
• Anything placed on the market in sterile condition draws a notified body into the conformity assessment for the sterility aspects, whatever class the device would otherwise be.
• An implantable device carries the heaviest route in the Regulation, including a technical documentation assessment for every device rather than a representative sample.

IVDs: one Indian licence, four IVDR classes

India licenses in vitro diagnostics through the same Rules and the same forms. The Union does not. Regulation (EU) 2017/746 is a separate instrument with its own classification rules and its own class A to D, and the letters again mean something else. Only the lowest class escapes a notified body:

"Manufacturers of class A devices, other than devices for performance study, shall declare the conformity of their products by issuing the EU declaration of conformity referred to in Article 17, after drawing up the technical documentation set out in Annexes II and III." (IVDR Art. 48(10))

Class B, class C and class D in vitro diagnostics all involve a notified body, and a class A device placed on the market in sterile condition draws one in for the sterility aspects. For Indian reagent and rapid-test manufacturers who have historically self-certified for Europe, this is the largest single change in their working assumptions.

From an MD-9 dossier to Annex II, and into twenty-four languages

Rebuilding is usually a matter of addition rather than replacement. The elements an Indian file most often lacks are a requirement-by-requirement demonstration against Annex I with the evidence identified for each line, a clinical evaluation structured to Annex XIV, a post-market surveillance plan and periodic safety update report, risk management carried through the product lifecycle, and UDI assignment including the Basic UDI-DI that identifies the device in EUDAMED.

Then there is language, which Indian exporters consistently underestimate because the domestic label is already in English:

"Manufacturers shall ensure that the device is accompanied by the information set out in Section 23 of Annex I in an official Union language(s) determined by the Member State in which the device is made available to the user or patient." (MDR Art. 10(11))

Each Member State decides which official Union language it requires. A single English instruction for use will not carry a shipment through Germany, France, Poland and Spain. We handle the Article 11 mandate, the single registration number and the EUDAMED actor and device entries as one exercise; the detail of the service sits on our EU Authorized Representative and EUDAMED registration pages, and the class-based annual fees are published on pricing.

Four questions we answer for Indian manufacturers most weeks

We are licensed by CDSCO under the Medical Devices Rules, 2017. Does that count in Europe?

No. A CDSCO licence is evidence of compliance with Indian law and nothing else. It is worth keeping in the technical file as background about your manufacturing controls, but a notified body will not treat it as conformity assessment evidence and no competent authority will accept it in place of a declaration of conformity.

We hold ISO 13485 certification alongside our Form MD-9 licence. Is that enough for a class IIa device?

It is a strong start and it is not sufficient. An MDR quality management system certificate is issued under Annex IX Chapter I by a notified body designated under the Regulation, against requirements written in Article 10(9). A general ISO 13485 certificate from a certification body that is not so designated does not substitute for it, although it usually shortens the gap analysis considerably.

Our device is Class A in India. Can we self-declare in Europe as well?

Only if the Annex VIII rules put it in class I and it is neither sterile, nor measuring, nor a reusable surgical instrument. Indian Class A includes a good deal of product that European rules place higher, and the sterile presentation that is routine for Indian consumables pulls a notified body in on its own.

Do we need a separate representative for our IVD range?

The mandate under Article 11 of the MDR and the mandate under Article 11 of the IVDR are separate legal appointments, even where the same firm accepts both. If you export devices and in vitro diagnostics, say so at the outset so both are set up together rather than discovered later. Tell us what you export and we will map the portfolio before quoting.